Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038155
Status:
COMPLETED
Last Update Posted:
2010-09-24
First Post:
2002-05-29
Brief Title:
Rehabilitation for Older Adults From Acute Medical Conditions
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Rehabilitation for Older Adults From Acute Medical Conditions
Status:
COMPLETED
Status Verified Date:
2010-09
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:
STAGE
Brief Summary:
Hospitalization for an acute medical condition often results in functional decline in older adults This loss of function often is not reversed after hospital discharge Our general hypothesis is that patients will benefit from rehabilitation that occurs simultaneously with the medical management of acute conditions and when linked with a home exercise program that can be implemented after discharge from the hospital This approach differs from the traditional approach of addressing rehabilitation needs after acute conditions have resolved and providing rehabilitation services for selected patients in institutional settings such as subacute units or nursing homes The feasibility of the program will be assessed by documenting the participation of subjects during the inpatient phase and adherence of subjects with the home-based program Fifty subjects will be recruited from individuals who are 60 years of age or older who have been admitted to the Birmingham Veterans Affairs Medical Center VAMC for treatment of an acute medical condition Subjects will be either unable to ambulate require assistance for ambulation or be unable to ambulate a functional distance 150 feet at a functional velocity 30mmin Subjects will be randomly assigned to a physical rehabilitation group PR or to a control group CON During hospitalization subjects in the PR group daily will have one 45-minute morning rehabilitation session and one 30-minute evening rehabilitation session Both sessions will include ambulation and transfer training The longer morning session will also include resistance exercise Subjects in the CON group will have medial care as it is currently provided During the six months after discharge subjects in the PR group will perform a home-based exercise program consisting of ambulation and resistance exercises The program will be monitored and progressed by an exercise physiologist who will visit subjects weekly for the first month after discharge every other week for the second and third months after discharge and monthly in the fourth fifth and six months after discharge This study is designed to test the feasibility and effectiveness of a practical and potentially cost-effective rehabilitation program
Detailed Description:
Specific Objectives of the Project
Specific Objective 1
To evaluate the feasibility of inpatient rehabilitation during hospitalization followed by a home-based exercise program in older persons who are limited in ambulation when admitted to the hospital Feasibility will be determined by our ability to identify recruit and enroll subjects by the ability of subjects to complete two sessions of rehabilitation each day during the inpatient phase and by subject adherence to the home-based program Adherence to the home-based program will be assessed through regular visits and review of activity logs Criteria for feasibility will be successful recruitment of fifty study subjects meeting inclusion and exclusion criteria participation in at least 80 of scheduled inpatient rehabilitation sessions and in at least 80 of prescribed home exercise sessions
Specific Objective 2
To study the impact of a standardized twice daily inpatient rehabilitation program on ambulation ability to perform transfers and self-care and muscle strength at hospital discharge in older adults hospitalized for an acute medical condition We will study individuals who have either lost the ability to ambulate independently within the two weeks before hospitalization or have limited ability to ambulate less than 150 feet at a functional velocity The primary outcome measure for this objective will be the Timed Up and Go TUG test 41 Ambulation transfers and self-care also will be assessed using the locomotion mobility and self care subscales of the Functional Independence Measure FIM 15 22-24 The Microfit 2 hand-held dynamometer HHD will be used to test muscle strength of six lower extremity muscle groups and three upper extremity muscle groups 44 An important outcome assessment will be the proportion of subjects that regain independence in ambulation by hospital discharge
Specific Objective 3
To study the effect of a combined program of inpatient rehabilitation with a progressive home-based exercise training program during the six months following discharge on ambulation ability to perform transfers and self care walking endurance and mobility within the home and community The Timed Up and Go TUG test will be the primary outcome measure Ambulation ability to perform transfers and self-care and muscle strength also will be assessed using the measures described for the second specific objective The Six Minute Walk Test 6 MWT will be used to evaluate walking endurance while a life-space assessment will be used to evaluate mobility within the home and the community 42
The study will be a randomized controlled clinical trial involving a physical rehabilitation PR group and a control CON group Fifty subjects who meet the study criteria will be randomly assigned to PR or CON PR will receive an intensive rehabilitation program consisting of progressive ambulation transfer training and resistance exercise during hospitalization A similar home exercise program will be prescribed during the six months post-hospitalization The CON group will receive routine medical care as it is currently provided
Specific Objective 1
To evaluate the feasibility of inpatient rehabilitation during hospitalization followed by a home-based exercise program in older persons who are limited in ambulation when admitted to the hospital Feasibility will be determined by our ability to identify recruit and enroll subjects by the ability of subjects to complete two sessions of rehabilitation each day during the inpatient phase and by subject adherence to the home-based program Adherence to the home-based program will be assessed through regular visits and review of activity logs Criteria for feasibility will be successful recruitment of fifty study subjects meeting inclusion and exclusion criteria participation in at least 80 of scheduled inpatient rehabilitation sessions and in at least 80 of prescribed home exercise sessions
Specific Objective 2
To study the impact of a standardized twice daily inpatient rehabilitation program on ambulation ability to perform transfers and self-care and muscle strength at hospital discharge in older adults hospitalized for an acute medical condition We will study individuals who have either lost the ability to ambulate independently within the two weeks before hospitalization or have limited ability to ambulate less than 150 feet at a functional velocity The primary outcome measure for this objective will be the Timed Up and Go TUG test 41 Ambulation transfers and self-care also will be assessed using the locomotion mobility and self care subscales of the Functional Independence Measure FIM 15 22-24 The Microfit 2 hand-held dynamometer HHD will be used to test muscle strength of six lower extremity muscle groups and three upper extremity muscle groups 44 An important outcome assessment will be the proportion of subjects that regain independence in ambulation by hospital discharge
Specific Objective 3
To study the effect of a combined program of inpatient rehabilitation with a progressive home-based exercise training program during the six months following discharge on ambulation ability to perform transfers and self care walking endurance and mobility within the home and community The Timed Up and Go TUG test will be the primary outcome measure Ambulation ability to perform transfers and self-care and muscle strength also will be assessed using the measures described for the second specific objective The Six Minute Walk Test 6 MWT will be used to evaluate walking endurance while a life-space assessment will be used to evaluate mobility within the home and the community 42
The study will be a randomized controlled clinical trial involving a physical rehabilitation PR group and a control CON group Fifty subjects who meet the study criteria will be randomly assigned to PR or CON PR will receive an intensive rehabilitation program consisting of progressive ambulation transfer training and resistance exercise during hospitalization A similar home exercise program will be prescribed during the six months post-hospitalization The CON group will receive routine medical care as it is currently provided
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