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Determining Optimal Post-Stroke Exercise (DOSE)

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ClinicalTrials.gov Identifier: NCT01915368
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : December 16, 2019
Sponsor:
Information provided by (Responsible Party):
Janice Eng, University of British Columbia

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Stroke Cerebral Infarction Brain Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Behavioral: Stroke Management Program (SMP) Behavioral: Stroke Monitoring Program (SMonP) Behavioral: Stroke Supplementary Program (SSP) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Determining Optimal Post-Stroke Exercise (DOSE)
Study Start Date : September 2013
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Ambulatory function measured by the Six Minute Walk Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) ]

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

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915368


Locations
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Canada, Alberta
Fanning Centre
Calgary, Alberta, Canada
Foothills Medical Centre
Calgary, Alberta, Canada
Canada, British Columbia
Laurel Place
Surrey, British Columbia, Canada, V3T 4H9
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V 1Z2
GF Strong Rehab Centre
Vancouver, British Columbia, Canada, V5Z 2G9
Holy Family Hospital
Vancouver, British Columbia, Canada
Canada, Manitoba
Riverview Health Centre
Winnipeg, Manitoba, Canada, R3L 2P4
Canada, Ontario
Toronto Rehabilitation Institute
Toronto, Ontario, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Janice Eng, PhD The University of British Columbia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janice Eng, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01915368    
Other Study ID Numbers: H13-01933
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Janice Eng, University of British Columbia:
Exercise
Rehabilitation
Dose
Randomized controlled trial
Stroke
Additional relevant MeSH terms:
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Stroke
Nervous System Diseases
Cerebral Infarction
Brain Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Brain Ischemia
 Brain Infarction
Vascular Diseases
Infarction
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis