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W Jack Rejeski,1 Robert Axtell,2 Roger Fielding,3 Jeffrey Katula,1 Abby C King,4 Todd M Manini,5 Anthony P Marsh,1 Marco Pahor,5 Alvito Rego,6 Catrine Tudor-Locke,7 Mark Newman,8 Michael P Walkup,9 Michael E Miller9 On behalf of the LIFE Study Investigator Group 1Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC, 2Exercise Science Department, Southern Connecticut State University, New Haven, CT, 3Nutrtion, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer US Department of Agriculture Human Nutrition Research Center on Aging at Tufts University, Boston, MA, 4Department of Health Research and Policy and Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, Palo Alto, CA, 5Department of Aging and Geriatric Research, College of Medicine, University of Florida, Gainesville, FL, 6Department of Internal Medicine, Northwestern School of Medicine, Chicago, IL, 7Pennington Biomedical Research Center, Baton Rouge, LA, 8Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, 9Department of Biostatistical Sciences, Division of Public Health Sciences, School of Medicine, Wake Forest University, Winston-Salem, NC, USA Abstract: The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase III randomized controlled clinical trial (Clinicaltrials.gov identifier: NCT01072500) that will provide definitive evidence regarding the effect of physical activity (PA) on major mobility disability in older adults (70–89 years old) who have compromised physical function. This paper describes the methods employed in the delivery of the LIFE Study PA intervention, providing insight into how we promoted adherence and monitored the fidelity of treatment. Data are presented on participants' motives and self-perceptions at the onset of the trial along with accelerometry data on patterns of PA during exercise training. Prior to the onset of training, 31.4% of participants noted slight conflict with being able to meet the demands of the program and 6.4% indicated that the degree of conflict would be moderate. Accelerometry data collected during PA training revealed that the average intensity – 1,555 counts/minute for men and 1,237 counts/minute for women – was well below the cutoff point used to classify exercise as being of moderate intensity or higher for adults. Also, a sizable subgroup required one or more rest stops. These data illustrate that it is not feasible to have a single exercise prescription for older adults with compromised function. Moreover, the concept of what constitutes "moderate" exercise or an appropriate volume of work is dictated by the physical capacities of each individual and the level of comfort/stability in actually executing a specific prescription. Keywords: aging, accelerometry, physical disability, compromised physical function, older adults

We examined the hypothesis that physical activity will have favorable effects on measures of self-efficacy for a 400-m walk and satisfaction with physical functioning in older adults 70+ years of age who have deficits in mobility. We randomized a total of 412 adults aged 70-89 years at elevated risk for mobility disability to either a physical activity or a successful aging educational control intervention for 12 months. Participants in the physical activity intervention had more favorable changes in both outcomes as a result of treatment than those in the successful aging intervention. Gender, age, and scores on a short physical performance battery did not moderate these effects. Physical activity is an effective means of intervening on self-efficacy and satisfaction with physical function in older adults with impaired lower extremity functioning. This is an important finding in light of the importance of these process variables in behavior change and quality of life. [ABSTRACT FROM AUTHOR]

Introduction/purpose: Lower cardiorespiratory fitness and obesity may accelerate aging processes. The degree to which changes in fitness and body mass index (BMI) may alter the rate of aging may be important for planning treatment. We assessed cross-sectional and longitudinal associations that cardiorespiratory fitness and BMI had with a deficit accumulation frailty index (FI)., Methods: Fitness, based on standardized graded exercise tests, and weight to calculate BMI at baseline and year 4 were collected from 3944 participants aged 45-76 yr in the Action for Health in Diabetes (Look AHEAD) randomized controlled clinical trial. A validated 38-item deficit accumulation FI was used as a marker of aging. Associations between baseline and changes in fitness and BMI with changes in FI were assessed using linear models., Results: Both baseline and 4-yr changes in fitness and BMI were independently associated with 4-yr changes in frailty (all P < 0.001). Mean (95% confidence interval) changes in FI ranged from -0.019 (-0.024, -0.013) for participants in the group with the greatest fitness increase and BMI loss to 0.029 (0.024, 0.034) for participants in the group with the greatest fitness loss and BMI gain. Associations of 4-yr changes in fitness and BMI with FI changes were similar across subgroups based on age, sex, baseline BMI, diabetes duration, and cardiovascular disease history. Increased fitness across 4 yr was associated with less FI accumulation independent of baseline fitness., Conclusions: Adults with type 2 diabetes and overweight or obesity may slow aging processes captured by an FI by increasing their cardiorespiratory fitness and losing weight., (Copyright © 2023 by the American College of Sports Medicine.)

Introduction: Diabetes and overweight/obesity are described as accelerating aging processes, yet many individuals with these conditions maintain high levels of cognitive and physical function and independence late into life. The Look AHEAD Aging study is designed to identify 20-year trajectories of behaviors, risk factors, and medical history associated with resilience against geriatric syndromes and aging-related cognitive and physical functional deficits among individuals with these conditions., Methods: Look AHEAD Aging extends follow-up of the cohort of the former 10-year Look AHEAD trial. The original cohort ( N = 5145) was enrolled in 2001 to 2004 when participants were aged 45 to 76 years and randomly assigned to a multidomain intensive lifestyle intervention (ILI) or a diabetes support and education (DSE) condition. The trial interventions ceased in 2012. Clinic-based follow-up continued through 2020. In 2021, the cohort was invited to enroll in Look AHEAD Aging, an additional 4-year telephone-based follow-up (every 6 months) enhanced with Medicare linkage. Standardized protocols assess multimorbidity, physical and cognitive function, health care utilization, and health-related quality of life., Results: Of the original N = 5145 Look AHEAD participants, N = 1552 active survivors agreed to participate in Look AHEAD Aging. At consent, the cohort's mean age was 76 (range 63 to 94) years and participants had been followed for a mean of 20 years. Of the original Look AHEAD enrollees, those who were younger, female, or with no history of cardiovascular disease were more likely to be represented in the Look AHEAD Aging cohort. Intervention groups were comparable with respect to age, diabetes duration, body mass index, insulin use, hypertension, cardiovascular disease, and cognitive function. ILI participants had significantly lower deficit accumulation index scores., Discussion: By continuing the long-term follow-up of an extensively characterized cohort of older individuals with type 2 diabetes, Look AHEAD Aging is well positioned to identify factors associated with resilience against aging-related conditions., Competing Interests: M.A.E. and T.B. receive research support from the Alzheimer's Association. The authors collectively have no other relationships related to the content of the manuscript to disclose. Author disclosures are available in the supporting information., (© 2023 The Authors. Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)

Background Overweight and obesity are associated with adverse functional outcomes in people with peripheral artery disease (PAD). The effects of weight loss in people with overweight/obesity and PAD are unknown. Methods The PROVE (Promote Weight Loss in Obese PAD Patients to Prevent Mobility Loss) Trial is a multicentered randomized clinical trial with the primary aim of testing whether a behavioral intervention designed to help participants with PAD lose weight and walk for exercise improves 6-minute walk distance at 12-month follow-up, compared with walking exercise alone. A total of 212 participants with PAD and body mass index ≥25 kg/m 2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coaching. The primary outcome is 12-month change in 6-minute walk distance. Secondary outcomes include total minutes of walking exercise/wk at 12-month follow-up and 12-month change in accelerometer-measured physical activity, the Walking Impairment Questionnaire distance score, and the Patient-Reported Outcomes Measurement Information System mobility questionnaire. Tertiary outcomes include 12-month changes in perceived exertional effort at the end of the 6-minute walk, diet quality, and the Short Physical Performance Battery. Exploratory outcomes include changes in gastrocnemius muscle biopsy measures of mitochondrial cytochrome C oxidase activity, mitochondrial biogenesis, capillary density, and inflammatory markers. Conclusions The PROVE randomized clinical trial will evaluate the effects of exercise with an intervention of coaching and a smartphone application designed to achieve weight loss, compared with exercise alone, on walking performance in people with PAD and overweight/obesity. Results will inform optimal treatment for the growing number of patients with PAD who have overweight/obesity. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04228978.

Objective: We aimed to determine the association of the time-of-day of bout-related moderate-to-vigorous physical activity (bMVPA) with changes in glycemic control across 4 years in adults with overweight/obesity and type 2 diabetes., Research Design and Methods: Among 2,416 participants (57% women; mean age, 59 years) with 7-day waist-worn accelerometry recording at year 1 or 4, we assigned bMVPA timing groups based on the participants' temporal distribution of bMVPA at year 1 and recategorized them at year 4. The time-varying exposure of bMVPA (≥10-min bout) timing was defined as ≥50% of bMVPA occurring during the same time period (morning, midday, afternoon, or evening), <50% of bMVPA in any time period (mixed), and ≤1 day with bMVPA per week (inactive)., Results: HbA1c reduction at year 1 varied among bMVPA timing groups (P = 0.02), independent of weekly bMVPA volume and intensity. The afternoon group had the greatest HbA1c reduction versus inactive (-0.22% [95%CI -0.39%, -0.06%]), the magnitude of which was 30-50% larger than the other groups. The odds of discontinuation versus maintaining or initiating glucose-lowering medications at year 1 differed by bMVPA timing (P = 0.04). The afternoon group had the highest odds (odds ratio 2.13 [95% CI 1.29, 3.52]). For all the year-4 bMVPA timing groups, there were no significant changes in HbA1c between year 1 and 4., Conclusions: bMVPA performed in the afternoon is associated with improvements in glycemic control in adults with diabetes, especially within the initial 12 months of an intervention. Experimental studies are needed to examine causality., (© 2023 by the American Diabetes Association.)

Background: Little is known about the effect of exercise modality during a dietary weight loss program on muscle size and quality, as measured by computed tomography (CT). Even less is known about how CT-derived changes in muscle track with changes in volumetric bone mineral density (vBMD) and bone strength., Methods: Older adults (66 ± 5 years, 64 % women) were randomized to 18-months of diet-induced weight loss (WL), WL with aerobic training (WL + AT), or WL with resistance training (WL + RT). CT-derived muscle area, radio-attenuation and intermuscular fat percentage at the trunk and mid-thigh were determined at baseline (n = 55) and 18-month follow-up (n = 22-34), and changes were adjusted for sex, baseline value, and weight lost. Lumbar spine and hip vBMD and finite element-derived bone strength were also measured., Results: After adjustment for the weight lost, muscle area losses at the trunk were -7.82 cm 2 [-12.30, -3.35] for WL, -7.72 cm 2 [-11.36, -4.07] for WL + AT, and -5.14 cm 2 [-8.65, -1.63] for WL + RT (p < 0.001 for group differences). At the mid-thigh, decreases were -6.20 cm 2 [-10.39, -2.02] for WL, -7.84 cm 2 [-11.19, -4.48] for WL + AT, and -0.60 cm 2 [-4.14, 2.94] for WL + RT; this difference between WL + AT and WL + RT was significant in post-hoc testing (p = 0.01). Change in trunk muscle radio-attenuation was positively associated with change in lumbar bone strength (r = 0.41, p = 0.04)., Conclusions: WL + RT better preserved muscle area and improved muscle quality more consistently than WL + AT or WL alone. More research is needed to characterize the associations between muscle and bone quality in older adults undertaking weight loss interventions., Competing Interests: Declaration of competing interest The authors declare no relevant conflicts of interest. Data that support the findings of this study are available from the corresponding author upon reasonable request., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Obesity is a risk factor for chronic diseases and moderate weight loss is generally recommended. Energy restriction results in the loss of hip bone mineral density (BMD) in older adults, but there is no consistent decline at the lumbar spine (LS), possibly due to vertebral abnormalities although this may also be dependent on the amount of weight loss. In this secondary analysis of weight loss trials investigating BMD and trabecular bone score (TBS) changes over 12-18 months, 92 postmenopausal women (60.8 ± 5.8 years; body mass index 32.7 ± 4.4 kg/m 2 ) without osteoporosis, were divided into two groups: those who lost < 5% body weight (minimal) or ≥ 5% (moderate). Hip and LS-BMD and TBS were measured at baseline, 6 and 12-18 months. Exclusion of vertebral abnormalities (VE) was used to calculate BMD at the spine (LS-BMD-VE) using standard guidelines. Women lost 2.3 ± 2.4% and 8.5 ± 4.7% weight in the minimal and moderate weight loss groups, respectively. Over one third of the women had at least one vertebral abnormality or partially degraded TBS at baseline that worsened after weight loss, increasing to over 50% in this population (p < 0.05). TBS and hip BMD decreased with weight loss (p < 0.05), but LS-BMD did not decrease significantly. However, after excluding vertebral abnormalities, the LS-BMD-VE decreased in the entire population (p < 0.01), and by 1.7 ± 4.3% in the moderate weight loss group. This study suggests that older women without osteoporosis have vertebral abnormalities that obfuscated declines in BMD with weight loss, indicating that bone at the spine is further compromised., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: Youth football athletes are exposed to repetitive subconcussive head impacts during normal participation in the sport, and there is increasing concern about the long-term effects of these impacts. The objective of the current study was to determine if strain-based cumulative exposure measures are superior to kinematic-based exposure measures for predicting imaging changes in the brain., Methods: This prospective, longitudinal cohort study was conducted from 2012 to 2017 and assessed youth, male football athletes. Kinematic data were collected at all practices and games from enrolled athletes participating in local youth football organizations in Winston-Salem, North Carolina, and were used to calculate multiple risk-weighted cumulative exposure (RWE) kinematic metrics and 36 strain-based exposure metrics. Pre- and postseason imaging was performed at Wake Forest School of Medicine, and diffusion tensor imaging (DTI) measures, including fractional anisotropy (FA), and its components (CL, CP, and CS), and mean diffusivity (MD), were investigated. Included participants were youth football players ranging in age from 9 to 13 years. Exclusion criteria included any history of previous neurological illness, psychiatric illness, brain tumor, concussion within the past 6 months, and/or contraindication to MRI., Results: A total of 95 male athletes (mean age 11.9 years [SD 1.0 years]) participated between 2012 and 2017, with some participating for multiple seasons, resulting in 116 unique athlete-seasons. Regression analysis revealed statistically significant linear relationships between the FA, linear coefficient (CL), and spherical coefficient (CS) and all strain exposure measures, and well as the planar coefficient (CP) and 8 strain measures. For the kinematic exposure measures, there were statistically significant relationships between FA and RWE linear (RWEL) and RWE combined probability (RWECP) as well as CS and RWEL. According to area under the receiver operating characteristic (ROC) curve (AUC) analysis, the best-performing metrics were all strain measures, and included metrics based on tensile, compressive, and shear strain., Conclusions: Using ROC curves and AUC analysis, all exposure metrics were ranked in order of performance, and the results demonstrated that all the strain-based metrics performed better than any of the kinematic metrics, indicating that strain-based metrics are better discriminators of imaging changes than kinematic-based measures. Studies relating the biomechanics of head impacts with brain imaging and cognitive function may allow equipment designers, care providers, and organizations to prevent, identify, and treat injuries in order to make football a safer activity.

Background: Elevated interleukine-6 (IL-6) and C-reactive protein (CRP) are associated with aging-related reductions in physical function, but little is known about their independent and combined relationships with major mobility disability (MMD), defined as the self-reported inability to walk a quarter mile., Methods: We estimated the absolute and relative effect of elevated baseline IL-6, CRP, and their combination on self-reported MMD risk among older adults (≥68 years; 59% female) with slow gait speed (<1.0 m/s). Participants were MMD-free at baseline. IL-6 and CRP were assessed using a central laboratory. The study combined a cohort of community-dwelling high-functioning older adults (Health ABC) with 2 trials of low-functioning adults at risk of MMD (LIFE-P, LIFE). Analyses utilized Poisson regression for absolute MMD incidence and proportional hazards models for relative risk., Results: We found higher MMD risk per unit increase in log IL-6 (hazard ratio [HR] = 1.26; 95% confidence interval [95% CI] 1.13-1.41). IL-6 meeting predetermined threshold considered to be high (>2.5 pg/mL) was similarly associated with higher risk of MMD (HR = 1.31; 95% CI 1.12-1.54). Elevated CRP (CRP >3.0 mg/L) was also associated with increased MMD risk (HR = 1.38; 95% CI 1.10-1.74). The CRP effect was more pronounced among participants with elevated IL-6 (HR = 1.62; 95% CI 1.12-2.33) compared to lower IL-6 levels (HR = 1.19; 95% CI 0.85-1.66)., Conclusions: High baseline IL-6 and CRP were associated with an increased risk of MMD among older adults with slow gait speed. A combined biomarker model suggests CRP was associated with MMD when IL-6 was elevated., (© The Author(s) 2021. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objective: The Action for Health in Diabetes (Look AHEAD) study previously reported that intensive lifestyle intervention (ILI) reduced incident depressive symptoms and improved health-related quality of life (HRQOL) over nearly 10 years of intervention compared with a control group (the diabetes support and education group [DSE]) in participants with type 2 diabetes and overweight or obesity. The present study compared incident depressive symptoms and changes in HRQOL in these groups for an additional 6 years following termination of the ILI in September 2012., Methods: A total of 1,945 ILI participants and 1,900 DSE participants completed at least one of four planned postintervention assessments at which weight, mood (via the Patient Health Questionnaire-9), antidepressant medication use, and HRQOL (via the Medical Outcomes Scale, Short Form-36) were measured., Results: ILI participants and DSE participants lost 3.1 (0.3) and 3.8 (0.3) kg [represented as mean (SE); p = 0.10], respectively, during the 6-year postintervention follow-up. No significant differences were observed between groups during this time in incident mild or greater symptoms of depression, antidepressant medication use, or in changes on the physical component summary or mental component summary scores of the Short Form-36. In both groups, mental component summary scores were higher than physical component summary scores., Conclusions: Prior participation in the ILI, compared with the DSE group, did not appear to improve subsequent mood or HRQOL during 6 years of postintervention follow-up., (© 2021 The Obesity Society.)

Objective: Moderate- to vigorous-intensity physical activity (MVPA) improves cardiovascular health. Few studies have examined MVPA timing. We examined the associations of timing of bout-related MVPA with cardiorespiratory fitness and cardiovascular risk in adults with type 2 diabetes., Research Design and Methods: Baseline 7-day hip-worn accelerometry data from Look AHEAD participants ( n = 2,153, 57% women) were analyzed to identify bout-related MVPA (≥3 METs/min for ≥10 min). Cardiorespiratory fitness was assessed by maximal graded exercise test. Participants were categorized into six groups on the basis of the time of day with the majority of bout-related MVPA (METs × min): ≥50% of bout-related MVPA during the same time window (morning, midday, afternoon, or evening), <50% of bout-related MVPA in any time category (mixed; the reference group), and ≤1 day with bout-related MVPA per week (inactive)., Results: Cardiorespiratory fitness was highly associated with timing of bout-related MVPA ( P = 0.0005), independent of weekly bout-related MVPA volume and intensity. Importantly, this association varied by sex ( P = 0.02). In men, the midday group had the lowest fitness (β = -0.46 [95% CI -0.87, -0.06]), while the mixed group in women was the least fit. Framingham risk score (FRS) was associated with timing of bout-related MVPA ( P = 0.02), which also differed by sex ( P = 0.0007). The male morning group had the highest 4-year FRS (2.18% [0.70, 3.65]), but no association was observed in women., Conclusions: Timing of bout-related MVPA is associated with cardiorespiratory fitness and cardiovascular risk in men with type 2 diabetes, independent of bout-related MVPA volume and intensity. Prospective studies are needed to determine the impacts of MVPA timing on cardiovascular health., (© 2021 by the American Diabetes Association.)

Rationale: Weight loss is recommended to treat obstructive sleep apnea (OSA). Objectives: To determine whether the initial benefit of intensive lifestyle intervention (ILI) for weight loss on OSA severity is maintained at 10 years. Methods: Ten-year follow-up polysomnograms of 134 of 264 adults in Sleep AHEAD (Action for Health in Diabetes) with overweight/obesity, type 2 diabetes mellitus, and OSA were randomized to ILI for weight loss or diabetes support and education (DSE). Measurements and Main Results: Change in apnea-hypopnea index (AHI) was measured. Mean ± SE weight losses of ILI participants of 10.7 ± 0.7, 7.4 ± 0.7, 5.1 ± 0.7, and 7.1 ± 0.8 kg at 1, 2, 4, and 10 years, respectively, were significantly greater than the 1-kg weight loss at 1, 2, and 4 years and 3.5 ± 0.8 kg weight loss at 10 years for the DSE group ( P values ≤ 0.0001). AHI was lower with ILI than DSE by 9.7, 8.0, and 7.9 events/h at 1, 2, and 4 years, respectively ( P values ≤ 0.0004), and 4.0 events/h at 10 years ( P  = 0.109). Change in AHI over time was related to amount of weight loss, baseline AHI, visit year ( P values < 0.0001), and intervention independent of weight change ( P  = 0.01). OSA remission at 10 years was more common with ILI (34.4%) than DSE (22.2%). Conclusions: Participants with OSA and type 2 diabetes mellitus receiving ILI for weight loss had reduced OSA severity at 10 years. No difference in OSA severity was present between ILI and DSE groups at 10 years. Improvement in OSA severity over the 10-year period with ILI was related to change in body weight, baseline AHI, and intervention independent of weight change.

Background: To examine the relationship between early physical activity (PA) adoption (2, 3, and 4 mo) and longer-term PA adherence (1 y) among individuals who were inactive at baseline and received a lifestyle intervention., Methods: Participants (n = 637) received weekly behavioral weight loss sessions, calorie reduction, and PA goals (50-175 min/wk progression). PA was assessed via self-reported measures at baseline, months 2 to 4, and 1 year., Results: PA at months 2 to 4 was significantly correlated with PA at 1 year (rs = .29-.35, P < .01). At all early time points, those failing to meet the prescribed PA goal (early nonadopters) engaged in significantly less PA at 1 year than those meeting the early PA goal (initial adopters). For example, using 2-month criteria, initial adopters engaged in 108.3 minutes per week more at 1 year compared with early nonadopters (P < .01) and had 2.8 times the odds (95% confidence interval, 1.9-4.2) of meeting the 1-year PA goal (≥175 min/wk, P < .01)., Conclusions: Failure to achieve PA goals at 2, 3, or 4 months results in less overall PA at 1 year. Thus, PA observed as early as month 2 may be a useful indicator for identifying at-risk individuals who may benefit from more intensive PA intervention strategies.

Purpose: This study aimed to examine whether long-term fish oil (FO) supplementation is associated with a lower risk of mobility disability and enhances benefits of physical activity (PA)., Methods: A total of 1635 sedentary adults age 70 to 89 yr from the Lifestyle Interventions and Independence for Elders single-blinded randomized, multicenter clinical trial, which compared a structured PA program to a health education program. Primary outcome was incident major mobility disability (MMD), defined by loss of ability to walk 400 m, measured every 6 months for an average of 2.6 yr. Secondary outcomes included persistent mobility disability, Short Physical Performance Battery, 400-m walk speed, and grip strength., Results: A third of participants reported using FO at baseline (456 (28%); mean age, 78.5 yr; 70.5% women). MMD was experienced by 131 participants (28.7%) in the FO group and 405 (34.4%) participants in the nonuser group. After adjusting for confounders, FO supplementation was associated with a lower risk (HR, 0.78; 95% confidence interval (CI), 0.64-0.96) of incident MMD. However, there was no interaction (P = 0.19) between FO supplementation and PA intervention for MMD. For the secondary outcome of persistent mobility disability, the intervention association differed by supplementation (P = 0.002) with PA intervention associations of (HR, 1.36; 95% CI, 0.83-2.23) for users and (HR, 0.61; 95% CI, 0.46-0.81) for nonusers. Changes in physical performance outcomes were not modified by baseline FO supplementation or combination with PA., Conclusions: FO supplementation was associated with a lower risk of MMD in low to moderate functioning older adults. However, supplementation did not enhance the benefit of PA on risk of mobility disability. These results are hypothesis generating and need to be confirmed in randomized trials.

Objective: This study aimed to examine exercise modality during weight loss on change in inflammation among older adults with overweight or obesity and cardiometabolic disease., Methods: A total of 222 older adults with a mean (SD) age of 66.9 (4.7) years and a mean (SD) BMI of 33.5 (3.5) kg/m 2 were randomized to weight loss (WL; n = 68), WL plus aerobic training (WL + AT; n = 79), or WL plus resistance training (WL + RT; n = 75) for 18 months. C-reactive protein (CRP) and interleukin-6 were measured at baseline, 6 months, and 18 months., Results: All groups lost significant weight from baseline to 18 months, with average adjusted changes of -5.5% for WL, -9.0% for WL + AT, and -10.1% for WL + RT. WL + RT and WL + AT lost significantly more weight than WL (P < 0.05). At 18 months, CRP values in WL + RT were significantly lower than WL (2.25 pg/mL vs. 3.38 pg/mL; P = 0.004). The only difference in interleukin-6 was that at 18 months, WL + RT was lower than WL + AT (2.32 pg/mL vs. 2.75 pg/mL; P = 0.03)., Conclusions: The addition of RT during WL was more effective at reducing levels of CRP than WL. Although results were in the expected direction, there was no difference in CRP between WL and WL + AT., (© 2019 The Obesity Society.)

Objective: This study aimed to examine change in bone mineral density (BMD) and trabecular bone score among older adult weight regainers (WR) and weight maintainers (WM)., Methods: Observational data come from 77 older adults (mean age: 67 [SD 5] years; 69% women; 70% white) with obesity (mean BMI: 33.6 [SD  3.7] kg/m 2 ) who lost weight during an 18-month weight loss intervention. Total body mass and body composition, along with regional (total hip, femoral neck, lumbar spine) BMD and trabecular bone score, were measured at baseline, 18 months, and 30 months. WR (n = 36) and WM (n = 41) categories were defined as a ≥ 5% or < 5% weight gain from 18 to 30 months, respectively., Results: Among skeletal indices, only total hip BMD was significantly reduced during the 18-month intervention period in both WRs (-3.9%; 95% CI: -5.8% to -2.0%) and WMs (-2.4%; 95% CI: -4.3% to -0.5%; P = 0.07). After adjustment for relevant baseline covariates and weight change from 0 to 18 months, 30-month change in total hip BMD was -2.6% (95% CI: -4.3% to -0.9%) and -3.9% (95% CI: -5.7% to -2.1%) among WRs and WMs, respectively (P = 0.07)., Conclusions: Loss of hip BMD persists in the year after a weight loss intervention among older adults with obesity, regardless of weight regain status., (© 2019 The Obesity Society.)

Background: The movement profile of older adults with compromised function is unknown, as is the relationship between these profiles and the development of major mobility disability (MMD)-a critical clinical outcome. We first describe the dimensions of movement in older adults with compromised function and then examine whether these dimensions predict the onset of MMD., Methods: Older adults at risk for MMD (N = 1,022, mean age = 78.7 years) were randomized to receive a structured physical activity intervention or health education control. We assessed MMD in 6-month intervals (average follow-up of 2.2 years until incident MMD), with activity assessed at baseline, 6-, 12- and 24-month follow-up via accelerometry., Results: A principal components analysis of 11 accelerometer-derived metrics yielded three components representing lifestyle movement (LM), extended bouts of moderate-to-vigorous physical activity (MVPA), and stationary body posture. LM accounted for the greatest proportion of variance in movement (53%). Within health education, both baseline LM (HR = 0.74; 95% CI 0.62 to 0.88) and moderate-to-vigorous physical activity (HR = 0.69; 95% CI 0.54 to 0.87) were associated with MMD, whereas only LM was associated with MMD within physical activity (HR = 0.74; 95% CI 0.61 to 0.89). There were similar nonlinear relationships present for LM in both physical activity and health education (p < .04), whereby risk for MMD was lower among individuals with higher levels of LM., Conclusions: Both LM and moderate-to-vigorous physical activity should be central in treatment regimens for older adults at risk for MMD., Trial Registration: clinicaltrials.gov Identifier NCT01072500., (© The Author(s) 2019. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Low-grade chronic inflammation, characterized by elevations in plasma Interleukin-6 (IL-6), is an independent risk factor of impaired mobility in older persons. Angiotensin receptor blockers and omega-3 polyunsaturated fatty acids (ω-3) may reduce IL-6 and may potentially improve physical function. To assess the main effects of the angiotensin receptor blocker losartan and ω-3 as fish oil on IL-6 and 400 m walking speed, we conducted the ENRGISE Pilot multicenter randomized clinical trial., Methods: The ENRGISE Pilot enrolled participants between April 2016 and June 2017, who participated for 12 months. Participants were aged ≥70 years with mobility impairment, had IL-6 between 2.5 and 30 pg/mL, and were able to walk 400 m at baseline. Participants were randomized in three strata 2 × 2 factorial to: (i) losartan 50-100 mg/d or placebo (n = 43), (ii) fish oil 1,400-2,800 mg/d or placebo (n = 180), and (iii) with both (n = 66)., Results: Two hundred eighty-nine participants were randomized (mean age 78.3 years, 47.4% women, 17.0% black). There was no effect of losartan (difference of means = -0.065 ± 0.116 [SE], 95% confidence interval [CI]: -0.293-0.163, p = .58) or fish oil (-0.020 ± 0.077, 95% CI: -0.171-0.132, p = .80) on the log of IL-6. Similarly, there was no effect of losartan (-0.025 ± 0.026, 95% CI: -0.076-0.026, p = .34) or fish oil (0.010 ± 0.017, 95% CI: -0.025-0.044, p = .58) on walking speed (m/s)., Conclusions: These results do not support the use of these interventions to prevent mobility loss in older adults at risk of disability with low-grade chronic inflammation., Registration: Clinicaltrials.gov NCT02676466., (© The Author(s) 2018. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

The objective of this study was to determine the ability of either aerobic or resistance training to counter weight-loss-associated bone loss in older adults. There were 187 older adults (67 years, 70% women, 64% white) with obesity (BMI = 34.5 ± 3.7 kg/m 2 ) and cardiovascular disease and/or metabolic syndrome who were randomized to participate in an 18-month, community-based trial, with a follow-up assessment at 30 months. Intervention arms included: weight loss alone (WL; 7% to 10% baseline weight), WL plus aerobic training (WL + AT), and WL plus resistance training (WL + RT), as well as DXA-acquired total hip, femoral neck, and lumbar spine areal bone mineral density (aBMD), and trabecular bone score (TBS). Biomarkers of bone turnover (procollagen type 1 N-terminal propeptide, C-terminal telopeptide of type 1 collagen) were measured at baseline, 6, 18, and 30 (aBMD and TBS only) months. CT-acquired hip and spine volumetric BMD (vBMD), cortical thickness, and bone strength were measured in a subset at baseline (n = 55) and 18 months. Total hip aBMD was reduced by 2% in all groups at 18 months, with a primary analysis showing no significant treatment effects for any DXA, biomarker, or CT outcome. After adjustment for WL and follow-up at 30 months, secondary analyses revealed that total hip [-0.018 (-0.023 to -0.012) g/cm 2 versus -0.025 (-0.031 to -0.019) g/cm 2 ; p = 0.05] and femoral neck [-0.01 (-0.009 to 0.008) g/cm 2 versus -0.011 (-0.020 to -0.002) g/cm 2 ; p = 0.06] aBMD estimates were modestly attenuated in the WL + RT group compared with the WL group. Additionally, lumbar spine aBMD was increased in the WL [0.015 (0.007 to 0.024) g/cm 2 ] and the WL + RT [0.009 (0.000 to 0.017) g/cm 2 ] groups compared with the WL + AT [-0.003 (-0.012 to 0.005)g/cm 2 ] group; both p ≤ 0.01. Community-based exercise does not prevent bone loss during active WL in older adults; however, adding RT may help minimize long-term hip bone loss. © 2018 American Society for Bone and Mineral Research., (© 2018 American Society for Bone and Mineral Research.)

This article compared the effect of dietary weight loss administered alone (WL) or in combination with aerobic training (WL + AT) or resistance training (WL + RT) on health related quality of life, walking self-efficacy, stair climb self-efficacy, and satisfaction with physical function in older adults with cardiovascular disease or the metabolic syndrome. Participants (N = 249; M age  = 66.9) engaged in baseline assessments and were randomly assigned to one of three interventions, each including a 6-month intensive phase and a 12-month follow-up. Those in WL + AT and WL + RT engaged in 4 days of exercise training weekly. All participants engaged in weekly group behavioral weight loss sessions with a goal of 7-10% reduction in body weight. Participants in WL + AT and WL + RT reported better quality of life and satisfaction with physical function at 6- and 18-months relative to WL. At month 6, WL + AT reported greater walking self-efficacy relative to WL + RT and WL, and maintained higher scores compared to WL at month 18. WL + AT and WL + RT reported greater stair climbing efficacy at month 6, and WL + RT remained significantly greater than WL at month 18. The addition of either AT or RT to WL differentially improved HRQOL and key psychosocial outcomes associated with maintenance of physical activity and weight loss. This underscores the important role of exercise in WL for older adults, and suggests health care providers should give careful consideration to exercise mode when designing interventions.

Background: An important decision with accelerometry is the threshold in counts per minute (CPM) used to define moderate to vigorous physical activity (MVPA). We explore the ability of different thresholds to track changes in MVPA due to a physical activity (PA) intervention among older adults with compromised function: 760 CPM, 1,041 CPM, and an individualized threshold. We also evaluate the ability of change in accelerometry and self-reported PA to attenuate treatment effects on major mobility disability (MMD)., Methods: Data from a week of hip worn accelerometers and self-reported PA data (30-day recall) were examined from baseline, 6-, 12-, and 24-months of follow-up on 1,528 older adults. Participants were randomized to either PA or Health Education (HE). MMD was objectively defined by loss of ability to walk 400 m during the follow-up., Results: The three thresholds yielded similar and higher levels of MVPA for PA than HE (p < .001), however, this difference was significantly attenuated in participants with lower levels of physical function. Self-reported PA that captured both walking and strength training totally attenuated the intervention effect for MMD, an 18% reduction to a 3% increase. Accelerometer CPMs showed less attenuation of the intervention effect., Conclusions: Accelerometry assessment within the LIFE study was not sensitive to change in level in physical activity for older adults with very low levels of physical function. A combination of self-report and objective measures are recommended for use in physical activity intervention studies of the elderly; limitations of accelerometry deserve closer attention.

Background/aims: Clinical trials of older adults are increasingly common, but risks of serious adverse events (SAE) may vary. We describe the incidence of SAE in two randomized trials, one community-based and one nursing home-based., Methods: We performed a secondary data analysis from two randomized clinical trials at one academic health center and 21 nursing homes involving 200 sedentary community dwellers aged 70-89 years and 185 female nursing home residents aged 65 years or older. Interventions included structured physical activity to reduce mobility disability in the Lifestyle Interventions and Independence for Elders (LIFE) study and oral cranberry capsules to reduce bacteriuria plus pyuria in nursing home residents (CRANNY) trial. We measured SAE incidence per 100 person-years and incidence of protocol-related unanticipated SAE per 100 person-years in LIFE and CRANNY trials., Results: Mean age and proportion of patients with dementia in LIFE and CRANNY trials were 79.3 years and 86.4 years and 0% and 78%, respectively. There were 179 total SAE in LIFE including 8 (4%) deaths, and 116 total SAE in CRANNY including 33 (28%) deaths. SAE incidence was 33.7 (95% CI 27.2, 41.8) events per 100 person-years in LIFE and 69.4 (95% CI 49.1, 98.1) events per 100 person-years in CRANNY. No protocol-related unanticipated SAE occurred in either trial., Conclusions: The frequency and severity of SAE vary in older adults. While SAE are common in nursing home residents, protocol-related, unanticipated SAE are rare in nursing home residents and community dwellers. This finding can inform trial monitoring protocols., Trial Registration: ClinicalTrials.gov identifiers: NCT01072500 and NCT01691430.

Objective: To examine the long-term effects of exercise modality during weight loss on body composition and associations between body composition and physical function changes., Methods: Two hundred forty-nine older adults (66.9 ± 4.7 years, 71% women, 32% African American, BMI: 34.4 ± 3.7 kg/m 2 ) were randomized to weight loss (WL; n = 82), WL plus aerobic training (WL + AT; n = 86), or WL plus resistance training (WL + RT; n = 81) for 18 months. Dual-energy x-ray absorptiometry-acquired body composition, 400-m walk time, and knee extensor strength were measured at baseline and at 6 and 18 months., Results: Total body mass loss was enhanced when WL was combined with exercise (WL: -5.7 ± 0.7 kg, WL + AT: -8.5 ± 0.7 kg, WL + RT: -8.7 ± 0.7 kg; P < 0.01). Total body fat mass loss was significantly greater in WL + AT (-6.8 ± 0.6 kg, -16.4%) and WL + RT (-7.8 ± 0.5 kg, -19.0%) than WL (-4.8 ± 0.6 kg, -10.9%); both P < 0.01. Lean mass loss was greatest in WL + AT (-1.6 ± 0.3 kg, -3.1%) compared with WL + RT (-0.8 ± 0.3 kg, -1.5%) or WL (-1.0 ± 0.3 kg; -2.0%); both P ≤ 0.02. Change in 400-m walk time was associated with change in fat mass (β/SD = +6.1 s; P < 0.01), while change in knee extensor strength was associated with change in lean mass (β/SD = +1.6 Nm; P < 0.01)., Conclusions: WL + RT results in less lean mass lost than WL + AT; WL plus exercise yields greater fat mass loss than WL alone., (© 2017 The Obesity Society.)

Background: Among older, overweight, and obese adults with either cardiovascular disease or the metabolic syndrome, reduced mobility and loss of leg strength are important risk factors for morbidity, disability, and mortality. It is unclear whether community-based approaches to weight loss may be an effective solution to this public health challenge., Methods: An 18-month three-site, randomized controlled trial conducted by YMCA staff, with blinded assessors, enrolled 249 older, overweight, and obese adults with either cardiovascular disease or metabolic syndrome with randomization to three interventions: weight loss alone (WL), weight loss + aerobic training (WL + AT), and weight loss + resistance training (WT + RT). The dual primary outcomes were 400-m walk time in seconds and knee extensor strength in Newton meters., Results: All groups lost weight from baseline: average baseline adjusted change of -6.1% (95% confidence interval [CI]: -7.5 to -4.7) for WL only, -8.6% (95% CI: -10.0 to -7.2) for WL + AT, and -9.7% (95% CI: -11.1 to -8.4) for WL + RT. Combined, the two physical activity + WL training groups had greater improvement in walk time than WL alone (mean difference 16.9 seconds [95% CI: 9.7 to 24.0], p < .0001). Baseline adjusted change in knee extensor strength was no greater with WL + RT than WL + AT (mean difference -3.6 Nm [95% CI: -7.5 to 0.3], p = .07)., Conclusions: At risk, older, overweight and obese adults can achieve clinically significant reductions in body weight with community-based weight loss programs. The change in percent weight loss and improvements in mobility are significantly enhanced when either RT or AT is combined with dietary WL., (© The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Objectives: We examined whether multiple domains of baseline cognitive performance were associated with prospective physical activity (PA) adherence in the Lifestyle Interventions and Independence for Elders Pilot study (LIFE-P)., Design, Setting, Participants: The LIFE-P study was a single-blind, multicenter, randomized controlled trial of a PA intervention compared to a successful aging educational intervention in sedentary, mobility-limited older adults., Intervention: A 12-month structured, moderate-intensity, multi-modal PA program that included walking, resistance training, and flexibility exercises. For the first 2 months (adoption), 3 center-based exercise sessions (40-60 min) / week were conducted. During the next 4 months (transition), center-based sessions were conducted 2 times / week. The subsequent maintenance phase consisted of optional once-to-twice-per-week center-based sessions and home-based PA., Measurements: Tests of executive and global cognitive functioning, working memory and psychomotor speed were administered at baseline. Median test scores were used to dichotomize participants into low or high cognitive performance groups., Results: 52 mobility-limited older adults (age: 76.9 ±5 yrs) were randomized to the PA arm of LIFE-P. Compared to participants with high cognitive performance, participants with low performance had similar PA adherence rates (all P ≥ 0.34). Furthermore, weak and non-significant univariate relationships were elicited between all measures of cognition and overall PA adherence levels (r values ranged: -0.20 to 0.12, P ≥ 0.12)., Conclusion: These data suggest that cognitive performance does not limit long-term PA adherence in mobility-limited older adults. Additional studies in larger cohorts are warranted to verify these findings.

Objectives: To determine whether moderate-intensity physical activity (PA) and health education (HE) are differentially associated with categories of hospitalizations or subgroups of participants., Design: Multicenter randomized controlled trial in which participants were randomized to a PA or HE program for an average of 2.6 years., Setting: Eight field centers., Participants: Sedentary men and women aged 70-89 with lower extremity physical limitations but able to walk 400-m in 15 minutes or less (N = 1,635)., Interventions: Structured, moderate-intensity PA (n =  818) at a center (2×/wk) and at home (3-4×/wk) that included aerobic, strength, balance, and flexibility training or HE (n =  817) of educational workshops and upper extremity stretching exercises., Measurements: All-cause inpatient hospitalizations ascertained at 6-month intervals., Results: There were 1,458 hospitalizations (49.1% of PA, 44.4% of HE; risk difference = 4.68%, 95% confidence interval (CI) = -0.18-9.54; hazard ratio (HR) = 1.16, 95% CI = 1.00-1.34). The intervention effect on incident hospitalization did not differ according to race, sex, Short Physical Performance Battery score, age, or history of cardiovascular disease or diabetes mellitus. PA was associated with higher rates of hospitalization in the middle baseline gait speed category, than HE (<0.8 m/s: HR = 0.93, 95% CI = 0.76-1.14; 0.8-1.0 m/s: HR = 1.54, 95% CI = 1.23-1.94; >1.0 m/s: HR = 1.05, 95% CI = 0.67-1.65; interaction P = .005)., Conclusion: A PA program in older adults at risk for mobility disability did not lead to a different risk of specific types of hospitalizations than a HE program overall. Baseline gait speed may be a marker for risk of hospitalization during a PA intervention, because individuals with moderate baseline gait speed in the PA group had slightly higher rates of hospitalization than those in the HE group., Trial Registration: ClinicalTrials.gov identifier: NCT01072500., (© 2016, Copyright the Authors Journal compilation © 2016, The American Geriatrics Society.)

Objective: To test whether a long term, structured physical activity program compared with a health education program reduces the risk of serious fall injuries among sedentary older people with functional limitations., Design: Multicenter, single blinded randomized trial (Lifestyle Interventions and Independence for Elders (LIFE) study)., Setting: Eight centers across the United States, February 2010 to December 2011., Participants: 1635 sedentary adults aged 70-89 years with functional limitations, defined as a short physical performance battery score ≤ 9, but who were able to walk 400 m., Interventions: A permuted block algorithm stratified by field center and sex was used to allocate interventions. Participants were randomized to a structured, moderate intensity physical activity program (n=818) conducted in a center (twice a week) and at home (3-4 times a week) that included aerobic, strength, flexibility, and balance training activities, or to a health education program (n=817) consisting of workshops on topics relevant to older people and upper extremity stretching exercises., Main Outcome Measures: Serious fall injuries, defined as a fall that resulted in a clinical, non-vertebral fracture or that led to a hospital admission for another serious injury, was a prespecified secondary outcome in the LIFE Study. Outcomes were assessed every six months for up to 42 months by staff masked to intervention assignment. All participants were included in the analysis., Results: Over a median follow-up of 2.6 years, a serious fall injury was experienced by 75 (9.2%) participants in the physical activity group and 84 (10.3%) in the health education group (hazard ratio 0.90, 95% confidence interval 0.66 to 1.23; P=0.52). These results were consistent across several subgroups, including sex. However, in analyses that were not prespecified, sex specific differences were observed for rates of all serious fall injuries (rate ratio 0.54, 95% confidence interval 0.31 to 0.95 in men; 1.07, 0.75 to 1.53 in women; P=0.043 for interaction), fall related fractures (0.47, 0.25 to 0.86 in men; 1.12, 0.77 to 1.64 in women; P=0.017 for interaction), and fall related hospital admissions (0.41, 0.19 to 0.89 in men; 1.10, 0.65 to 1.88 in women; P=0.039 for interaction)., Conclusions: In this trial, which was underpowered to detect small, but possibly important reductions in serious fall injuries, a structured physical activity program compared with a health education program did not reduce the risk of serious fall injuries among sedentary older people with functional limitations. These null results were accompanied by suggestive evidence that the physical activity program may reduce the rate of fall related fractures and hospital admissions in men.Trial registration ClinicalsTrials.gov NCT01072500., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Objective: It is unclear whether an intensive program of weight loss combined with exercise prevents the onset of knee pain among those at high risk. We examined whether an intensive lifestyle intervention (ILI) prevents incident knee pain compared with a diabetes mellitus support and education (DSE) comparison group among overweight adults with diabetes mellitus., Methods: We conducted a secondary analysis of the Action for Health in Diabetes (Look AHEAD) study, which is a randomized intervention trial of adults who were obese and had type 2 diabetes mellitus starting in 2001. We studied a subcohort of 2,889 subjects who reported no knee pain at baseline but were at high risk due to obesity. Risk ratios (RRs) were calculated to examine the association of ILI versus DSE with incident knee pain at year 1 and year 4. All analyses were adjusted for potential confounders., Results: Age, sex, and body mass index were similar among ILI and DSE participants with no knee pain at baseline. At year 1, ILI participants were 15% less likely to develop knee pain compared with DSE participants (RR 0.85, 95% confidence interval 0.74-0.98). At year 4, this difference decreased to 5% and was no longer statistically significant., Conclusion: An ILI of diet and exercise may prevent the development of knee pain among those at high risk in the short term. Health care providers may consider recommending diet and exercise as a means to prevent the development of knee pain among those at high risk., (© 2015, American College of Rheumatology.)

Objective: To determine the effects of an intensive lifestyle intervention versus a comparison group on body composition in obese or overweight persons with type 2 diabetes at baseline and at 1, 4, and 8 years., Methods: Body composition was measured by dual-energy X-ray absorptiometry in a subset of 1019 Look AHEAD study volunteers randomized to intervention or comparison groups. The intervention was designed to achieve and maintain ≥7% weight loss through increased physical activity and reduced caloric intake. The comparison group received social support and diabetes education., Results: At 1 year, the intervention group lost fat (5.6 ± 0.2 kg) and lean mass (2.3 ± 0.1 kg) but regained fat (∼100%) and lost lean mass between years 1 and 8. Between baseline and year 8, weight loss was greater in intervention versus comparison groups (4.0 ± 0.4 vs. 2.3 ± 0.4 kg); comparison group weight loss was mostly lean mass (2.1 ± 0.17 kg). Fat mass in the intervention group was lower than that of the comparison group at all post-baseline time points., Conclusions: Reduced fat mass may place the intervention group at a lower risk of obesity-linked sequelae, a hypothesis that can be tested by future studies of this cohort., (© 2015 The Obesity Society.)

Objective: To identify baseline attributes associated with consecutively missed data collection visits during the first 48 months of Look AHEAD—a randomized, controlled trial in 5,145 overweight/obese adults with type 2 diabetes designed to determine the long-term health benefits of weight loss achieved by lifestyle change., Design and Methods: The analyzed sample consisted of 5,016 participants who were alive at month 48 and enrolled at Look AHEAD sites. Demographic, baseline behavior, psychosocial factors, and treatment randomization were included as predictors of missed consecutive visits in proportional hazard models., Results: In multivariate Cox proportional hazard models, baseline attributes of participants who missed consecutive visits (n 5 222) included: younger age (hazard ratio [HR] 1.18 per 5 years younger; 95% confidence Interval 1.05, 1.30), higher depression score (HR 1.04; 1.01, 1.06), non-married status (HR 1.37; 1.04, 1.82), never self-weighing prior to enrollment (HR 2.01; 1.25, 3.23), and randomization to minimal vs. intensive lifestyle intervention (HR 1.46; 1.11, 1.91)., Conclusions: Younger age, symptoms of depression, non-married status, never self-weighing, and randomization to minimal intervention were associated with a higher likelihood of missing consecutive data collection visits, even in a high-retention trial like Look AHEAD. Whether modifications to screening or retention efforts targeted to these attributes might enhance long-term retention in behavioral trials requires further investigation.

Unlabelled: The importance of physical activity in weight management is widely documented. Although accelerometers offer an objective measure of activity that provide a valuable tool for intervention research, considerations for processing these data need further development., Objective: This study tests the effects of using different criteria for accelerometry data reduction., Design and Methods: Data were obtained from 2,240 overweight and obese individuals with type 2 diabetes mellitus (T2DM) from the Look AHEAD study, with 2,177 baseline accelerometer files used for analysis. Number, duration, and intensity of moderate (≥ 3 metabolic equivalents (METS)) and vigorous (≥ 6 METS) activity bouts were compared using various data reduction criteria. Daily wear time was identified as 1,440 min/day minus non-wear time. Comparisons of physical activity patterns for non-wear time (using either 20, 30, or 60 min of continuous zeros), minimal daily wear time (8, 10, and 12 h), number of days with available data (4, 5, and 6 days), weekdays vs. weekends, and 1- or 2-min time interruptions in an activity bout were performed., Results: In this mostly obese population with T2DM (BMI = 36.4 kg/m(2) ; mean age = 59.0 years), there were minimal differences in physical activity patterns using the different methods of data reduction. Altering criteria led to differences in the number of available data (sample size) meeting specific criteria., Conclusions: Although our results are likely directly applicable only to obese individuals with T2DM, an understudied population with regards to physical activity, the systematic analysis for data reduction employed can be more generalizable and provide guidance in this area in the absence of standard procedures., (Copyright © 2012 The Obesity Society.)

Depressed individuals are frequently excluded from weight loss trials because of fears that weight reduction may precipitate mood disorders, as well as concerns that depressed participants will not lose weight satisfactorily. The present study examined participants in the Look AHEAD study to determine whether moderate weight loss would be associated with incident symptoms of depression and suicidal ideation, and whether symptoms of depression at baseline would limit weight loss at 1 year. Overweight/obese adults with type 2 diabetes (n = 5,145) were randomly assigned to an Intensive Lifestyle Intervention (ILI) or a usual care group, Diabetes Support and Education (DSE). Of these, 5,129 participants completed the Beck Depression Inventory (BDI) and had their weight measured at baseline and 1 year. Potentially significant symptoms of depression were defined by a BDI score ≥10. Participants in ILI lost 8.6 ± 6.9% of initial weight at 1 year, compared to 0.7 ± 4.8% for DSE (P < 0.001, effect size = 1.33), and had a reduction of 1.4 ± 4.7 points on the BDI, compared to 0.4 ± 4.5 for DSE (P < 0.001, effect size = 0.23). At 1 year, the incidence of potentially significant symptoms of depression was significantly lower in the ILI than DSE group (6.3% vs. 9.6%) (relative risk (RR) = 0.66, 95% confidence interval (CI) = 0.5, 0.8; P < 0.001). In the ILI group, participants with and without symptoms of depression lost 7.8 ± 6.7% and 8.7 ± 6.9%, respectively, a difference not considered clinically meaningful. Intentional weight loss was not associated with the precipitation of symptoms of depression, but instead appeared to protect against this occurrence. Mild (or greater) symptoms of depression at baseline did not prevent overweight/obese individuals with type 2 diabetes from achieving significant weight loss.

Background: There is a lack of information on whether exercise training alone can reduce the prevalence of metabolic syndrome (MetS) in elderly men and women., Methods: This study was an ancillary to the Lifestyle Interventions and Independence for Elders Pilot Study, a four-site, single-blind, randomized controlled clinical trial comparing a 12-month physical activity (PA) intervention (N = 180) with a successful aging intervention (N = 181) in elderly (70-89 years) community-dwelling men and women at risk for physical disability. The PA intervention included aerobic, strength, and flexibility exercises, with walking as the primary mode. MetS was defined using the National Cholesterol Education Program criteria., Results: There was no significant change in body weight or fat mass after either intervention. The trend of MetS prevalence over the intervention period was similar between PA and successful aging groups (p = .77). Overall, the prevalence of MetS decreased significantly from baseline to 6 months (p = .003) but did not change further from 6- to 12-month visits (p = .11). There were no group differences in any individual MetS components (p > .05 for all group by visit interactions). However, in individuals not using medications at any visit to treat MetS components, those in the PA intervention had lower odds of having MetS than those in the successful aging group during follow-up (odds ratio = 0.28, 95% confidence interval = 0.08-0.96)., Conclusions: In this sample, a 12-month PA intervention did not reduce the prevalence of MetS more than a successful aging intervention, perhaps due to the large proportion of individuals taking medications for treating MetS components.

Intentional weight loss is an important component of treatment for overweight patients with type 2 diabetes, but the effects on bone density are not known. We used data from the Look AHEAD trial to determine the impact of an intensive lifestyle weight loss intervention (ILI) compared with diabetes support and education (DSE) on changes in bone mineral density (BMD) over 12 months. Overweight and obese adults with type 2 diabetes were randomly assigned to ILI or DSE. In a substudy of BMD conducted at 5 of 16 clinical centers, hip, spine, and whole body dual X-ray absorptiometry scans were obtained at baseline and 1-year later on 642 of 739 ILI and 632 of 740 DSE participants. At baseline, mean age was 58.4 years, and average body mass index was 35.2 kg/m(2). Total hip BMD T-score was <-2.5 in 1% and <-1.0 in 8%. At 1 year, weight loss was greater in ILI than DSE (-8.6% versus -0.7%), and glycemic control and fitness were also improved. Bone loss over 1 year was greater in ILI at the total hip (-1.4% versus -0.4%; p < 0.001) and femoral neck (-1.5% versus -0.8%; p = 0.009), but change in BMD for the lumbar spine and whole body did not differ between groups. In ILI, bone loss at the total hip was independently associated with weight loss in men and women and with poorer glycemic control in men, but was not associated with changes in fitness. One year of an intensive lifestyle intervention in adults with type 2 diabetes, resulting in weight loss, was associated with a modest increase in hip bone loss despite improved fitness and glycemic control., (Copyright © 2012 American Society for Bone and Mineral Research.)

Objectives: To determine whether the presence of high depressive symptoms (Center for Epidemiologic Studies Depression Scale (CES-D) score ≥ 14) diminished physical performance benefits after a comprehensive physical activity intervention in older adults., Design: A post hoc analysis of data from the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) study, a single-blind randomized controlled trial comparing a moderate-intensity physical activity intervention (PA) with a successful aging control (SA)., Setting: Multicenter U.S. institutions participating in the LIFE-P trial., Participants: Four hundred twenty-four sedentary, noninstitutionalized adults aged 70 to 89., Measurements: Depressive symptoms were assessed using the CES-D. Physical performance tests included the Short Physical Performance Battery (SPPB) and 400-m walk time (400 mw) at baseline and 6 and 12 months., Results: Of the participants, 15.8% had high depressive symptom scores (CES-D ≥ 14). For participants with low depressive symptoms, SPPB scores improved more in the PA than the SA group over 12 months (adjusted score difference +0.70; P < .001 at 6 months and +0.58; P = .004 at 12 months), and 400 mw times improved in the PA group at 6 months (adjusted score difference -0.41 minutes; P = .02). For participants with high depressive symptoms, the difference in improvement fell short of statistical significance on the SPPB between the PA and SA groups (adjusted score difference +0.76 (P = .18) at 6 months and +0.94 (P = .12) at 12 months)., Conclusion: The presence of high depressive symptoms did not substantially diminish physical performance benefits realized after a PA intervention in sedentary older adults., (© 2011, Copyright the Authors. Journal compilation © 2011, The American Geriatrics Society.)

Lifestyle interventions have resulted in weight loss or improved physical fitness among individuals with obesity, which may lead to improved physical function. This prospective investigation involved participants in the Action for Health in Diabetes (Look AHEAD) trial who reported knee pain at baseline (n = 2,203). The purposes of this investigation were to determine whether an Intensive Lifestyle Intervention (ILI) condition resulted in improvement in self-reported physical function from baseline to 12 months vs. a Diabetes Support and Education (DSE) condition, and whether changes in weight or fitness mediated the effect of the ILI. Outcome measures included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and physical function subscales, and WOMAC summary score. ILI participants exhibited greater adjusted mean weight loss (s.e.) vs. DSE participants (-9.02 kg (0.48) vs. -0.78 kg (0.49); P < 0.001)). ILI participants also demonstrated more favorable change in WOMAC summary scores vs. DSE participants (β (s.e.) = -1.81 (0.63); P = 0.004). Multiple regression mediation analyses revealed that weight loss was a mediator of the effect of the ILI intervention on change in WOMAC pain, function, and summary scores (P < 0.001). In separate analyses, increased fitness also mediated the effect of the ILI intervention upon WOMAC summary score (P < 0.001). The ILI condition resulted in significant improvement in physical function among overweight and obese adults with diabetes and knee pain. The ILI condition also resulted in significant weight loss and improved fitness, which are possible mechanisms through which the ILI condition improved physical function.

Purpose: This study describes baseline physical activity (PA) patterns of individuals with type 2 diabetes mellitus (T2DM) enrolled in the multicenter Look AHEAD Study using an objective measure of PA (accelerometry)., Methods: A total of 2240 participants (age = 59.0 ± 6.8 yr and body mass index (BMI) = 36.5 ± 6.0 kg·m−²) with T2DM provided data for this substudy. Participants were instructed to wear an accelerometer during waking hours for 7 d. Accelerometry data were analyzed to identify periods meeting the criteria of ≥3 MET·min−¹ for Q10 min(moderate- to vigorous-intensity PA (MVPA)) and ≥6 MET·min−¹ for ≥10 min (vigorous-intensity PA (VPA)). Self-reported PA was also assessed with a questionnaire. Accelerometry and self-reported PA data were compared across categories of BMI, sex, race, age, fitness, diabetes medication usage, and history of cardiovascular disease., Results: Self-reported PA was lower at higher levels of BMI, was higher in males, was lowest for African-American/black, and was positively associated with fitness. Multivariate analyses for accelerometer-measured MVPA and VPA showed that more PA bouts per day, minutes per bout, METs per minute, and MET-minutes were associated with higher fitness. For MVPA, bouts per day were higher in men, and METs per minute were higher in women. For VPA, bouts per day was positively associated with increasing age and differed by race/ethnicity. METs per minute were significantly lower at higher levels of BMI and in women. Diabetes medication usage and history of cardiovascular disease were not associated with patterns of PA examined., Conclusions: Results provide information on factors that contribute to PA patterns in adults with T2DM when PA is assessed using both objective and subjective measures. These data may inform interventions to improve PA in adults with T2DM

Objectives: To determine whether participation in usual moderate-intensity or more-vigorous physical activity (MVPA) is associated with physical function performance and to identify sociodemographic, psychosocial, and disease-related covariates that may also compromise physical function performance., Design: Cross-sectional analysis of baseline variables of a randomized controlled intervention trial., Setting: Four academic research centers., Participants: Four hundred twenty-four older adults aged 70 to 89 at risk for mobility disability (scoring <10 on the Short Physical Performance Battery (SPPB)) and able to complete the 400-m walk test within 15 minutes., Measurements: Minutes of MVPA (dichotomized according to above or below 150 min/wk of MVPA) assessed according to the Community Healthy Activities Model Program for Seniors questionnaire, SPPB score, 400-m walk test, sex, body mass index (BMI), depressive symptoms, age, and number of medications., Results: The SPPB summary score was associated with minutes of MVPA (ρ=0.16, P=.001). In multiple regression analyses, age, minutes of MVPA, number of medications, and depressive symptoms were associated with performance on the composite SPPB (P<.05). There was an association between 400-m walk time and minutes of MVPA (ρ=-0.18; P<.001). In multiple regression analyses, age, sex, minutes of MVPA, BMI, and number of medications were associated with performance on the 400-m walk test (P<.05)., Conclusion: Minutes of MVPA, sex, BMI, depressive symptoms, age, and number of medications are associated with physical function performance and should all be taken into consideration in the prevention of mobility disability., (© 2010, Copyright the Authors. Journal compilation © 2010, The American Geriatrics Society.)

Background: Little is known about the HIV and sexually transmitted disease (STD) risk behaviors of Hispanic/Latino farmworkers. This study was designed to describe risk factors for HIV and STD infection, explore personal characteristics associated with condom use, and evaluate the feasibility of collecting self-report and biomarker data from farmworkers., Methods: Self-report and biomarker data were collected from a sample of male farmworkers living in 29 camps in North Carolina during the 2008 growing season., Results: Over half of the 100 male workers, mean age 37.1 (range 19-68) years, reported binge drinking during the past 12 months. Forty percent of those who reported having had sex during the past 3 months indicated that they were under the influence of alcohol. Knowledge of HIV and STD transmission and prevention was low. Among the 25 workers who reported having had sex during the past 3 months, 16 and 2 reported using a condom consistently during vaginal and anal sex, respectively, and nearly 1 out of 6 workers reported paying a woman to have sex. Two workers tested positive for syphilis., Conclusions: Farmworkers in this sample demonstrated significant HIV and STD risks; however, when exploring potential bivariate associations with consistent condom use no statistically significant associations were identified perhaps due to the small sample size. Because it was feasible to collect self-report and biomarker data related to HIV and STDs from Hispanic/Latino farmworkers, research needed to further explore risks and develop interventions to reduce disease exposure and transmission among this vulnerable population., (© 2010 Wiley-Liss, Inc.)

Objectives: To examine baseline characteristics and change in gait speed and Short Physical Performance Battery (SPPB) scores in participants medically suspended (MS) from a physical activity intervention (PA)., Design: Randomized controlled trial., Setting: University and community centers., Participants: Sedentary older adults (N = 213) randomized to PA in the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P)., Measurements: MS was defined as missing 3 consecutive PA sessions in adoption and transition phases or 2 wk in maintenance phase because of a health event., Results: In all, 122 participants completed PA without MS (NMS subgroup), 48 participants underwent MS and resumed PA (SR subgroup), and 43 participants underwent MS and did not complete PA (SNR subgroup). At baseline, SNR walked slower (p = .03), took more prescribed medications (p = .02), and had lower SPPB scores than NMS and SR (p = .02). Changes from baseline to Month 12 SPPB scores were affected by suspension status, adjusted mean (SE) SPPB change: SNR 0.0957 (0.3184), SR 0.9413 (0.3063), NMS 1.0720 (0.1871); p = .03., Conclusions: MS participants unable to return to complete the PA in a trial of mobility-limited sedentary older adults had slower walking speeds, lower SPPB scores, and a higher number of prescribed medications at baseline. Change in SPPB scores at 12 months was related to suspension status.

Background: It is well recognized that physical activity (PA) is important for older adults; yet, clinicians remain pessimistic about the ability of older adults with compromised function to adhere to long-term treatment and to maintain behavior change once treatment has been terminated., Methods: We examined the functional status of older adults at a field center (Wake Forest University) 2 years after completing 12 months of treatment in the Lifestyle Interventions and Independence for Elders Pilot study. At baseline, participants were randomized to either a PA or a successful aging (SA) control group. Outcome measures included an interview assessment of PA, the Short Physical Performance Battery (SPPB), and performance on a 400-m self-paced walking test., Results: Two years after the formal intervention had ended, participants who were originally in the PA group continued to engage in more minutes of moderate PA and tended to have better SPPB and walking speed than those in the SA group (effect sizes [ES]: SPPB = 0.40, walking speed = 0.37). Seven (12.7%) participants in the PA group failed the 400-m walk at the 36-month follow-up assessment, whereas this number was 11 (21.6%) in the SA group., Conclusion: Older adults who have compromised physical function are able to sustain some of the benefits derived from participating in structured PA 2 years after supervised treatment has been terminated.

Objectives: To examine the association between stopping to rest during a 400-m usual-pace walk test (400-MWT) and incident mobility disability in older persons with functional limitations., Design: Prospective cohort study., Setting: Community based., Participants: Four hundred twenty-four participants in the Lifestyle Intervention and Independence for Elders Pilot (LIFE-P) Study aged 70 to 89 with functional limitations (summary score < or =9 on the Short Physical Performance Battery (SPPB)) but able to complete the 400-MWT within 15 minutes., Measurements: Rest stops during the 400-MWT were recorded. The onset of mobility disability, defined as being unable to complete the 400-MWT or taking more than 15 minutes to do so, was recorded at Months 6 and 12., Results: Fifty-four (12.7%) participants rested during the 400-MWT at baseline, of whom 37.7% experienced mobility disability during follow-up, versus 8.6% of those not stopping to rest. Performing any rest stop was strongly associated with incident mobility disability at follow-up (odds ratio (OR)=5.4, 95% confidence interval (CI)=2.7-10.9) after adjustment for age, sex, and clinic site. This association was weaker, but remained statistically significant, after further adjusting for SPPB and time to complete the 400-MWT simultaneously (OR=2.6, 95% CI=1.2-5.9)., Conclusion: Stopping to rest during the 400-MWT is strongly associated with incident mobility disability in nondisabled older persons with functional limitations. Given the prognostic value, rest stops should be recorded as part of the standard assessment protocol for the 400-MWT.

Purpose: Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) was a trial to examine the effects of a physical activity intervention (PA) compared with a health education control (SA) on measures of disability risk in sedentary older adults (N = 424). We examined adherence to the LIFE-P PA intervention for the first 12 months of the trial., Methods: The PA intervention consisted of walking, strength, flexibility, and balance training supplemented with behavioral skills training modules, and it used a phased, center-based schedule of adoption (3x wk(-1), weeks 1-8), transition (2x wk(-1), weeks 9-24), and maintenance (1x wk(-1), weeks 25 to end of trial) while transitioning to primarily home-based physical activity. SA consisted of weekly (weeks 1-26) transitioning to monthly health education workshops., Results: Participation in moderate-intensity physical activity increased from baseline to months 6 and 12 in PA compared with SA (P < 0.001). At 12 months, PA participants who reported > or = 150 min x wk(-1) of moderate activity demonstrated a significantly greater improvement in their Short Physical Performance Battery score compared with participants who reported < 150 min.wk of moderate activity (P < 0.017). For the PA arm, center-based attendance was 76.3 +/- 24.5, 65.4 +/- 28.6, and 49.8 +/- 35.8% in the adoption, transition, and maintenance phases, respectively., Conclusions: Adherence to physical activity in LIFE-P was associated with greater improvement in SPPB score and was consistent with adherence in physical activity trials of shorter duration in this subgroup of older adults. Older individuals at risk for disability can adhere to a regular program of physical activity in a long-term randomized trial.

Objectives: To describe several recruitment parameters derived from the Lifestyle Interventions and Independence for Elders pilot (LIFE-P) study for use in a full-scale trial of mobility disability prevention., Design: A description of the recruiting methods and baseline characteristics of a four-site randomized, controlled trial testing the effectiveness of a physical activity intervention at preventing mobility disability., Setting: The Cooper Institute, Dallas, Texas; Stanford University, Stanford, California; University of Pittsburgh, Pittsburgh, Pennsylvania; and Wake Forest University, Winston-Salem, North Carolina., Participants: Community-living persons aged 70 to 89 who were able to walk 400 m within 15 minutes and were at high risk for disability (scoring<10 on the Short Physical Performance Battery (SPPB)) but without comorbidity severe enough to preclude full study participation., Measurements: Measures of efficiency included number of randomized participants per recruitment technique and costs per randomized participant across randomization techniques., Results: The 9-month recruiting period resulted in 3,141 telephone screens, of which 424 (13.5%) participants were randomized (68.9% women, 25.7% minorities, 41.5% with SPPB scores<8). Forty percent of telephone-screened participants were excluded primarily because of regular participation in physical activity, health exclusions, or self-reported mobility disability. Of the 1,252 persons attempting the physical performance assessments, 41% scored above the SPPB cutoff. Of the 566 remaining eligible, 9.9% could not complete the 400-m walk, and another 18.9% had various medical exclusions. Direct mailing was the most productive recruitment strategy (61.6% of all randomized participants). Recruitment cost approximately $439 per randomized participant., Conclusion: The LIFE study achieved all recruitment goals and demonstrated the feasibility of recruiting high-risk community-dwelling older persons for trials of disability prevention in diverse geographic areas.

Objectives: A prospective design was used to examine predictors of adherence to a physical activity intervention in older adults with compromised function., Methods: The sample included 213 men (31.1%) and women (68.9%) with an average age of 76.53 years., Results: The predictor variables accounted for 10% of the variance in percent attendance during adoption and transition, respectively. Adding percent attendance during adoption to the prediction of percent attendance during transition increased the explained variance in this phase to 21%. During maintenance, the predictors accounted for 13% of the variance in frequency of physical activity; this estimate increased to 46% when adding in percent attendance from the transition phase., Discussion: These results are encouraging in that the physical activity intervention appears to have been well tolerated by diverse subgroups of older adults. The role of prior behavior in predicting downstream adherence underscores the importance of developing proactive interventions for treating nonadherence in older adult populations.

The vasoactive effect of angiotensin (Ang)-(1-7) in mesenteric resistance arteries together with its plasma and kidney concentration and urinary excretion was assessed in pregnant and virgin rats. Mesenteric arteries (230-290 microm) were mounted in a pressurized myograph system and Ang-(1-7) concentration-dependent response curves (10(-10)-10(-5) M) were determined in arteries preconstricted with endothelin-1 (10(-7) M). The Ang-(1-7) response was investigated in vessels with and without pretreatment with the Ang-(1-7) antagonist [D-[Ala(7)]-Ang-(1-7)] (10(-7) M). Ang-(1-7) caused a significantly enhanced, concentration-dependent dilation of mesenteric vessels (EC(50) = 2.7 nM) from pregnant compared with virgin female rats. D-[Ala(7)]-Ang-(1-7) eliminated the vasodilator effect of Ang-(1-7). There was no significant change in plasma concentration of Ang-(1-7) in pregnant animals. On the other hand, 24 h urinary excretion and kidney concentration of Ang-(1-7) were significantly higher in pregnant animals. The increased mesenteric dilation to Ang-(1-7) with enhanced kidney concentration and 24 h urinary excretion rate of Ang-(1-7) suggests an important role for this peptide in cardiovascular regulation during pregnancy.

Mesenteric arteries from male Sprague-Dawley rats were mounted in a pressurized myograph system. Ang-(1-7) concentration-dependent responses were determined in arteries preconstricted with endothelin-1 (10(-7)M). The receptor(s) mediating the Ang-(1-7) evoked dilation were investigated by pretreating the mesenteric arteries with specific antagonists of Ang-(1-7), AT(1) or AT(2) receptors. The effects of Ang-(3-8) and Ang-(3-7) were also determined. Ang-(1-7) caused a concentration-dependent dilation (EC(50): 0.95 nM) that was blocked by the selective Ang-(1-7) receptor antagonist D-[Ala(7)]-Ang-(1-7). Administration of a specific antagonist to the AT(2) receptor (PD123319) had no effect. On the other hand, losartan and CV-11974 attenuated the Ang-(1-7) effect. These results demonstrate that Ang-(1-7) elicits potent dilation of mesenteric resistance vessels mediated by a D-[Ala(7)]-Ang-(1-7) sensitive site that is also sensitive to losartan and CV-11974.