StrokePhase 1NCT00228306
The Effect of Aerobic Exercise on Learning After Stroke
A Phase 1 study testing Rehabilitation exercise in people with Stroke, run by University of Kansas at 1 site in United States.
Trial summary
Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- Rehabilitation exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Dec 2009
- Phase
- Phase 1
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single ischemic stroke occuring 6-72 months prior
- Fugl-Meyer score (upper + lower extremity) 45 or greater
- Mini mental status score of >23
- approval of the subject's medical doctor
Who cannot join
- already performing >20 min of cardiovascular exercise 3x/wk or more
- alcohol consumption of >2 oz. liquor, 8 oz. wine or 24 oz beer/day
- cardiac history of unstable angina, recent myocardia infarction within the last 3 months, congestive heart failure, significant valve dysfunction
- medical history of recent hospitalization (> 3 months) for medical illness
- symptomatic peripheral arterial occlusive disease
- orthopedic or chronic pain conditions restricting exercise
Show all 13Show fewer
- pulmonary or renal failure
- active cancer
- unstable hypertension (>160/100 mmHg)
- diabetes mellitus (fasting glucose > 180 NG./dk, HgA1C > 10%) that is unable to be controlled < month
- receptive or expressive aphasia as indicated on MMSE
- multiple strokes or other neuromuscular conditions
- major depression that is untreated using the Beck depression inventory
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Effect of Cardiovascular Fitness on Motor Learning and Executive Function in Individuals After Stroke
Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in individuals with chronic stroke.
Read the detailed description
Crossover clinical trial. Experimental group undergoes 3x/wk/6 months of aerobic conditioning. Control group performs usual daily activities. All participants will be assessed with cognitive and motor behavioral testing at baseline, 3, 6, 9 and 12 months.
- Conditions
- Stroke
- Being tested
- Rehabilitation exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation exerciseBehavioural
Rehab therapy is delivered for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Rehabilitation exercise |
| 2 | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor learning behavioral measures; executive function behavioral measures.
Measured: Baseline, 8 weeks, 12 weeks
Secondary outcomes (1)
Peak V02 and other aerobic capacity measures. Physical disability measures.
Measured: Baseline, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionDec 2008
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Barbara Quaney, PT, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00228306
- Sponsor's protocol ID
- 9903
- Other IDs
- Am Heart Assn 0530208N
- Status last verified
- Apr 2012
- First submitted
- 26 Sep 2005
- Last updated
- 1 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cardiovascular Fitness on Motor Learning and Executive Function in Individuals After Stroke
- ClinicalTrials.gov ID
- NCT00228306
- Acronym / sponsor ID
- 9903
- Conditions
- Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Sep 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Sep 2005 (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.
Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in individuals with chronic stroke.
Detailed description
Crossover clinical trial. Experimental group undergoes 3x/wk/6 months of aerobic conditioning. Control group performs usual daily activities. All participants will be assessed with cognitive and motor behavioral testing at baseline, 3, 6, 9 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Rehabilitation exercise |
| 2 | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Single ischemic stroke occuring 6-72 months prior
- Fugl-Meyer score (upper + lower extremity) 45 or greater
- Mini mental status score of >23
- approval of the subject's medical doctor
Key exclusion criteria (13 listed)
- already performing >20 min of cardiovascular exercise 3x/wk or more
- alcohol consumption of >2 oz. liquor, 8 oz. wine or 24 oz beer/day
- cardiac history of unstable angina, recent myocardia infarction within the last 3 months, congestive heart failure, significant valve dysfunction
- medical history of recent hospitalization (> 3 months) for medical illness
- symptomatic peripheral arterial occlusive disease
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 |
|---|---|---|
| Rehabilitation exerciseRehab therapy is delivered for 8 weeks. | Behavioural | 1 |
Primary outcome
Motor learning behavioral measures; executive function behavioral measures.
Time frame: Baseline, 8 weeks, 12 weeks
1 secondary outcome
Peak V02 and other aerobic capacity measures. Physical disability measures.
Time frame: Baseline, 8 weeks, 12 weeks
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 1 May 2012.
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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.
Barbara Quaney, PT, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rehabilitation exercise in people with Stroke, run by University of Kansas 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 13 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 1 May 2012. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Motor learning behavioral measures; executive function behavioral measures. (time frame: Baseline, 8 weeks, 12 weeks). 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 1 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.