Determining Optimal Post-Stroke Exercise (DOSE)

Not Applicable

Completed

• Conditions: Stroke; Vascular Diseases; Cerebrovascular Accident; Brain Infarction; Brain Diseases; Brain Ischemia; Central Nervous System Diseases; Nervous System Diseases; Cerebral Infarction; Cerebrovascular Disorders
• Interventions: Behavioral: Stroke Monitoring Program (SMonP); Behavioral: Stroke Management Program (SMP); Behavioral: Stroke Supplementary Program (SSP)

• Registration Number: NCT01915368
• Lead Sponsor: University of British Columbia

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.

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 Timeline

• Study First Submitted: 2013-07-11
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-02
• Study Start: 2013-09
• Status Verified: 2019-12
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stroke Monitoring Program (SMonP)	Stroke Monitoring Program (SMonP)	Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors
Stroke Management Program (SMP)	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
Stroke Supplementary Program (SSP)	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

Primary Outcome Measures

Name	Time	Method
Ambulatory function measured by the Six Minute Walk Test	Rehabilitation discharge (average 4-5 weeks post admission)

Secondary Outcome Measures

Name	Time	Method
Balance function from the Berg Balance Scale	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
Step count measured during the intervention sessions	From 10 intervention sessions within the 4-week intervention
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
Cognition measured by the Montreal Cognitive Assessment	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
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
Ambulatory function from the Functional Ambulation Classification	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

Trial Locations

Locations (8)

Fanning Centre; 🇨🇦 Calgary, Alberta, Canada

GF Strong Rehab Centre; 🇨🇦 Vancouver, British Columbia, Canada

Riverview Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Laurel Place; 🇨🇦 Surrey, British Columbia, Canada

Surrey Memorial Hospital; 🇨🇦 Surrey, British Columbia, Canada

Holy Family Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Toronto Rehabilitation Institute; 🇨🇦 Toronto, Ontario, Canada