Lifestyle Interventions and Independence for Elders
Principal Investigator: Barbara J Nicklas, PhD
Study Description: The Lifestyle Interventions and Independence for Elders (LIFE) study was a four-site, single-blind randomized, controlled clinical trial in 424 elderly men and women (70-90 yrs) at risk for physical disability. LIFE participants were sedentary and physically impaired, but ambulatory, community-living older persons. The study was designed to compare a 12-month physical activity (PA) intervention (primarily walking) to a non-exercise (successful aging, SA) intervention on incidence of mobility disability or death. LIFE was a pilot study to obtain sample size estimates and incidence rates for these definitive outcomes; yet, it is one of the largest exercise trials in this age group to date, with sufficient power for assessing the effects of the intervention on intermediary outcomes.
Primary Results: The mean baseline SPPB score on a scale of 0–12, with 12 corresponding to highest performance, was 7.5. At 6 and 12 months, the PA versus SA group adjusted SPPB (6 standard error) scores were 8.7 6 0.1 versus 8.0 6 0.1, and 8.5 6 0.1 versus 7.9 6 0.2, respectively (p<0.001). The 400-meter walking speed was also significantly improved in the PA group. The PA group had a lower incidence of major mobility disability defined as incapacity to complete a 400-meter walk (hazard ratio=0.71, 95% confidence interval=0.44–1.20).
Samples Available: DNA, serum and EDTA-treated, citrated, and heparinized plasma
Diet, Exercise, and Metabolism in Older Women (DEMO)
Principal Investigator: Barbara J Nicklas, PhD
Study Description: The DEMO study was a randomized trial in 112 overweight and obese (BMI=25–40 kg/m2; waist >88 cm), postmenopausal women (50-70 yrs) assigned to one of three 20-week interventions of equal energy deficit: caloric restriction (CR Only), CR plus moderate-intensity aerobic exercise (CR+Moderate-intensity), or CR plus vigorous-intensity exercise (CR+Vigorous-intensity). The diet was a controlled program of underfeeding during which meals were provided at individual calorie levels (~400 kcal/day). Exercise (3 days/week) involved treadmill walking at an intensity of 45-50% (Moderate-intensity) or 70-75% (Vigorous-intensity) of heart rate reserve. The primary outcome was abdominal visceral fat volume.
Primary Results: Average weight loss for the 95 women who completed the study was 12.1(4.5) kg and was not different across groups. VO2max increased more in the CR+Vigorous-intensity group than either of the other groups (P<0.05). All groups showed similar decreases in abdominal visceral fat (approximately 25%, P<0.001 for all). Changes in lipids, fasting glucose/insulin, and 2-hr glucose and insulin areas during the OGTT were similar across treatment groups.
Analysis of abdominal and gluteal subcutaneous adipose tissue metabolism, including gene expression, lipolysis, and cytokine release, is on-going. In addition, the study has measures of resting metabolic rate and physical activity energy expenditure, as well as a 1-year follow-up of weight regain following the interventions.
Samples Available: DNA, serum and EDTA-treated plasma
Physical Function, Arthritis, Inflammation and Body Composition Trial (PACT)
Principal Investigator: Gary D. Miller, PhDStudy Description: PACT examined the effects of caloric restriction combined with exercise on physical function in older obese adults. The study compared a 6-month dietary restriction and exercise intervention (WL) to a weight stable (WS) control group in 87 men and women (≥60 yrs; BMI ≥30.0 kg/m2) with knee osteoarthritis. Those in WL underwent an intervention designed to elicit a 10% weight loss through incorporation of meal replacements (2 meals/d of Slimfast®) and nutrition education, along with an exercise program consisting of 3 d/wk of up to 40 mins of aerobic exercise (walking) and 20 mins of RT. Those in WS participated in monthly health education sessions.
Primary Results: Body weight decreased -7.8±5.2 kg (8.7%) in WL and was unchanged (0.3±4.0 kg) in WS in the 73 persons who completed the study. The WL group lost significantly more fat mass (-5.4±4.2 vs. 0.0±2.8 kg) and lean mass (-1.8±2.3 vs. 0.4±2.4 kg) than WS (p<0.01). Despite this loss in lean mass, physical function improved more in the WL than WS group. In addition, changes in walk distance, and muscle strength and quality were inversely associated with changes in body mass, fat mass, and % body fat. Muscle biopsies were performed in a subset of PACT subjects.
Samples Available: Serum and EDTA-treated plasma
Optimizing Body Composition for Function in Older Adults (OPTIMA)
Principal Investigator: Stephen Kritchevsky, PhDStudy Description: The OPTIMA pilot study compared the main effects of 2 separate interventions (in a factorial design) on body composition, physical function, and body fat distribution in 88 older men (n=48) and women (n=40). All participants underwent a 4-mo hypocaloric diet for weight loss (WL) intervention with or without resistance exercise training (RT), and received either pioglitazone/Actos™ (30 mg/day, PIO) or a placebo. Thus, the 4 study groups were: 1) WL alone, 2) WL+RT; 3) WL+PIO; or 4) WL+RT+PIO.
All OPTIMA participants were older (age 65-79 yrs) adults, with low physical function and an indication for weight loss (BMI≥30 kg/m2, or 25-29.9 kg/m2 with a waist circumference >35 inches for women or >40 inches for men). The diet intervention incorporated meal replacements (2/day), nutrition education (weekly meetings with RD), and behavior modification to meet a weight loss goal of ~8%. RT included supervised training 3 d/wk with a goal to complete 3 sets of 10 repetitions at 70% of 1RM.
Primary Results: The average weight loss in the 37 women and 44 men who completed the study was -5.7±3.2 kg (6.6%) and -7.0±4.7 kg (6.8%), respectively (both p<0.05). There was no difference in total weight lost between PIO or RT groups in either men or women. Compared to placebo, PIO treatment did not effect the absolute loss of fat or lean mass in either men or women; however, in men (but not women), PIO use resulted in a greater decrease in percent body fat (PIO= -3.3±2.4%; placebo= -1.8±1.3%; p=0.02). Additionally, in men, PIO treatment resulted in a greater reduction in visceral fat volume than the placebo group (average between group change of -513 ml; 95% CI: -880 to -146 ml; p=0.008); but, in women there was no significant effect of PIO on loss of visceral fat. Loss of lean mass and thigh muscle volume was significant in all groups, but was attenuated in the WL+RT group. Despite this loss of muscle tissue, physical function and muscle quality improved significantly in the WL+RT group.
Samples Available: Serum and EDTA-treated plasma
Pharmacologic Intervention in the Elderly (PIE and PIE II)
Principal Investigator: Dalane W. Kitzman, MD
Study Description: The PIE study investigated the effects of 12-months of ACE inhibitor use on aortic distensibility and wall thickness, left ventricular mass, exercise tolerance, and quality of life in 80 (40 placebo and 40 treatment) elderly (>60 yrs) patients with diastolic heart failure.
The PIE II study investigated the use of Spironolactone (an aldosterone antagonist) on these same outcomes in 80 (40 placebo and 40 treatment) elderly (>60 yrs) patients with diastolic heart failure. All PIE and PIE II participants also had measures of physical function and body composition measured by DXA.
Samples Available: Serum, EDTA-treated plasma and DNA
Reconditioning Exercise and COPD Trial (REACT II)
Principal Investigator: Michael Berry, PhD
Study Description: The REACT II study was a randomized, single-blind clinical trial among 200 patients with chronic obstructive pulmonary disease (COPD) that compared the effects of a 12-month lifestyle activity intervention to a traditional 3-month center-based exercise program on compliance with physical activity, exercise capacity, pulmonary function, health-related quality of life and physical function after 12 months. Blood was drawn at baseline, 3 months, and 12 months follow-up. All REACT II participants also had measures of physical function and body composition measured by DXA.
Samples Available: Serum, EDTA plasma and DNA
Resistance Training to Increase Muscle Power in Older Adults (POWER)
Principal Investigator: Tony Marsh, PhD
Study Description: The POWER study was a randomized, controlled pilot study in 45 adults >65 yrs with mild to moderate self-reported disability. The intervention consisted of comparing a 12-week progressive resistance training (PRT) designed to increase lower extremity muscle power to a 16-week traditional PRT and a control group on the primary outcomes of lower extremity muscle power and strength. The primary goals of the pilot were to examine the safety and feasibility of the Power training in older adults and to obtain an estimate of the intervention effect size for use in planning a definitive randomized trial. The secondary aims were to determine the effects of the interventions on physical function, self-reported disability, body composition, muscle cell contractile function, and health-related quality of life.
Samples Available: EDTA plasma and serum
Reducing Age Related Inflammation with Nutritional Supplementation (RAINS)
Principal Investigator: Stephen Kritchevsky, PhD
Study Description: The RAINS study investigated the effectiveness of 12-week use of a nutritional supplement that was designed to increase muscle synthesis and reduce muscle catabolism, to reduce inflammatory markers, and improve insulin sensitivity. The study enrolled 67 sedentary adults aged 65-85 yrs with evidence of a functional limitation. The supplement was given daily for 12 weeks. Inflammatory biomarkers, fasting glucose, insulin levels, and physical function and strength tests were measured pre- and post-intervention.
Primary Results: There was no evidence that the supplement (containing 21g protein: Leucine (4.3g) and Arginine (1.92g), 12g fat: n-6:n-3 (ratio 1.1:1), 1g EPA, and 0.65g DHA) reduced inflammatory markers or improved insulin sensitivity. There was some improvement in physical function (SPPB score and walking speed, p<0.03, p<0.001, respectively) and strength (leg power, p<0.02). A causal association could not be confirmed as there was no control group.
Samples Available: EDTA-plasma and serum
Cooperative Lifestyle Intervention Program (CLIP)
Principal Investigator: Jack Rejeski, PhDStudy Description: The CLIP study was an 18-month randomized, controlled trial of the effectiveness of physical activity, with and without weight loss, in the treatment of mobility disability in 300 older (60-79 years), overweight/obese men and women with evidence of CVD or the metabolic syndrome. Participants were randomized to one of the 3 intervention groups: 1) a “successful aging” education control condition; 2) a group treatment program for physical activity; and 3) a lifestyle intervention designed to promote weight loss and increase physical activity. The primary aim is to compare the effects of the three treatments on 18-month change in mobility disability, as assessed by the distance walked during a 400m walk test. A secondary aim is to test the effects of the interventions on change in: CVD risk factors (high-sensitivity CRP, lipid profiles, glucose and insulin, blood pressure), physical activity and dietary intake, body composition (DXA), and on health-related quality of life.
Samples Available: EDTA-plasma and serum
Intensive Dietary Restriction and Exercise in Arthritis (IDEA)
Principal Investigator: Steve Messier, PhDStudy Description: The IDEA study is a randomized, controlled trial in 450 older (>60 yrs), overweight/obese (BMI=27-40 kg/m2) men and women with knee OA randomized to either 18 months of a Diet only, Exercise only, or Diet+Exercise intervention. Both the Diet only and Diet+Exercise groups receive the same dietary therapy (based on partial meal replacements) designed to achieve a weight loss of 10% of initial body weight. The exercise intervention is identical for both exercise groups and involves 60-minute sessions conducted 3 d/wk of aerobic (primarily walking) and resistance exercise. The primary aim is to compare the effects of the interventions on the primary outcomes of inflammatory biomarkers (CRP, IL-6, TNFa) and knee joint loads and on the secondary outcomes of body composition (via DXA), self-reported physical function, pain, and mobility, and on disease progression measured by changes in quantitative MRI. The study will also determine whether inflammatory biomarkers and knee joint loads are mediators of the interventions, with significant effects on function, pain, and mobility.
Samples Available: DNA, EDTA-plasma and serum