Weight Loss and Exercise in Physically Limited Obese Elderly Subjects

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00146133
First received: September 1, 2005
Last updated: May 2, 2006
Last verified: September 2005
  Purpose

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 Intervention Phase
Obesity
Frailty
Elderly
Behavioral: diet, exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • physical function and body composition

Secondary Outcome Measures:
  • quality of life, metabolic markers

Estimated Enrollment: 28
Study Start Date: January 2003
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00146133

Locations
United States, Missouri
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00146133     History of Changes
Other Study ID Numbers: KO7AG2116401, KO7AG2116401
Study First Received: September 1, 2005
Last Updated: May 2, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Obesity, Aging, Frailty, exercise, weight loss

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 28, 2014