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CompletedNCT00105807Updated Apr 7, 2015

The Effect of Exercise on Muscle, Function and Cost in VA Nursing Home Residents

A Phase 2 interventional study of participation in low intensity exercise and participation in art and music activities in Muscle Weakness, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
120
Ages
65 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Background:

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.

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Conditions studied

  • Muscle Weakness

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03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's planned enrollment of 120 is above the median of 46 across 444 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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. Nursing Home resident

Exclusion criteria

Exclusion Criteria:

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Study design

Phase
Phase 2
Primary purpose
Treatment
Enrollment
120 participants (estimated)

Study arms

  • Other
    Arm 1

    Behavioral: participation in low intensity exercise · Behavioral: participation in art and music activities

Interventions

  • Behavioralparticipation in low intensity exercise
  • Behavioralparticipation in art and music activities
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Study locations

1 site
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
    Baltimore, Maryland 21201, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00105807
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 17, 2005
Start date
Jul 2002
Completion
Apr 2006
Last update
Apr 7, 2015

Study contacts

Mary M. Grant, BSN MA
principal investigator · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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