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.

Condition	Intervention	Phase
Obesity Obesity in the Elderly	Behavior: diet, exercise	Phase III

Further Study Details: 

Primary Outcomes: physical function, body composition, bone mineral density and turnover, muscle protein synthesis, metabolism
Secondary Outcomes: lipids, glucose tolerance, insulin action, cognition, quality of life
Expected Total Enrollment:  100

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, 100 elderly (65-85 years old) obese men and women (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.

Ages Eligible for Study:  65 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

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, sever orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 yr, current use of bone acting drugs

Please refer to this study by ClinicalTrials.gov identifier  NCT00146107

Dennis T Villareal, MD      314-286-2715    dvillare@im.wustl.edu

Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63131,  United States; Recruiting

Study chairs or principal investigators

Dennis T Villareal, MD,  Principal Investigator,  Washington University School of Medicine   

Study ID Numbers:  R01AG025501-01; R01AG025501
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00146107
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-06