AgingPhase 2STAGENCT00038155
Rehabilitation for Older Adults From Acute Medical Conditions
A Phase 2 study testing Ambulation training in people with Aging and Frail Elderly, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Frail Elderly
- What is being tested?
- Ambulation training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Sep 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older patients with ambulation difficulty
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, Birmingham
Birmingham, Alabama, 35233
About this study
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 (30m/min). 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.
Read the 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.
- Conditions
- Aging, Frail Elderly
- Being tested
- Ambulation training
- Keywords
- Ambulation, Difficulties in ambulation, Geriatric, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulation trainingProcedure or surgery
Recruitment of eligible subjects, ambulatory and resistance training in hospital and post-discharge
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Procedure: Ambulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of recruitment and intervention
Measured: discharge and 6 months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2002 (estimated)
- Study startMay 2002
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Richard Allman, MD, Principal investigator, VA Medical Center, Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038155
- Sponsor's protocol ID
- E2805G
- Acronym
- STAGE
- Status last verified
- Sep 2010
- First submitted
- 29 May 2002
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation for Older Adults From Acute Medical Conditions
- ClinicalTrials.gov ID
- NCT00038155
- Acronym / sponsor ID
- STAGE / E2805G
- Conditions
- Aging, Frail Elderly
- Keywords
- Ambulation, Difficulties in ambulation, Geriatric, Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2002
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 30 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (30m/min). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Ambulation training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Older patients with ambulation difficulty
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulation trainingRecruitment of eligible subjects, ambulatory and resistance training in hospital and post-discharge | Procedure or surgery | 1 |
Primary outcome
feasibility of recruitment and intervention
Time frame: discharge and 6 months post discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Allman, MD principal investigator
VA Medical Center, Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ambulation training in people with Aging and Frail Elderly, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of recruitment and intervention (time frame: discharge and 6 months post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2010.