The Effect of Aerobic Exercise on Learning After Stroke

• Sponsor: University of Kansas (Other)
• Overall Status: Completed
• CT.gov ID: NCT00228306
• Collaborator: American Heart Association (Other)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Sep 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Behavioral: Rehabilitation exercise; Rehab therapy is delivered for 8 weeks.
No Intervention: 2 Control Group

Outcome Measures

Primary Outcome Measures

1. Motor learning behavioral measures; executive function behavioral measures. [Baseline, 8 weeks, 12 weeks]

Secondary Outcome Measures

1. Peak V02 and other aerobic capacity measures. Physical disability measures. [Baseline, 8 weeks, 12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas
• ClinicalTrials.gov Identifier: NCT00228306
• Other Study ID Numbers: 9903; Am Heart Assn 0530208N
• First Posted: Sep 28, 2005
• Last Update Posted: May 1, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of May 1, 2012