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

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00105807
• Other study ID #: NRI 99-344
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2005
• Last updated: April 6, 2015
• Start date: July 2002
• Est. completion date: April 2006

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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:

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis

Intervention

Behavioral:
• participation in low intensity exercise

• participation in art and music activities

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,