Weight Loss and Exercise in Physically Limited Obese Elderly Subjects

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT00146133
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Duration (Months): 23
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity; Frailty; Elderly	Behavioral: diet, exercise	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Effect of Weight Loss and Physical Training on Musculoskeletal Status, Physical Function, and Quality-of-Life in Physically Limited, Obese, Elderly Subjects
• Study Start Date: Jan 1, 2003
• Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. physical function and body composition []

Secondary Outcome Measures

1. quality of life, metabolic markers []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts 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 yr, current use of bone acting drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	St Louis	Missouri	United States	63108

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00146133
• Other Study ID Numbers: KO7AG2116401; KO7AG2116401
• First Posted: Sep 5, 2005
• Last Update Posted: May 3, 2006
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: Obesity, Aging, Frailty, exercise, weight loss
• Additional relevant MeSH terms: Weight Loss; Frailty

Study Results

No Results Posted as of May 3, 2006