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

The Washington University

Status and phase: Completed; Phase 3

Conditions: Obesity

Treatments: Other: Weight Loss and Exercise; Behavioral: Diet; Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT00146107

R01AG025501 (U.S. NIH Grant/Contract)

R01AG025501-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 107 patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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107 participants in 4 patient groups

1

No Intervention group

2

Experimental group

Description:

Weight loss

Treatment:

Behavioral: Diet

3

Experimental group

Description:

Exercise

Treatment:

Other: Exercise

4

Experimental group

Description:

Weight loss and exercise

Treatment:

Other: Weight Loss and Exercise