The Effect of Exercise on Muscle, Function and Cost in VA Nursing Home Residents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00105807|
Recruitment Status : Completed
First Posted : March 17, 2005
Last Update Posted : April 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Muscle Weakness||Behavioral: participation in low intensity exercise Behavioral: participation in art and music activities||Phase 2|
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.
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Official Title:||The Effect of Exercise on Muscle, Function and Cost in VA Nursing Home Residents|
|Study Start Date :||July 2002|
|Actual Study Completion Date :||April 2006|
|Arm 1||Behavioral: participation in low intensity exercise Behavioral: participation in art and music activities|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00105807
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Mary M. Grant, BSN MA||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|