Determining Optimal Post-Stroke Exercise (DOSE)

December 12, 2019 updated by: Janice Eng, University of British Columbia
The investigators will conduct a proof-of-concept study to provide preliminary evidence of efficacy of physical exercise dose on ambulatory function in adults undergoing sub-acute stroke rehabilitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Participants admitted for stroke rehabilitation will be randomly assigned to either the Stroke Management Group, Stroke Monitoring Group or Stroke Supplementary Group. All three groups will receive usual care, in addition to the intervention. The Stroke Management Group will be provided with periodic information about their progress in the area of mobility using specialized activity monitors. The Stroke Monitoring Group will be progressed according to customized protocols using feedback from specialized activity monitors. The Stroke Supplementary Group will receive the same as the Stroke Monitoring Group, but will also receive one additional hour of daily (5 times per week) physical exercise

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Medical Centre
      • Calgary, Alberta, Canada
        • Fanning Centre
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Surrey Memorial Hospital
      • Surrey, British Columbia, Canada, V3T 4H9
        • Laurel Place
      • Vancouver, British Columbia, Canada, V5Z 2G9
        • GF Strong Rehab Centre
      • Vancouver, British Columbia, Canada
        • Holy Family Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 2P4
        • Riverview Health Centre
    • Ontario
      • Toronto, Ontario, Canada
        • Toronto Rehabilitation Institute

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

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have been admitted to a hospital unit for stroke rehabilitation
  • Within 10 weeks post-stroke
  • 19 years or older
  • Are experiencing difficulty walking

Exclusion Criteria:

  • Requires greater than one person assist for transfer or ambulation
  • Have uncontrolled medical condition or another serious medication condition in addition to stroke
  • Unable to understand or follow directions

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stroke Management Program (SMP)
Participants will have usual care, and in addition, be provided with periodic information about their progress in the area of mobility using specialized activity monitors
Behavioral: Stroke Management Program (SMP)
Participants will have usual care, and in addition, be provided with periodic information about their progress in the area of mobility using specialized activity monitors
Experimental: Stroke Monitoring Program (SMonP)
Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors
Behavioral: Stroke Monitoring Program (SMonP)
Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors
Experimental: Stroke Supplementary Program (SSP)
Participants will have usual care, and in addition, will receive the same as the Stroke Monitoring Group, and also receive one additional hour of daily (5 times per week) physical exercise
Behavioral: Stroke Supplementary Program (SSP)
Participants will have usual care, and in addition, will receive the same as the Stroke Monitoring Group, and also receive one additional hour of daily (5 times per week) physical exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ambulatory function measured by the Six Minute Walk Test
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission)
Rehabilitation discharge (average 4-5 weeks post admission)

Secondary Outcome Measures

Outcome Measure
Time Frame
Ambulatory Function from the Six Minute Walk Test
Time Frame: 6 and 12 months post-stroke
6 and 12 months post-stroke
Ambulatory function from the 5 Meter Walk Test
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Balance function from the Berg Balance Scale
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Ambulatory function from the Functional Ambulation Classification
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Quality of life measured with EuroQol
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Cognition measured by the Montreal Cognitive Assessment
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Cognition measured by the Digit Symbols Substitution Test
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Cognition measured by the Trail Making Test
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Depression measured by Patient Health Questionnaire-9
Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Heart rate measured during the intervention sessions
Time Frame: From 10 intervention sessions within the 4-week intervention
From 10 intervention sessions within the 4-week intervention
Step count measured during the intervention sessions
Time Frame: From 10 intervention sessions within the 4-week intervention
From 10 intervention sessions within the 4-week intervention

Collaborators and Investigators

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

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Janice Eng, PhD, The University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 31, 2013

First Posted (Estimate)

August 2, 2013

Study Record Updates

Last Update Posted (Actual)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-01933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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