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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014