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Clinical Trials/NCT00146107
NCT00146107
Completed
Phase 3

Weight Loss and Exercise in Frail Obese Elderly Subjects

Washington University School of Medicine1 site in 1 country107 target enrollmentJanuary 2005
ConditionsObesity

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Obesity
Sponsor
Washington University School of Medicine
Enrollment
107
Locations
1
Primary Endpoint
physical function
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2005
End Date
December 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dennis T. Villareal

Associate Professor

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • Obese (BMI 30 or greater)
  • Elderly (age 65 years or older)

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.

Outcomes

Primary Outcomes

physical function

Time Frame: one year

Secondary Outcomes

  • 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)

Study Sites (1)

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