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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

Background: Type 2 diabetes mellitus and overweight/obesity increase healthcare costs. Both are also associated with accelerated aging. However, the contributions of this accelerated aging to increased healthcare costs are unknown., Methods: We use data from a 8-year longitudinal cohort followed at 16 U.S. clinical research sites. Participants were adults aged 45-76 years with established type 2 diabetes and overweight or obesity who had enrolled in the Action for Health in Diabetes clinical trial. They were randomly (1:1) assigned to either an intensive lifestyle intervention focused on weight loss versus a comparator of diabetes support and education. A validated deficit accumulation frailty index (FI) was used to characterize biological aging. Discounted annual healthcare costs were estimated using national databases in 2012 dollars. Descriptive characteristics were collected by trained and certified staff., Results: Compared with participants in the lowest tertile (least frail) of baseline FI, those in the highest tertile (most frail) at Year 1 averaged $714 (42%) higher medication costs, $244 (22%) higher outpatient costs, and $800 (134%) higher hospitalization costs (p < 0.001). At Years 4 and 8, relatively greater increases in FI (third vs. first tertile) were associated with an approximate doubling of total healthcare costs (p < 0.001). Mean (95% confidence interval) relative annual savings in healthcare costs associated with randomization to the intensive lifestyle intervention were $437 ($195, $579) per year during Years 1-4 and $461 ($232, $690) per year during Years 1-8. These were attenuated and the 95% confidence interval no longer excluded $0 after adjustment for the annual FI differences from baseline., Conclusions: Deficit accumulation frailty tracks well with healthcare costs among adults with type 2 diabetes and overweight or obesity. It may serve as a useful marker to project healthcare needs and as an intermediate outcome in clinical trials., (© 2024 The American Geriatrics Society.)

Objective: The modified Clinical Test of Sensory Interaction and Balance (mCTSIB) is used to clinically assess vestibular sensory integration (VSI), the process by which the central nervous system integrates vestibular afference to maintain balance. The rate and effects of impaired VSI (IVSI) on prosthetic mobility in people with lower limb amputation (LLA) is unknown. The objective of this study was to use the mCTSIB to classify VSI in active community ambulators with LLA and to examine the relationship between IVSI and prosthetic mobility, as measured by the Component Timed Up and Go (cTUG) test., Methods: This was a cross-sectional study with a convenience sample of 130 community ambulators with unilateral LLA. Classification of VSI was determined based on a time-based pass/fail mCTSIB performance. Participants were classified as having normal sensory integration (NSI) if they could balance for 30 seconds in every mCTSIB condition. Participants who failed condition 4 exclusively were classified as IVSI. Prosthetic mobility, as measured by the cTUG, was compared between NSI and IVSI groups., Results: Of the 130 participants, 29 (22%) were classified as IVSI and 95 (73%) were classified as having NSI. Prosthetic mobility significantly differed between IVSI and NSI groups, with IVSI participants performing all components of the cTUG significantly slower. Medium to large effect sizes were found between groups during cTUG., Conclusions: These results suggest that 1 in 5 community ambulators with LLA have IVSI, with associated limitations in balance confidence and prosthetic mobility., Impact: The ability to integrate vestibular information was found to have a strong relationship with prosthetic mobility in active community ambulators with LLA, especially with performing a 180-degree step turn. Physical therapists can use the mCTSIB to classify sensory integration during prosthetic rehabilitation and develop an appropriate balance intervention., Lay Summary: Active adults with LLA can use information from their senses to maintain their standing balance. Adults with LLA who have difficulty balancing on foam with closed eyes were slower to get in and out of a chair, walk, and perform a 180-degree step turn., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The Enabling Reduction of Low-grade Inflammation in Seniors (ENRGISE) Pilot Study is a multicenter randomized clinical trial examining the feasibility of testing whether omega-3 fish oil (ω-3) and the angiotensin receptor blocker losartan alone or in combination can reduce inflammation and improve walking speed in older adults with mobility impairment. We describe recruitment methods and results., Methods: Eligible participants were 70 years and older, had elevated interleukin-6 levels (2.5-30 pg/mL) and mobility impairment., Results: Of those who responded to recruitment, 83% responded to mailings. A total of 5,424 telephone screens were completed; of these, 2,011 (37.1%) were eligible for further screening. The most common reasons for ineligibility at the telephone screens were lack of mobility impairment or use of angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (n=1.789). Of the 1,305 initial screening visits, 1,087 participants had slow gait speed (<1 m/s). Of these, 701 (64%) had elevated interleukin-6 and were eligible for second screening visits. Of the 582 second screening visits, 335 (57.6%) were eligible to be randomized. A total of 289 participants (96% of goal) were randomized: 180 in the ω-3 stratum (240% of goal); 43 in the losartan (57% of goal), and 66 in the combination (44% of goal). The telephone screen and first screening visit to randomization ratio was 19 to 1 and 4.5 to 1, respectively. The estimated cost of recruitment per randomized participant was $1,782., Conclusion: Recruitment for ω-3 exceeded goals, but goals for the losartan and combination strata were not met due to the high proportion of participants taking angiotensin receptor blockers or angiotensin-converting enzyme inhibitors., (© 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.)

Introduction: Older adults are a rapidly growing segment of the U.S., Population: Mobility problems that lead to further disability can be addressed through physical activity interventions. Quality of life outcome results are reported from a large trial of physical activity for sedentary older adults at risk for mobility disability., Methods: Data were from the Lifestyle Interventions and Independence for Elders study. This multisite RCT compared physical activity to health education among 1,635 randomly assigned sedentary older adults at risk for mobility disability in 2010-2011. Measures included demographics; comorbidity; a timed 400-meter walk; the Short Physical Performance Battery; and the Quality of Well-Being Scale (0-1.0 scale). Baseline and long-term follow-up (2.6 years) health-related quality of life data were collected as a secondary outcome. Multivariate linear regression modeling was used to examine covariates of health-related quality of life over time in 2017., Results: The sample had an overall mean Quality of Well-Being score of 0.613. Both groups declined in quality of life over time, but assignment to the physical activity intervention resulted in a slower decline in health-related quality of life scores (p=0.03). Intervention attendance was associated with higher health-related quality of life for both groups. Baseline characteristics including younger age, fewer comorbid conditions, non-white ethnicity, and faster 400-meter walk times were also associated with higher health-related quality of life over time., Conclusions: Declining mobility measured by physical performance is associated with lower quality of life in sedentary older adults. Physical activity interventions can slow the decline in quality of life, and targeting specific subgroups may enhance the effects of such interventions., (Published by Elsevier Inc.)

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: The study objectives were to identify types of complementary therapy that are most predictive of health outcomes, including functional status, physical health-related quality of life (HRQoL), and mental HRQoL among older adults., Design: This was a prospective study., Settings/location: The study comprised computer-assisted interviews conducted in participants' homes., Subjects: Subjects included 1683 adults aged 55 and older who participated in the 2002 National Health Interview Survey and the 2003 Medical Expenditure Panel Survey., Intervention: None., Outcome Measures: Functional status, physical HRQoL, and mental HRQoL at 1-year follow-up., Results: The use of biologically based therapies predicted better functional status, such that users reported less functional impairment than nonusers (p < 0.01), adjusting for age, gender, race/ethnicity, education, health insurance, household income, and comorbid conditions. Users of manipulative and body-based methods reported less functional impairment (p < 0.05). They also reported better physical and mental health-related quality of life, though these relationships were marginally significant. Other groups of therapies, alternative medical systems, mind-body therapies, and prayer were not predictive of either functional status or HRQoL., Conclusions: Favorable effects were observed among users of biologically based therapies and users of manipulative and body-based methods. Other types of complementary therapy had no effects on health status over a 1-year follow-up period.

Migrant farmworkers are exposed to numerous workplace hazards, with pesticides being a ubiquitous occupational exposure. This analysis describes farmworker experiences of field and camp safety conditions and their safety behaviors, and delineates farmworker characteristics associated with safety conditions and behaviors. Data were collected from 255 migrant farmworkers up to 4 times at monthly intervals during the 2007 agricultural season in eastern North Carolina. Measures assess field safety conditions and camp sanitation required by federal and state regulations. Most of the farmworkers were Latino men from Mexico. About 20% had not received pesticide safety training across the season; many of those who received such training did not understand it. Water for washing was not available for about one-third of the workers; soap and towels were not available for over half. About 20% lived in camps with more than eight workers per showerhead and about 20% lived in camps that failed to meet the standard of 30 or fewer workers per washtub/washing machine. Important predictors of variation included H2A visa status and years of experience. Four themes emerged from the analysis: (1) safety regulations are not consistently met; (2) farmworkers do not always practice safety behaviors; (3) camps become more crowded and less compliant during the middle of the agricultural season; and (4) workers with H2A visas experience better conditions and practice more safety behaviors than do workers who do not have H2A visas. Further research needs to account for social and cultural factors. Regulations should be compared with pesticide metabolite levels to measure their effectiveness. More effort is needed to enforce existing regulations.

Background: The number of older adults living in the United States continues to increase, and recent research has begun to target interventions to older adults who have mobility limitations and are at risk for disability. The objective of this study is to describe and examine correlates of health-related quality of life in this population subgroup using baseline data from a larger intervention study., Methods: The Lifestyle Interventions and Independence for Elders-Pilot study (LIFE-P) was a randomized controlled trial that compared a physical activity intervention to a non-exercise educational intervention among 424 older adults at risk for disability. Baseline data (collected in April-December 2004, analyzed in 2006) included demographics, medical history, the Quality of Well-Being Scale (QWB-SA), a timed 400-m walk, and the Short Physical Performance Battery (SPPB). Descriptive health-related quality of life (HRQOL) data are presented. Hierarchical linear regression models were used to examine correlates of HRQOL., Results: The mean QWB-SA score for the sample was 0.630 on an interval scale ranging from 0.0 (death) to 1.0 (asymptomatic, optimal functioning). The mean of 0.630 is 0.070 lower than a comparison group of healthy older adults. The variables associated with lower HRQOL included white ethnicity, more comorbid conditions, slower 400-m walk times, and lower SPPB balance and chair stand scores., Conclusions: Older adults who are at risk for disability had reduced HRQOL. Surprisingly, however, mobility was a stronger correlate of HRQOL than an index of comorbidity, suggesting that interventions addressing mobility limitations may provide significant health benefits to this population.

Objective: The Look AHEAD (Action for Health in Diabetes) study is a 16-centre randomised clinical trial in overweight and obese individuals with type 2 diabetes, designed to evaluate the long-term effects (up to 11.5 years) of intensive weight loss intervention on the time to incidence of major cardiovascular events., Research Design and Methods: Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals aged 4574 years and body mass index (BMI) > 25 kg/m2 (> 27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomised to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education., Results: The 5,145 participants who were randomised between 2001 and 2004 were 63.3% white, 15.6% African-American, 13.2% Hispanic, 5.0% American Indian and 1.0% Asian-American, which closely paralleled the ethnic distribution of diabetes in the National Health and Nutrition Examination Survey (NHANES) 1999-2000 survey. Their average age at entry was 59+/-6.8 years (mean+/-SD), and 60% were women. There were 31.5% between 4555 years of age, 51.5% were 5665, and 17.0% were 6676 years of age. Some 15.4% of participants were taking insulin at the time of randomisation and 14.0% had a history of cardiovascular disease. More men (21.3%) than women (9.2%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers, compared to 16.2% in the NHANES 1999-2000 survey. Furthermore, 65.0% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36+/-5.9 kg/m2 at baseline, with 83.6% of the men and 86.1% of women having a BMI > 30 kg/m2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/m2., Conclusions: The Look AHEAD study has successfully randomised a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background and will examine the effects of lifestyle intervention on the incidence of major cardiovascular events.

Aim: Previous clinical studies suggest hormone replacement therapy (HRT) alleviates menopausal symptoms and may improve health-related quality of life (HRQL). Most studies on HRT and HRQL were limited in duration (12 months or less) and scope (few and non-standard HRQL measures). The aim of this paper is to assess HRQL in the Estrogen Replacement and Atherosclerosis (ERA) trial., Methods: A subset of women within a randomized, blinded, placebo-controlled secondary prevention trial has been studied in outpatient and community settings at 5 US sites. A total of 246 postmenopausal women with angiographically documented heart disease (mean age 66 years, 83% Caucasian) were enrolled in the ERA trial. Participants received either 0.625 mg/day conjugated equine estrogen only, estrogen plus 2.5 mg/day medroxyprogesterone acetate, or placebo. HRQL was assessed using validated questionnaire instruments at baseline and follow-up (mean 3.2 years of trial). Physical and mental functioning, life satisfaction, depressive symptoms, urinary incontinence, sleep disturbance, and frequency and intensity of physical symptoms were evaluated., Results: In this group of women with established coronary disease, active therapy was not significantly associated with more favorable outcomes for any HRQL. The estrogen-only group reported more urinary incontinence than the placebo group (p<0.05). Analyses restricted to adherent women (those who took > or = 80% of pills) showed a similar pattern of results, showing that the estrogen only group reported significantly higher urinary incontinence compared to placebo (p<0.01)., Conclusion: The hormone replacement regimens in the ERA trial did not improve HRQL of postmenopausal women with heart disease.

Objectives: The study assessed clinical outcomes of closure device use following percutaneous coronary revascularization using current standards of anticoagulation and antiplatelet therapy., Background: Evaluation of the outcomes of patients by use of vascular closure devices during coronary interventions employing current standards of anticoagulation and glycoprotein (GP) IIb/IIIa inhibitor therapy is limited., Methods: We evaluated outcomes of 4,525 consecutive patients who underwent percutaneous coronary intervention between July 1997 and April 2000. All patients received anticoagulation with heparin and GP IIb/IIIa inhibitor therapy with abciximab. The closure method was manual in 1,824 patients, Angioseal in 524 patients and Perclose in 2,177 patients. Procedural and hospital vascular outcomes were evaluated., Results: Closure device success was 97.1% Angioseal and 94.1% Perclose (p < 0.05). Minor vascular complications occurred in 1.8% of manual patients, 1.1% of Angioseal patients and 1.2% of Perclose patients (p = NS); major complications occurred in 1.3% of manual patients, 1.1% of Angioseal patients and 1.0% of Perclose patients (p = NS). Multivariate logistic regression identified only closure device failure as an independent predictor of a vascular complication. In patients with successful closure with a device, minor complications (0.8% vs. 1.8%, p < 0.05) and any complication (1.5% vs. 2.5%, p < 0.05) were reduced compared to manual compression., Conclusions: Arterial closure following coronary interventions using anticoagulation and GP IIb/IIIa inhibitor therapy can be safely and effectively performed, with vascular complication rates similar to or lower than with manual pressure. Additionally, vascular complication rates using GP IIb/IIIa inhibitor therapy regardless of the method of arterial closure are equivalent to or lower than previously published rates of vascular complications.

We studied the molecular mechanisms of apoptosis in the prostate cancer cell line LNCaP and whether overexpression of caspase activity could force this cell line to undergo apoptosis. The inhibitor of phosphomevalonate decarboxylase, sodium phenylacetate, and the protein kinase inhibitor staurosporine induced (a) release of cytochrome c from the mitochondria to the cytosol; (b) reduction in mitochondrial transmembrane potential; (c) proteolytic processing of caspase-3 and -7 but not -2; (d) cleavage of the DEVD substrate and the death substrates poly(ADP-ribose) polymerase and DNA fragmentation factor; and (e) apoptosis. The panspecific inhibitor of caspase activation N-benzyloxycarbonyl-Val-Ala-Asp(OMe)-fluoromethylketone (z-VAD-FMK) prevented all of these events except release of mitochondrial cytochrome c into the cytosol. None of these apoptotic signaling events were elicited by staurosporine or sodium phenylacetate treatment of LNCaP-Bcl-2 cells that overexpress the oncoprotein Bcl-2. Because caspase-7 is activated in every model of apoptosis that we have characterized thus far, we wished to learn whether overexpression of this protease could directly cause apoptosis of LNCaP cells. By using a replication-defective adenovirus, overexpression of caspase-7 protein in both LNCaP and LNCaP-Bcl-2 cells was accompanied by induction of cleavage of the DEVD substrate and TUNEL. These studies have demonstrated that caspase-7 and -3 are critical mediators of apoptosis in LNCaP cells. Caspase-7 was proteolytically activated in every model of apoptosis that we have developed, and the overexpression of it induced apoptosis of LNCaP and LNCaP-Bcl-2 cells. Thus, adenoviral-mediated transfer of caspase-7 may offer a new effective approach for the treatment of prostate cancer.