Determining Optimal Post-Stroke Exercise (DOSE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Determining Optimal Post-Stroke Exercise (DOSE)

Conditions
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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

Intervention / Treatment
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* Behavioral: Stroke Management Program (SMP)
* Behavioral: Stroke Monitoring Program (SMonP)
* Behavioral: Stroke Supplementary Program (SSP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stroke Management Program (SMP)<br>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)<br>* 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<br>|
| Experimental: Stroke Monitoring Program (SMonP)<br>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)<br>* Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors<br>|
| Experimental: Stroke Supplementary Program (SSP)<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Rehabilitation, Dose, Randomized controlled trial, Stroke