Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Weight Loss and Exercise in Frail Obese Elderly Subjects

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Diet
* Other: Exercise
* Other: Weight Loss and Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese (BMI 30 or greater) Elderly (age 65 years or older) Frailty Exclusion Criteria: Major chronic disease or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results. Examples include cardiopulmonary disease, unstable disease, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 years, or current use of bone acting drugs.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br>Weight loss | Behavioral: Diet<br>* 10 percent weight loss through diet and behavioral modification<br>|
| Experimental: 3<br>Exercise | Other: Exercise<br>* Multicomponent (resistance, aerobic, balance) exercise three times a week<br>|
| Experimental: 4<br>Weight loss and exercise | Other: Weight Loss and Exercise<br>* 10% weight loss through diet and exercise plus multicomponent exercise training three times a week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition |  | one year | 
| muscle protein synthesis |  | one year | 
| quality of life |  | one year | 
| cognition and mood |  | one year | 
| metabolism |  | one year | 
| bone mineral density |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, aging, exercise, diet, weight loss, physical function, Obesity in the Elderly