The Effect of Aerobic Exercise on Learning After Stroke

This study has been completed.
Sponsor:
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
  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 April 16, 2014