- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00228306
The Effect of Aerobic Exercise on Learning After Stroke
April 27, 2012 updated by: University of Kansas
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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Rehab therapy is delivered for 8 weeks.
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No Intervention: 2
Control Group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motor learning behavioral measures; executive function behavioral measures.
Time Frame: Baseline, 8 weeks, 12 weeks
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Baseline, 8 weeks, 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Peak V02 and other aerobic capacity measures. Physical disability measures.
Time Frame: Baseline, 8 weeks, 12 weeks
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Baseline, 8 weeks, 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Barbara Quaney, PT, PhD, University of Kansas Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
September 26, 2005
First Submitted That Met QC Criteria
September 26, 2005
First Posted (Estimate)
September 28, 2005
Study Record Updates
Last Update Posted (Estimate)
May 1, 2012
Last Update Submitted That Met QC Criteria
April 27, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9903 (Other Identifier: CTEP)
- Am Heart Assn 0530208N
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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