Weight Loss and Exercise in Physically Limited Obese Elderly Subjects

Obesity Clinical Trial

Official title:

Effect of Weight Loss and Physical Training on Musculoskeletal Status, Physical Function, and Quality-of-Life in Physically Limited, Obese, Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146133
• Other study ID #: KO7AG2116401
• Secondary ID: KO7AG2116401
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: May 2, 2006
• Start date: January 2003
• Est. completion date: December 2004

Study information

• Verified date: September 2005
• 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 overall purpose of this research is to determine the effect of weight loss and physical training on quality of life, physical function, metabolism, bone strength, body fat and muscle mass.

Description:

Obesity causes serious medical complications and impairs quality of life. Moreover, in elderly persons, obesity can lead to frailty because of decreased strength, joint function, balance and mobility associated with aging. The primary objective of this study is to evaluate the effect of weight loss and physical training on physical function, body composition, metabolism and quality of life in frail, obese elderly men and women. Subjects are randomized to either control or 10% weight loss plus physical training.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2004
• 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 yr, current use of bone acting drugs.

Study Design

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

Related Conditions & MeSH terms

• Elderly
• Frailty
• Obesity
• Weight Loss

Intervention

Behavioral:
• diet, exercise

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 (2)

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

Villareal DT, Banks M, Sinacore DR, Siener C, Klein S. Effect of weight loss and exercise on frailty in obese older adults. Arch Intern Med. 2006 Apr 24;166(8):860-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical function and body composition
Secondary	quality of life, metabolic markers