Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis T. Villareal, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00146107
First received: September 1, 2005
Last updated: April 22, 2013
Last verified: April 2013

September 1, 2005
April 22, 2013
January 2005
December 2010   (final data collection date for primary outcome measure)
physical function [ Time Frame: one year ] [ Designated as safety issue: No ]
physical function, body composition, bone mineral density and turnover, muscle protein synthesis, metabolism
Complete list of historical versions of study NCT00146107 on ClinicalTrials.gov Archive Site
  • body composition [ Time Frame: one year ] [ Designated as safety issue: No ]
  • muscle protein synthesis [ Time Frame: one year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
  • cognition and mood [ Time Frame: one year ] [ Designated as safety issue: No ]
  • metabolism [ Time Frame: one year ] [ Designated as safety issue: No ]
  • bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
lipids, glucose tolerance, insulin action, cognition, quality of life
Not Provided
Not Provided
 
Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men
Weight Loss and Exercise in Frail Obese Elderly Subjects

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.

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, 110 elderly (65-85 years old) obese men and women (body mass index [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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Obesity
  • Behavioral: Diet
    10 percent weight loss through diet and behavioral modification
  • Other: Exercise
    Multicomponent (resistance, aerobic, balance) exercise three times a week
  • Other: Weight Loss and Exercise
    10% weight loss through diet and exercise plus multicomponent exercise training three times a week
  • No Intervention: 1
  • Experimental: 2
    Weight loss
    Intervention: Behavioral: Diet
  • Experimental: 3
    Exercise
    Intervention: Other: Exercise
  • Experimental: 4
    Weight loss and exercise
    Intervention: Other: Weight Loss and Exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
December 2010
December 2010   (final data collection date for primary outcome measure)

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 years, or current use of bone acting drugs.
Both
65 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00146107
R01AG025501-01, R01AG025501
Yes
Dennis T. Villareal, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Dennis T Villareal, MD Washington University School of Medicine
Washington University School of Medicine
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP