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This Viewpoint outlines the challenges posed by the COVID-19 pandemic in conducting clinical trials and offers some solutions to those barriers. [ABSTRACT FROM AUTHOR]

This Viewpoint discusses ways the coronavirus pandemic is threatening clinical trial conduct and enrollment, and suggests ways to adapt, including changes to how outcomes data are collected and how interventions are delivered and monitored, to minimize trial disruption, maximize trial benefit, and ensure patient health and safety during the pandemic. [ABSTRACT FROM AUTHOR]

The article presents a study which examined the association of aerobic fitness in older people with several factors including mortality, cardiovascular disease, mobility limitation, and disability. The study, called the Health, Aging, and Body Composition study, selected a group of people between the ages of 70 and 79 and assessed their performance as they walked 400 meters in a corridor. The methods by which the participants were selected is described. A chart listing those who were excluded from the corridor walk and why is presented. Another chart lists the characteristics of the participants. Other charts list event rates and hazard ratios as well as cardiovascular response for the participants. Eight graphs depict percentages of mortality, incident cardiovascular disease, mobility limitation, and mobility disability in men and women.

Studies the relationship between ankle/arm blood pressure index (AAI) and cardiovascular morbidity and mortality in older adults with systolic hypertension. Systolic Hypertension in the Elderly Program; Coronary heart disease mortality; Cardiovascular disease mortality.

Context: Multiple factors contribute to mortality in older adults, but the extent to which subclinical disease and other factors contribute independently to mortality risk is not known.Objective: To determine the disease, functional, and personal characteristics that jointly predict mortality in community-dwelling men and women aged 65 years or older.Design: Prospective population-based cohort study with 5 years of follow-up and a validation cohort of African Americans with 4.25-year follow-up.Setting: Four US communities.Participants: A total of 5201 and 685 men and women aged 65 years or older in the original and African American cohorts, respectively.Main Outcome Measures: Five-year mortality.Results: In the main cohort, 646 deaths (12%) occurred within 5 years. Using Cox proportional hazards models, 20 characteristics (of 78 assessed) were each significantly (P<.05) and independently associated with mortality: increasing age, male sex, income less than $50000 per year, low weight, lack of moderate or vigorous exercise, smoking for more than 50 pack-years, high brachial (>169 mm Hg) and low tibial (< or = 127 mm Hg) systolic blood pressure, diuretic use by those without hypertension or congestive heart failure, elevated fasting glucose level (>7.2 mmol/L [130 mg/dL]), low albumin level (< or = 37 g/L), elevated creatinine level (> or = 106 micromol/L [1.2 mg/dL]), low forced vital capacity (< or = 2.06 mL), aortic stenosis (moderate or severe) and abnormal left ventricular ejection fraction (by echocardiography), major electrocardiographic abnormality, stenosis of internal carotid artery (by ultrasound), congestive heart failure, difficulty in any instrumental activity of daily living, and low cognitive function by Digit Symbol Substitution test score. Neither high-density lipoprotein cholesterol nor low-density lipoprotein cholesterol was associated with mortality. After adjustment for other factors, the association between age and mortality diminished, but the reduction in mortality with female sex persisted. Finally, the risk of mortality was validated in the second cohort; quintiles of risk ranged from 2% to 39% and 0% to 26% for the 2 cohorts.Conclusions: Objective measures of subclinical disease and disease severity were independent and joint predictors of 5-year mortality in older adults, along with male sex, relative poverty, physical activity, smoking, indicators of frailty, and disability. Except for history of congestive heart failure, objective, quantitative measures of disease were better predictors of mortality than was clinical history of disease. [ABSTRACT FROM AUTHOR]

IMPORTANCE In older adults reduced mobility is common and is an independent risk factor for morbidity, hospitalization, disability, and mortality. Limited evidence suggests that physical activity may help prevent mobility disability; however, there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability. OBJECTIVE To test the hypothesis that a long-term structured physical activity program is more effective than a health education program(also referred to as a successful aging program) in reducing the risk of major mobility disability. DESIGN, SETTING, AND PARTICIPANTS The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial that enrolled participants between February 2010 and December 2011, who participated for an average of 2.6 years. Follow-up ended in December 2013. Outcome assessors were blinded to the intervention assignment. Participants were recruited from urban, suburban, and rural communities at 8 centers throughout the United States. We randomized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations, defined as a score on the Short Physical Performance Battery of 9 or below, but were able to walk 400m. INTERVENTIONS Participants were randomized to a structured, moderate-intensity physical activity program(n = 818) conducted in a center (twice/wk) and at home (3-4 times/wk) that included aerobic, resistance, and flexibility training activities or to a health education program (n = 817) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises. MAIN OUTCOMES ANDMEASURES The primary outcome was major mobility disability objectively defined by loss of ability to walk 400m. RESULTS Incident major mobility disability occurred in 30.1% (246 participants) of the physical activity group and 35.5% (290 participants) of the health education group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.98], P = .03). Persistent mobility disability was experienced by 120 participants (14.7%) in the physical activity group and 162 participants (19.8%) in the health education group (HR, 0.72 [95% CI, 0.57-0.91]; P = .006). Serious adverse events were reported by 404 participants (49.4%) in the physical activity group and 373 participants (45.7%) in the health education group (risk ratio, 1.08 [95% CI, 0.98-1.20]). CONCLUSIONS AND RELEVANCE A structured, moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability. These findings suggest mobility benefit from such a program in vulnerable older adults. [ABSTRACT FROM AUTHOR]

Importance: In older adults reduced mobility is common and is an independent risk factor for morbidity, hospitalization, disability, and mortality. Limited evidence suggests that physical activity may help prevent mobility disability; however, there are no definitive clinical trials examining whether physical activity prevents or delays mobility disability.Objective: To test the hypothesis that a long-term structured physical activity program is more effective than a health education program (also referred to as a successful aging program) in reducing the risk of major mobility disability.Design, Setting, and Participants: The Lifestyle Interventions and Independence for Elders (LIFE) study was a multicenter, randomized trial that enrolled participants between February 2010 and December 2011, who participated for an average of 2.6 years. Follow-up ended in December 2013. Outcome assessors were blinded to the intervention assignment. Participants were recruited from urban, suburban, and rural communities at 8 centers throughout the United States. We randomized a volunteer sample of 1635 sedentary men and women aged 70 to 89 years who had physical limitations, defined as a score on the Short Physical Performance Battery of 9 or below, but were able to walk 400 m.Interventions: Participants were randomized to a structured, moderate-intensity physical activity program (n = 818) conducted in a center (twice/wk) and at home (3-4 times/wk) that included aerobic, resistance, and flexibility training activities or to a health education program (n = 817) consisting of workshops on topics relevant to older adults and upper extremity stretching exercises.Main Outcomes and Measures: The primary outcome was major mobility disability objectively defined by loss of ability to walk 400 m.Results: Incident major mobility disability occurred in 30.1% (246 participants) of the physical activity group and 35.5% (290 participants) of the health education group (hazard ratio [HR], 0.82 [95% CI, 0.69-0.98], P = .03).Persistent mobility disability was experienced by 120 participants (14.7%) in the physical activity group and 162 participants (19.8%) in the health education group (HR, 0.72 [95% CI, 0.57-0.91]; P = .006). Serious adverse events were reported by 404 participants (49.4%) in the physical activity group and 373 participants (45.7%) in the health education group (risk ratio, 1.08 [95% CI, 0.98-1.20]).Conclusions and Relevance: A structured, moderate-intensity physical activity program compared with a health education program reduced major mobility disability over 2.6 years among older adults at risk for disability. These findings suggest mobility benefit from such a program in vulnerable older adults.Trial Registration: clinicaltrials.gov Identifier: NCT01072500. [ABSTRACT FROM AUTHOR]

Context: In populations of older adults, prediction of coronary heart disease (CHD) events through traditional risk factors is less accurate than in middle-aged adults. Electrocardiographic (ECG) abnormalities are common in older adults and might be of value for CHD prediction.Objective: To determine whether baseline ECG abnormalities or development of new and persistent ECG abnormalities are associated with increased CHD events.Design, Setting, and Participants: A population-based study of 2192 white and black older adults aged 70 to 79 years from the Health, Aging, and Body Composition Study (Health ABC Study) without known cardiovascular disease. Adjudicated CHD events were collected over 8 years between 1997-1998 and 2006-2007. Baseline and 4-year ECG abnormalities were classified according to the Minnesota Code as major and minor. Using Cox proportional hazards regression models, the addition of ECG abnormalities to traditional risk factors were examined to predict CHD events.Main Outcome Measure: Adjudicated CHD events (acute myocardial infarction [MI], CHD death, and hospitalization for angina or coronary revascularization).Results: At baseline, 276 participants (13%) had minor and 506 (23%) had major ECG abnormalities. During follow-up, 351 participants had CHD events (96 CHD deaths, 101 acute MIs, and 154 hospitalizations for angina or coronary revascularizations). Both baseline minor and major ECG abnormalities were associated with an increased risk of CHD after adjustment for traditional risk factors (17.2 per 1000 person-years among those with no abnormalities; 29.3 per 1000 person-years; hazard ratio [HR], 1.35; 95% CI, 1.02-1.81; for minor abnormalities; and 31.6 per 1000 person-years; HR, 1.51; 95% CI, 1.20-1.90; for major abnormalities). When ECG abnormalities were added to a model containing traditional risk factors alone, 13.6% of intermediate-risk participants with both major and minor ECG abnormalities were correctly reclassified (overall net reclassification improvement [NRI], 7.4%; 95% CI, 3.1%-19.0%; integrated discrimination improvement, 0.99%; 95% CI, 0.32%-2.15%). After 4 years, 208 participants had new and 416 had persistent abnormalities. Both new and persistent ECG abnormalities were associated with an increased risk of subsequent CHD events (HR, 2.01; 95% CI, 1.33-3.02; and HR, 1.66; 95% CI, 1.18-2.34; respectively). When added to the Framingham Risk Score, the NRI was not significant (5.7%; 95% CI, -0.4% to 11.8%).Conclusions: Major and minor ECG abnormalities among older adults were associated with an increased risk of CHD events. Depending on the model, adding ECG abnormalities was associated with improved risk prediction beyond traditional risk factors. [ABSTRACT FROM AUTHOR]

The article provides information on a study which determined whether baseline electrocardiographic (ECG) abnormalities or development of new and persistent ECG abnormalities are associated with increased coronary heart disease (CHD) events. The population-based study enrolled 2,192 white and African American older adults aged 70 to 79 years from health, Aging and Body Composition Study without known cardiovascular disease (CVD). The study then assessed incident CHD events among participants without preexisting CVD at baseline.

The article discusses a study which evaluated the relationship between gait speed and survival in geriatric patients, as well as determined the degree to which gait speed explains variability in survival after accounting for age and sex. The study's design, setting and participants are described. Main outcome measures include survival rates and life expectancy. The study found that survival increased across the full range of gait speeds based on the pooled analysis of individual data from 9 selected cohorts.

The article focuses on a study which examined the risks of coronary heart disease (CHD) and total mortality among adults with subclinical hypothyroidism. The study included 55,287 adults in the U.S., Europe, Australia, Brazil and Japan, who were followed up from 1972 to 2007. Of the total study participants, 3,450 developed subclinical hypothyroidism, while 51,837 had euthyroidism. Study authors found that increased thyroid-stimulating hormone (TSH) concentration increased the risk of CHD and CHD-related mortality. They concluded that patients with subclinical hypothyroidism have higher risk of CHD.

The article provides information on a prospective cohort study which investigated the association between adiposity, changes in adiposity and risk of incident type 2 diabetes in adults 65 years of age and older. Participants were men and women in the Cardiovascular Health Study, conducted between 1989 and 2007. Measures of adiposity were based from anthropometry and bioelectrical impedance data at baseline and anthropometry measured three years after. Main outcome measure was incident diabetes determined based on use of antidiabetic drug or a fasting glucose level of 126 milligram/deciliter or greater. A detailed discussion on the research findings is offered.

Context Physical performance in response to exercise appears to be influenced by the angiotensin-converting enzyme (ACE) insertion (I)/deletion (D) genotype in young adults, but whether this relationship could help explain variation in older individuals’ response to exercise has not been well studied. Objective To determine whether the ACE genotype interacts with significant physical activity to affect the incidence of mobility limitation in well-functioning older adults. Design, Setting, and Participants The Health Aging and Body Composition (Health ABC) Cohort Study, conducted in the metropolitan areas of Memphis, Tenn, and Pittsburgh, Pa. A total of 3075 well-functioning community-dwelling adults aged 70 through 79 years were enrolled from 1997 to 1998 and had a mean of 4.1 years of follow-up. Main Outcome Measure Incident mobility limitation defined as the report of difficulty walking a quarter of a mile (0.4 km) or walking up 10 steps on 2 consecutive semiannual interviews (n = 1204). Results Physically active participants (those reporting expending ≥1000 kcal/wk in exercise, walking, and stair climbing) were less likely to develop mobility limitation regardless of genotype. However, activity level interacted significantly with the ACE genotype (P = .002). In the inactive group, the ACE genotype was not associated with limitation (P = .46). In the active group, those with the II genotype were more likely to develop mobility limitation after adjusting for potential confounders compared with those with ID/DD genotypes (adjusted rate ratio, 1.45, 95% confidence interval, 1.08-1.94). The gene association was especially strong among participants reporting weightlifting. Exploration of possible physiological correlates revealed that among active participants, those with the II genotype had higher percentage of body fat (P = .02) and more intermuscular thigh fat (P = .02) but had similar quadriceps strength as those with ID/DD. Conclusions Among older individuals who exercised, those with the ACE DD or ID genotypes were less likely to develop mobility limitation than those with the II genotype. Regardless of genotype, individuals who exercised were less likely to develop mobility limitation than those who did not exercise. [ABSTRACT FROM AUTHOR]

Context Several studies have reported an association between the metabolic syndrome and cardiovascular disease. Despite an increasing awareness that cardiovascular risk factors increase risk of cognitive decline and dementia, there are few data on the metabolic syndrome and cognition. Objective To determine if the metabolic syndrome is a risk factor for cognitive decline and if this association is modified by inflammation. Design and Setting A 5-year prospective observational study conducted from 1997 to 2002 at community clinics at 2 sites. Participants A total of 2632 black and white elders (mean age, 74 years). Main Outcome Measures Association of the metabolic syndrome (measured using National Cholesterol Education Program guidelines) and high inflammation (defined as above median serum level of interleukin 6 and C-reactive protein) with change in cognition (Modified Mini-Mental State Examination [3MS]) at 3 and 5 years. Cognitive impairment was defined as at least a 5-point decline. Results Compared with those without the metabolic syndrome (n = 1616), elders with the metabolic syndrome (n = 1016) were more likely to have cognitive impairment (26% vs 21%, multivariate adjusted relative risk [RR], 1.20; 95% confidence interval [CI], 1.02-1.41). There was a statistically significant interaction with inflammation and the metabolic syndrome (P = .03) on cognitive impairment. After stratifying for inflammation, those with the metabolic syndrome and high inflammation (n = 348) had an increased likelihood of cognitive impairment compared with those without the metabolic syndrome (multivariate adjusted RR, 1.66; 95% CI, 1.19-2.32). Those with the metabolic syndrome and low inflammation (n = 668) did not exhibit an increased likelihood of impairment (multivariate adjusted RR, 1.08; 95% CI, 0.89-1.30). Stratified multivariate random-effects models demonstrated that participants with the metabolic syndrome and high inflammation had greater 4-year decline on 3MS (P = .0... [ABSTRACT FROM AUTHOR]

Presents a study of how sleep-disordered breathing and sleep apnea affect hypertension. Design and setting; Participants; Main outcome measures; Results; Conclusions.

Presents a letter to the editor in reply to Drs. O'Rourke and Safar and focuses on the role of systolic blood pressure and pulse pressure in predicting mortality in chronic kidney disease.