Back to resultsWeight Loss and Exercise in Physically Limited Obese Elderly Subjects
Primary Purpose
Obesity, Frailty, Elderly
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
diet, exercise
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, Aging, Frailty, exercise, weight loss
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.
Sites / Locations
- Washington University School of Medicine
Outcomes
Primary Outcome Measures
physical function and body composition
Secondary Outcome Measures
quality of life, metabolic markers
Full Information
NCT ID
NCT00146133
First Posted
September 1, 2005
Last Updated
May 2, 2006
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00146133
Brief Title
Weight Loss and Exercise in Physically Limited Obese Elderly Subjects
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 Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Washington University School of Medicine
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Frailty, Elderly
Keywords
Obesity, Aging, Frailty, exercise, weight loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
28 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
diet, exercise
Primary Outcome Measure Information:
Title
physical function and body composition
Secondary Outcome Measure Information:
Title
quality of life, metabolic markers
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis T Villareal, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15229329
Citation
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. doi: 10.1038/oby.2004.111.
Results Reference
background
PubMed Identifier
16636211
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. doi: 10.1001/archinte.166.8.860.
Results Reference
result
Learn more about this trial
Weight Loss and Exercise in Physically Limited Obese Elderly Subjects
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