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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01915368
Other study ID # H13-01933
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2013
Est. completion date December 2019

Study information

Verified date December 2019
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Intervention

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
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 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

Locations

Country Name City State
Canada Fanning Centre Calgary Alberta
Canada Foothills Medical Centre Calgary Alberta
Canada Laurel Place Surrey British Columbia
Canada Surrey Memorial Hospital Surrey British Columbia
Canada Toronto Rehabilitation Institute Toronto Ontario
Canada GF Strong Rehab Centre Vancouver British Columbia
Canada Holy Family Hospital Vancouver British Columbia
Canada Riverview Health Centre Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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