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

Weight Loss and Exercise in Frail Obese Elderly Subjects

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00146107
Enrollment
107
Registered
2005-09-05
Start date
2005-01-31
Completion date
2010-12-31
Last updated
2013-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, aging, exercise, diet, weight loss, physical function, Obesity in the Elderly

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.

Interventions

BEHAVIORALDiet

10 percent weight loss through diet and behavioral modification

OTHERExercise

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

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

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
physical functionone year

Secondary

MeasureTime frame
muscle protein synthesisone year
quality of lifeone year
body compositionone year
metabolismone year
bone mineral density1 year
cognition and moodone year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026