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

Phase 3

Completed

• Conditions: Obesity
• Interventions: Behavioral: Diet; Other: Exercise; Other: Weight Loss and Exercise

• Registration Number: NCT00146107
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-05
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-22
• Last Update Posted: 2013-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Diet	Weight loss
3	Exercise	Exercise
4	Weight Loss and Exercise	Weight loss and exercise

Primary Outcome Measures

Name	Time	Method
physical function	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St Louis, Missouri, United States