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The Effect of Aerobic Exercise on Learning After Stroke

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ClinicalTrials.gov Identifier: NCT00228306
Recruitment Status : Completed
First Posted : September 28, 2005
Last Update Posted : May 1, 2012
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
University of Kansas Medical Center ( University of Kansas )

Brief Summary:
Determine if attaining aerobic fitness is beneficial in producing cortical neuroplasticity in individuals with chronic stroke.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Rehabilitation exercise Phase 1

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  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Cardiovascular Fitness on Motor Learning and Executive Function in Individuals After Stroke
Study Start Date : September 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Experimental: 1 Behavioral: Rehabilitation exercise
Rehab therapy is delivered for 8 weeks.

No Intervention: 2
Control Group



Primary Outcome Measures :
  1. Motor learning behavioral measures; executive function behavioral measures. [ Time Frame: Baseline, 8 weeks, 12 weeks ]

Secondary Outcome Measures :
  1. Peak V02 and other aerobic capacity measures. Physical disability measures. [ Time Frame: Baseline, 8 weeks, 12 weeks ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT00228306     History of Changes
Other Study ID Numbers: 9903
Am Heart Assn 0530208N
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases