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Sponsored by: |
Washington University School of Medicine |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00146107 |
The purpose of this study is to determine the effect of weight loss and exercise on physical function, body fat and muscle mass, bone strength, and quality of life.
Condition | Intervention | Phase |
---|---|---|
Obesity |
Behavioral: Diet Other: Exercise Other: Weight Loss and Exercise |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Weight Loss and Exercise in Frail Obese Elderly Subjects |
Estimated Enrollment: | 110 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: No Intervention | |
2: Experimental
Weight loss
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Behavioral: Diet
10 percent weight loss through diet and behavioral modification
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3: Experimental
Exercise
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Other: Exercise
Multicomponent (resistance, aerobic, balance) exercise three times a week
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4: Experimental
Weight loss and exercise
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Other: Weight Loss and Exercise
10% weight loss through diet and exercise plus multicomponent exercise training three times a week
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Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty by exacerbating the decline in strength, endurance, balance and mobility associated with aging and physical inactivity. The primary objectives of the proposed research are to evaluate the independent and combined effects of weight loss and exercise on physical function, body composition, bone and muscle metabolism, and quality of life in frail, obese elderly men and women. The central hypothesis is that in frail obese elderly subjects, weight loss will improve physical function and quality of life, while the addition of exercise will not only augment improvement in these outcomes, but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index [BMI] > 30 kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10% weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.
Ages Eligible for Study: | 65 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dennis T Villareal, MD | 314-286-2715 | dvillare@im.wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St Louis, Missouri, United States, 63131 | |
Contact: Nehu Parimi, MD 314-747-4113 Nparimi@dom.wustl.edu | |
Principal Investigator: Dennis T Villareal, MD |
Principal Investigator: | Dennis T Villareal, MD | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine ( Washington Universtiy School of Medicine ) |
Study ID Numbers: | R01AG025501-01, R01AG025501 |
Study First Received: | September 1, 2005 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00146107 |
Health Authority: | United States: Institutional Review Board |
obesity aging exercise diet |
weight loss physical function Obesity in the Elderly |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overweight Overnutrition |