The Effect of Aerobic Exercise on Learning After Stroke

This study is ongoing, but not recruiting participants.

First Received: September 26, 2005 Last Updated: September 10, 2008 History of Changes

Sponsors and Collaborators:	University of Kansas American Heart Association
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00228306

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Effect of Cardiovascular Fitness on Motor Learning and Executive Function in Individuals After Stroke

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Rehabilitation

U.S. FDA Resources

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 ]

Estimated Enrollment:	40
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Behavioral: Rehabilitation exercise Rehab therapy is delivered for 8 weeks.
2: No Intervention 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 Medical Center ( Barbara Quaney, PT, PhD )
Study ID Numbers:	9903, Am Heart Assn 0530208N
Study First Received:	September 26, 2005
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00228306 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases

Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on September 03, 2009