Determining Optimal Post-Stroke Exercise (DOSE)

Stroke Clinical Trial

Official title:

Determining Optimal Post-Stroke Exercise (DOSE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915368
• Other study ID #: H13-01933
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Infarction
• Brain Ischemia
• Central Nervous System Diseases
• Cerebral Infarction
• Cerebrovascular Accident
• Cerebrovascular Disorders
• Infarction
• Nervous System Diseases
• Stroke
• Vascular Diseases

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