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Completed

NCT Number: NCT00146107

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

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.

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Key information

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Washington University School of Medicine

St Louis, Missouri, 63131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet

Behavioral

10 percent weight loss through diet and behavioral modification

Exercise

Other

Multicomponent (resistance, aerobic, balance) exercise three times a week

Weight Loss and Exercise

Other

10% weight loss through diet and exercise plus multicomponent exercise training three times a week

Primary outcomes

  1. physical function

    Time frame: one year

Secondary outcomes

  1. body composition

    Time frame: one year

  2. muscle protein synthesis

    Time frame: one year

  3. quality of life

    Time frame: one year

  4. cognition and mood

    Time frame: one year

  5. metabolism

    Time frame: one year

  6. bone mineral density

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Weight Loss and Exercise in Frail Obese Elderly Subjects

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Sep 5, 2005
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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