The Effect of Aerobic Exercise on Learning After Stroke

April 27, 2012 updated by: University of Kansas

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Motor learning behavioral measures; executive function behavioral measures.
Time Frame: Baseline, 8 weeks, 12 weeks
Baseline, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak V02 and other aerobic capacity measures. Physical disability measures.
Time Frame: Baseline, 8 weeks, 12 weeks
Baseline, 8 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas

Collaborators

American Heart Association

Investigators

  • Principal Investigator: Barbara Quaney, PT, PhD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

September 26, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 28, 2005

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9903 (Other Identifier: CTEP)
  • Am Heart Assn 0530208N

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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