NCT01067495

Brief Summary

Despite the similarities between heart disease and stroke in terms of disease process and elevated risk of recurrent events, exercise-based programs akin to cardiac rehabilitation are not available for people with stroke. The purpose of this study is to examine 1) the feasibility of adapting cardiac rehabilitation for individuals with stroke, and 2) the effects of this program on aerobic capacity, walking, risk factors, community integration and quality of life. The investigators anticipate that cardiac rehabilitation may be appropriately adapted to accommodate individuals with stroke who have a range of functional abilities, and that this program is effective in improving aerobic capacity, walking ability and stroke risk factors. The investigators also anticipate participants will demonstrate improved community integration and quality of life following this program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Jan 2006

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

January 1, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
Last Updated

February 11, 2010

Status Verified

February 1, 2010

Enrollment Period

3.9 years

First QC Date

February 8, 2010

Last Update Submit

February 10, 2010

Conditions

Keywords

strokerehabilitationexercisewalkingrisk factors

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters)

    Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)

Secondary Outcomes (1)

  • Plasma lipid analysis, questionnaires pertaining to quality of life and community integration

    Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)

Study Arms (1)

Exercise

EXPERIMENTAL
Behavioral: Cardiac rehabilitation

Interventions

Participants will participate in a 6-month cardiac rehabilitation exercise program. This program will include aerobic and resistance training, and education sessions on risk factor management.

Exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chedoke-McMaster Stroke Assessment (CMSA) Scale Leg Score between 3 and 7
  • At least 3 months post-stroke
  • Ability to understand the process and instructions for exercise training and provide informed consent
  • Ability to complete 6-minute walk test

You may not qualify if:

  • Resting blood pressure greater than 160/100 despite medication
  • Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression \> 2 mm, symptomatic aortic stenosis, complex arrhythmias)
  • Unstable angina
  • Orthostatic blood pressure decrease of \> 20 mm Hg with symptoms
  • Hypertrophic cardiomyopathy
  • Other musculoskeletal impairments which would limit the participant's ability to cycle or walk
  • Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
  • Cognitive and/or behavioural issues that would limit participation in exercise testing and training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre

Toronto, Ontario, M4G 1R7, Canada

Location

Related Publications (1)

  • Tang A, Marzolini S, Oh P, McIlroy WE, Brooks D. Feasibility and effects of adapted cardiac rehabilitation after stroke: a prospective trial. BMC Neurol. 2010 Jun 9;10:40. doi: 10.1186/1471-2377-10-40.

MeSH Terms

Conditions

StrokeMotor Activity

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • William E McIlroy, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR
  • Paul Oh, MD

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 11, 2010

Study Start

January 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

February 11, 2010

Record last verified: 2010-02

Locations