The Effect of Exercise on Muscle, Function and Cost in VA Nursing Home Residents
NCT ID: NCT00105807
Last Updated: 2015-04-07
Study Results
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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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2002-07-31
2006-04-30
Brief Summary
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Detailed Description
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Veterans are admitted to Veterans Health Administration (VA) Nursing Homes (NH) because impairment in their ability to perform activities of daily living (ADL) overwhelms their support system (family/friends) in the community. The etiologies of this impairment are, in part, due to chronic disease, deconditioning, and immobility. Yet, after admission, NH residents frequently have decreased levels of daily activity compared with their preadmission activity. Our preliminary observations suggest that dependent, frail residents improve in function in response to exercise in a NH setting.
Objectives:
By comparing an exercise group with a non-exercise group that receives a comparable level of staff attention and positive reinforcement, we will determine whether changes in function normally associated with low intensity exercise are due to exercise or to other factors.
Methods:
We conducted a blinded, prospective, randomized, controlled, clinical investigation at a VA nursing home, comparing the effect of four months of low intensity exercise with the effect of music and art activity on: 1) muscle mass, assessed by DEXA scan; 2) physical function, assessed by timed performance tests, strength and independence in ADL; and 3) the cost of NH care, assessed by measuring the cost of providing care within the NH minus the cost of providing the intervention. Study setting is a VA nursing home, resident participants are new admissions to the NH and are 65 years or older. All participants must be able to follow a one step command and be able to participate in group activity. Participants with a Mini Mental Status Exam (MMSE) of less than 24/30 must have consent of authorized representative. Screening of candidates is completed on all NH admissions. Upon completion of the consent process, participants are randomly assigned to either the exercise group or the music/art group. Baseline tests including the DEXA scan, timed performance tests and observation of ADL is completed prior to participation in activity. At the conclusion of four months of activity, all baseline tests are repeated.
Status:
Recruitment and intervention stage of this project has been completed. In order to achieve our desired number of participants, a request was made and approval received for an extension of recruitment stage from March 2005 until December 2005. Interventions would continue through March 2006 and analysis of data completed in December 2006.
Conditions
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Study Design
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TREATMENT
Study Groups
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Arm 1
participation in low intensity exercise
participation in art and music activities
Interventions
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participation in low intensity exercise
participation in art and music activities
Eligibility Criteria
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Inclusion Criteria
65 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Mary M. Grant, BSN MA
Role: PRINCIPAL_INVESTIGATOR
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Locations
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Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States
Countries
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Other Identifiers
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NRI 99-344
Identifier Type: -
Identifier Source: org_study_id
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