The Effect of Aerobic Exercise on Learning After Stroke

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Rehabilitation exercise

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Control Group

Outcomes

Primary Outcome Measures

Motor learning behavioral measures; executive function behavioral measures.

Secondary Outcome Measures

Peak V02 and other aerobic capacity measures. Physical disability measures.

Full Information

NCT ID

NCT00228306

First Posted

September 26, 2005

Last Updated

April 27, 2012

Sponsor

University of Kansas

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT00228306

Brief Title

The Effect of Aerobic Exercise on Learning After Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Kansas

Collaborators

American Heart Association

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Experimental

Arm Title

2

Arm Type

No Intervention

Arm Description

Control Group

Intervention Type

Behavioral

Intervention Name(s)

Rehabilitation exercise

Intervention Description

Rehab therapy is delivered for 8 weeks.

Primary Outcome Measure Information:

Title

Motor learning behavioral measures; executive function behavioral measures.

Time Frame

Baseline, 8 weeks, 12 weeks

Secondary Outcome Measure Information:

Title

Peak V02 and other aerobic capacity measures. Physical disability measures.

Time Frame

Baseline, 8 weeks, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara Quaney, PT, PhD

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Stroke

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial