Determining Optimal Post-Stroke Exercise (DOSE)

• Sponsor: University of British Columbia (Other)
• Overall Status: Completed
• CT.gov ID: NCT01915368
• Collaborator: (none)
• Enrollment: 75
• Locations: 8
• Arms: 3
• Duration (Months): 75
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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)	N/A

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 Design

• Study Type: Interventional
• 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: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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	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	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	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

Outcome Measures

Primary Outcome Measures

1. Ambulatory function measured by the Six Minute Walk Test [Rehabilitation discharge (average 4-5 weeks post admission)]

Secondary Outcome Measures

1. Ambulatory Function from the Six Minute Walk Test [6 and 12 months post-stroke]

2. Ambulatory function from the 5 Meter Walk Test [Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke]

3. Balance function from the Berg Balance Scale [Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke]

4. Ambulatory function from the Functional Ambulation Classification [Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke]

5. Quality of life measured with EuroQol [Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke]

6. Cognition measured by the Montreal Cognitive Assessment [Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke]

7. Cognition measured by the Digit Symbols Substitution Test [Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke]

8. Cognition measured by the Trail Making Test [Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke]

9. Depression measured by Patient Health Questionnaire-9 [Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke]

10. Heart rate measured during the intervention sessions [From 10 intervention sessions within the 4-week intervention]

11. Step count measured during the intervention sessions [From 10 intervention sessions within the 4-week intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fanning Centre	Calgary	Alberta	Canada
2	Foothills Medical Centre	Calgary	Alberta	Canada
3	Laurel Place	Surrey	British Columbia	Canada	V3T 4H9
4	Surrey Memorial Hospital	Surrey	British Columbia	Canada	V3V 1Z2
5	GF Strong Rehab Centre	Vancouver	British Columbia	Canada	V5Z 2G9
6	Holy Family Hospital	Vancouver	British Columbia	Canada
7	Riverview Health Centre	Winnipeg	Manitoba	Canada	R3L 2P4
8	Toronto Rehabilitation Institute	Toronto	Ontario	Canada

Sponsors and Collaborators

• University of British Columbia

Investigators

• Principal Investigator: Janice Eng, PhD, The University of British Columbia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Janice Eng, Principal Investigator, University of British Columbia
• ClinicalTrials.gov Identifier: NCT01915368
• Other Study ID Numbers: H13-01933
• First Posted: Aug 2, 2013
• Last Update Posted: Dec 16, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Janice Eng, Principal Investigator, University of British Columbia: Exercise; Rehabilitation; Dose; Randomized controlled trial; Stroke
• Additional relevant MeSH terms: Stroke; Nervous System Diseases; Cerebral Infarction; Brain Diseases; Central Nervous System Diseases; Cerebrovascular Disorders; Brain Ischemia; Brain Infarction; Vascular Diseases; Infarction

Study Results

No Results Posted as of Dec 16, 2019