The Effect of Aerobic Exercise on Learning After Stroke | NCT00228306

Studies
The Effect of Aerobic Exercise on Learning After Stroke

NCT00228306

Sponsor

University of Kansas

Status

Completed

Last Update Posted

May 1, 2012Estimated

Enrollment

38Actual

Phase

Phase 1

Conditions

Stroke

Interventions

Rehabilitation exercise

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Am Heart Assn 0530208N

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2009Actual

First Submitted Date

Sep 26, 2005

First Submission Date that Met QC Criteria

Sep 26, 2005

First Posted Date

Sep 28, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2012

Last Update Posted Date

May 1, 2012Estimated

Name	Class
American Heart Association	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Behavioral: Rehabilitation exercise
2	No Intervention	Control Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rehabilitation exercise	Behavioral	Rehab therapy is delivered for 8 weeks.	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara Quaney, PT, PhD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005081	Exercise Therapy

Ancestor Terms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided