StrokeTAPASNCT01042990
Testing Adaptive Physical Activity in Stroke
A study testing Adaptive Physical Activity in people with Stroke, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
"Testing Adaptive Physical Activity in Stroke" tests the idea that adaptive physical activity (APA) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Adaptive Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Sep 2011
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic stroke greater than or equal to 6 months prior in men or women ages 40- or older. Hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-or older.
- Residual hemiparetic gait deficits.
- Already completed all conventional inpatient and outpatient physical therapy.
- Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Baltimore VAMC
Baltimore, Maryland, 21201
Kathleen M Michael, PhD, 410-605-7000 ext. 4844, kmichael@grecc.umaryland.edu
Kathleen M Michael, PhD
About this study
"Testing Adaptive Physical Activity in Stroke" tests the idea that adaptive physical activity (APA) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. Adaptive physical activity is an exercise model that combines aerobic exercise with balance and gait training in a socially reinforcing group setting. Individualized homework assignments encourage integration of exercise into daily life routines. Our specific aims are:
- to determine whether APA improves cardiovascular fitness and metabolic health
- to measure the effects of APA on gait and balance, ambulatory activity, and ADL function
- to determine whether APA affects self-reported outcomes related to self-efficacy, fatigue, and stroke-specific quality of life
- Conditions
- Stroke
- Being tested
- Adaptive Physical Activity
- Keywords
- Stroke, Exercise, Balance, Dynamic Gait, Cardiovascular Fitness
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Physical ActivityOther
Structured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Only | Active comparator | Participants receive education and instruction on a home exercise program which they do on their own, with intermittent encouragement from study personnel. Receives: Other: Adaptive Physical Activity |
| APA | Experimental | Participants exercise in a gym setting 3x/week for six months, performing gait and balance exercises along with a progressive walking program. Receives: Other: Adaptive Physical Activity |
| APA+TM | Experimental | Participants exercise in a gym setting 3x/week for six months, performing a combined program of adaptive physical activity (gait and balance training) and progressive treadmill walking. Receives: Other: Adaptive Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 Peak
Measured: baseline, 3 months, 6 months, and 3 months post-intervention
Berg Balance Scale
Measured: baseline, 3 months, 6 months, and 3 months post-intervention
Dynamic Gait Index
Measured: Baseline, 3 months, 6 months, and 3 months post intervention
Step Activity Monitoring
Measured: Baseline, 3 months, 6 months, and 3 months post-intervention
6 Minute Walks
Measured: Baseline, 3 months, 6 months, and 3 months post-intervention
Secondary outcomes (1)
Psychosocial questionnaires
Measured: baseline, 3 months, 6 months, and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland
- Investigators
- Richard F Macko, MD, Principal investigator, University of MarylandKathleen M Michael, PhD, Principal investigator, University of MarylandAndrew P Goldberg, MD, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01042990
- Sponsor's protocol ID
- HP-00040264
- Acronym
- TAPAS
- Status last verified
- Dec 2009
- First submitted
- 5 Jan 2010
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Michael K, Goldberg AP, Treuth MS, Beans J, Normandt P, Macko RF. Progressive adaptive physical activity in stroke improves balance, gait, and fitness: preliminary results. Top Stroke Rehabil. 2009 Mar-Apr;16(2):133-9. doi: 10.1310/tsr1602-133.
PubMed 19581199
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Adaptive Physical Activity in Stroke
- ClinicalTrials.gov ID
- NCT01042990
- Acronym / sponsor ID
- TAPAS / HP-00040264
- Conditions
- Stroke
- Keywords
- Stroke, Exercise, Balance, Dynamic Gait, Cardiovascular Fitness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Collaborators
- University of Maryland
- Study start
- Sep 2008
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 6 Jan 2010 (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.
"Testing Adaptive Physical Activity in Stroke" tests the idea that adaptive physical activity (APA) will improve fitness, balance and walking function, daily step activity, and outcomes related to quality of life in individuals with chronic stroke. Adaptive physical activity is an exercise model that combines aerobic exercise with balance and gait training in a socially reinforcing group setting. Individualized homework assignments encourage integration of exercise into daily life routines. Our specific aims are:
- to determine whether APA improves cardiovascular fitness and metabolic health
- to measure the effects of APA on gait and balance, ambulatory activity, and ADL function
- to determine whether APA affects self-reported outcomes related to self-efficacy, fatigue, and stroke-specific quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Only | Active comparator | Other: Adaptive Physical ActivityParticipants receive education and instruction on a home exercise program which they do on their own, with intermittent encouragement from study personnel. |
| APA | Experimental | Other: Adaptive Physical ActivityParticipants exercise in a gym setting 3x/week for six months, performing gait and balance exercises along with a progressive walking program. |
| APA+TM | Experimental | Other: Adaptive Physical ActivityParticipants exercise in a gym setting 3x/week for six months, performing a combined program of adaptive physical activity (gait and balance training) and progressive treadmill walking. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ischemic stroke greater than or equal to 6 months prior in men or women ages 40- or older. Hemorrhagic stroke greater than or equal to one year prior in men or women ages 40-or older.
- Residual hemiparetic gait deficits.
- Already completed all conventional inpatient and outpatient physical therapy.
- Adequate language and neurocognitive function to participate in exercise testing and training (specific screening instruments used.)
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 |
|---|---|---|
| Adaptive Physical ActivityStructured gait, balance, and progressive walking program performed in a group gym setting 3x/week for 6 months | Other | APA, APA+TM, Home Exercise Only |
Primary outcome
VO2 Peak
Time frame: baseline, 3 months, 6 months, and 3 months post-intervention
Berg Balance Scale
Time frame: baseline, 3 months, 6 months, and 3 months post-intervention
Dynamic Gait Index
Time frame: Baseline, 3 months, 6 months, and 3 months post intervention
Step Activity Monitoring
Time frame: Baseline, 3 months, 6 months, and 3 months post-intervention
6 Minute Walks
Time frame: Baseline, 3 months, 6 months, and 3 months post-intervention
1 secondary outcome
Psychosocial questionnaires
Time frame: baseline, 3 months, 6 months, and 3 months post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2010.
- Results publication: PubMed 19581199Michael K, Goldberg AP, Treuth MS, Beans J, Normandt P, Macko RF. Progressive adaptive physical activity in stroke improves balance, gait, and fitness: preliminary results. Top Stroke Rehabil. 2009 Mar-Apr;16(2):133-9. doi: 10.1310/tsr1602-133.
Related trials for Stroke
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Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
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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 F Macko, MD principal investigator
University of Maryland
Kathleen M Michael, PhD principal investigator
University of Maryland
Andrew P Goldberg, MD principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Physical Activity in people with Stroke, run by Baltimore VA Medical Center 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 4 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: status not confirmed, as of the sponsor's last update on 6 Jan 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen M Michael, PhD (410-605-7000 ext. 4844, kmichael@grecc.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 Peak (time frame: baseline, 3 months, 6 months, and 3 months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01042990, which also lists 1 linked publication.
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 6 Jan 2010.