Weight Loss and Exercise in Physically Limited Obese Elderly Subjects

ID: NCT00146133
Status: Completed
Phase: Phase 3
Start Date: January 01, 2003
First Submitted: September 01, 2005
Last Updated: May 02, 2006
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Obesity, Frailty, Elderly
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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.

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.
Condition or disease Intervention/treatment Phase

Elderly

Frailty

Obesity

Behavioral: diet, exercise
Other Names
Phase 3

Tracking Information

First Submitted DateSeptember 01, 2005
Last Update Posted DateMay 02, 2006
Start DateJanuary 01, 2003
Completion DateDecember 01, 2004
Primary Completion DateN/A
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • physical function and body composition

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • quality of life, metabolic markers

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleWeight Loss and Exercise in Physically Limited Obese Elderly Subjects
Official TitleEffect of Weight Loss and Physical Training on Musculoskeletal Status, Physical Function, and Quality-of-Life in Physically Limited, Obese, Elderly Subjects
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.

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 TypeInterventional
Study PhasePhase 3
Estimated Enrollment
28
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Single
Primary Purpose
Treatment
Conditions
Elderly
Frailty
Obesity
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: diet, exercise

Other Names
Study Groups/Cohorts
Not Available
Study Arms
Not Available
Arm Intervention/Treatment

Recruitment Information

Recruitment Status:Completed
Enrollment28
Completion DateDecember 01, 2004
Eligibility 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, severe orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 yr, current use of bone acting drugs.
GenderAll
Age65 Years to 85 Years
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT00146133
Other Study ID Numbers
KO7AG2116401
KO7AG2116401
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyN/A
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Dennis T Villareal, MD
Washington University School of Medicine