Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105807
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-16
Brief Title:
The Effect of Exercise on Muscle Function and Cost in VA Nursing Home Residents
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
The Effect of Exercise on Muscle Function and Cost in VA Nursing Home Residents
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 familyfriends 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
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 familyfriends 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 2430 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 musicart 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
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 familyfriends 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 2430 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 musicart 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None