The Effect of Aerobic Exercise on Learning After Stroke

Stroke Clinical Trial

Official title:

Effect of Cardiovascular Fitness on Motor Learning and Executive Function in Individuals After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228306
• Other study ID #: 9903
• Secondary ID: Am Heart Assn 05
• Status: Completed
• Phase: Phase 1
• First received: September 26, 2005
• Last updated: April 27, 2012
• Start date: September 2005
• Est. completion date: December 2009

Study information

• Verified date: April 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Rehabilitation exercise
Rehab therapy is delivered for 8 weeks.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motor learning behavioral measures; executive function behavioral measures.		Baseline, 8 weeks, 12 weeks	Yes
Secondary	Peak V02 and other aerobic capacity measures. Physical disability measures.		Baseline, 8 weeks, 12 weeks	Yes