Weight Loss and Exercise in Obese Physically Limited Older Women and Men
This study is currently recruiting patients.
Verified by Washington University School of Medicine August 2005
| Sponsored by: |
Washington University School of Medicine |
| Information provided by: |
Washington University School of Medicine |
| ClinicalTrials.gov Identifier: |
NCT00146107 | |
Purpose
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.
| Condition |
Intervention |
Phase |
Obesity
Obesity in the Elderly
|
Behavior: diet, exercise
|
Phase III
|
MedlinePlus related topics: Obesity
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Weight Loss and Exercise in Frail Obese Elderly Subjects
Further study details as provided by Washington University School of Medicine:
Primary Outcomes: physical function, body composition, bone mineral density and turnover, muscle protein synthesis, metabolism
Secondary Outcomes: lipids, glucose tolerance, insulin action, cognition, quality of life
Expected Total Enrollment: 100
Study start: January 2005; Expected completion: December 2009
Last follow-up: July 2009; Data entry closure: December 2009
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, 100 elderly (65-85 years old) obese men and women (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.
Eligibility
Ages Eligible for Study: 65 Years - 85 Years, Genders Eligible for Study: Both
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, sever orthopedic or neuromuscular impairments, dementia, history of malignancy during the past 5 yr, current use of bone acting drugs
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00146107
Missouri
Washington University School of Medicine, St. Louis, Missouri, 63131, United States; Recruiting
Study chairs or principal investigators
Dennis T Villareal, MD, Principal Investigator, Washington University School of Medicine
More Information
click here for more information about the study
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.
Study ID Numbers: R01AG025501-01; R01AG025501
Last Updated: September 2, 2005
Record first received: September 1, 2005
ClinicalTrials.gov Identifier: NCT00146107Health Authority: United States: Institutional Review Board
