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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-12-31

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.

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Weight loss

Group Type EXPERIMENTAL

Diet

Intervention Type BEHAVIORAL

10 percent weight loss through diet and behavioral modification

3

Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Multicomponent (resistance, aerobic, balance) exercise three times a week

4

Weight loss and exercise

Group Type EXPERIMENTAL

Weight Loss and Exercise

Intervention Type OTHER

10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Interventions

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Diet

10 percent weight loss through diet and behavioral modification

Intervention Type BEHAVIORAL

Exercise

Multicomponent (resistance, aerobic, balance) exercise three times a week

Intervention Type OTHER

Weight Loss and Exercise

10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Intervention Type OTHER

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.

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No