The Effect of Aerobic Exercise on Learning After Stroke
This study has been completed.
Sponsor:
University of Kansas
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT00228306
First received: September 26, 2005
Last updated: April 27, 2012
Last verified: April 2012
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Purpose
Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in individuals with chronic stroke.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Behavioral: Rehabilitation exercise |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Effect of Cardiovascular Fitness on Motor Learning and Executive Function in Individuals After Stroke |
Resource links provided by NLM:
Further study details as provided by University of Kansas:
Primary Outcome Measures:
- Motor learning behavioral measures; executive function behavioral measures. [ Time Frame: Baseline, 8 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Peak V02 and other aerobic capacity measures. Physical disability measures. [ Time Frame: Baseline, 8 weeks, 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 38 |
| Study Start Date: | September 2005 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Behavioral: Rehabilitation exercise
Rehab therapy is delivered for 8 weeks.
|
|
No Intervention: 2
Control Group
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228306
Locations
| United States, Kansas | |
| University of Kansas Medical Center | |
| Kansas City, Kansas, United States, 66160 | |
Sponsors and Collaborators
University of Kansas
American Heart Association
Investigators
| Principal Investigator: | Barbara Quaney, PT, PhD | University of Kansas |
More Information
No publications provided
| Responsible Party: | University of Kansas |
| ClinicalTrials.gov Identifier: | NCT00228306 History of Changes |
| Other Study ID Numbers: | 9903, Am Heart Assn 0530208N |
| Study First Received: | September 26, 2005 |
| Last Updated: | April 27, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 22, 2013