Determining Optimal Post-Stroke Exercise (DOSE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01915368 |
Recruitment Status :
Completed
First Posted : August 2, 2013
Last Update Posted : December 16, 2019
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Condition or disease | Intervention/treatment | Phase |
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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 |
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 |
Arm | Intervention/treatment |
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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
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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
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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
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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 |
- Ambulatory function measured by the Six Minute Walk Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) ]
- Ambulatory Function from the Six Minute Walk Test [ Time Frame: 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 ]
- Balance function from the Berg Balance Scale [ Time Frame: 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 ]
- Quality of life measured with EuroQol [ Time Frame: 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 ]
- Cognition measured by the Digit Symbols Substitution Test [ Time Frame: 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 ]
- Depression measured by Patient Health Questionnaire-9 [ Time Frame: 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 ]
- Step count measured during the intervention sessions [ Time Frame: From 10 intervention sessions within the 4-week intervention ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Janice Eng, PhD | The University of British Columbia |
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 |
Exercise Rehabilitation Dose Randomized controlled trial Stroke |
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 |