- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00038155
Rehabilitation for Older Adults From Acute Medical Conditions (STAGE)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35233
- VA Medical Center, Birmingham
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Older patients with ambulation difficulty
Exclusion Criteria:
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 1
|
Recruitment of eligible subjects, ambulatory and resistance training in hospital and post-discharge
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
feasibility of recruitment and intervention
Tidsramme: discharge and 6 months post discharge
|
discharge and 6 months post discharge
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Richard Allman, MD, VA Medical Center, Birmingham
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- E2805G
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