NCT00228306

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

3.3 years

First QC Date

September 26, 2005

Last Update Submit

April 27, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Motor learning behavioral measures; executive function behavioral measures.

    Baseline, 8 weeks, 12 weeks

Secondary Outcomes (1)

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

    Baseline, 8 weeks, 12 weeks

Study Arms (2)

1

EXPERIMENTAL
Behavioral: Rehabilitation exercise

2

NO INTERVENTION

Control Group

Interventions

Rehab therapy is delivered for 8 weeks.

1

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Barbara Quaney, PT, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

September 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2009

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations