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

Obesity Clinical Trial

Official title:

Weight Loss and Exercise in Frail Obese Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146107
• Other study ID #: R01AG025501-01
• Secondary ID: R01AG025501
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: April 22, 2013
• Start date: January 2005
• Est. completion date: December 2010

Study information

• Verified date: April 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Diet
10 percent weight loss through diet and behavioral modification

Other:
• Exercise
Multicomponent (resistance, aerobic, balance) exercise three times a week
• Weight Loss and Exercise
10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (1)

Villareal DT, Banks M, Siener C, Sinacore DR, Klein S. Physical frailty and body composition in obese elderly men and women. Obes Res. 2004 Jun;12(6):913-20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical function		one year	No
Secondary	body composition		one year	No
Secondary	muscle protein synthesis		one year	No
Secondary	quality of life		one year	No
Secondary	cognition and mood		one year	No
Secondary	metabolism		one year	No
Secondary	bone mineral density		1 year	Yes