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Weight Loss and Exercise in Physically Limited Obese Elderly Subjects

NCT ID: NCT00146133

Last Updated: 2006-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-12-31

Brief Summary

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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

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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.

Conditions

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Obesity Frailty Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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diet, exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Dennis T Villareal, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15229329 (View on PubMed)

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.

Reference Type RESULT
PMID: 16636211 (View on PubMed)

Other Identifiers

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KO7AG2116401

Identifier Type: -

Identifier Source: secondary_id

KO7AG2116401

Identifier Type: -

Identifier Source: org_study_id