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Determining Optimal Post-Stroke Exercise (DOSE)

Primary Purpose

Cerebrovascular Accident, Stroke, Cerebral Infarction

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Stroke Management Program (SMP)
Stroke Monitoring Program (SMonP)
Stroke Supplementary Program (SSP)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Exercise, Rehabilitation, Dose, Randomized controlled trial, Stroke

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fanning Centre
  • Foothills Medical Centre
  • Laurel Place
  • Surrey Memorial Hospital
  • GF Strong Rehab Centre
  • Holy Family Hospital
  • Riverview Health Centre
  • Toronto Rehabilitation Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Stroke Management Program (SMP)

Stroke Monitoring Program (SMonP)

Stroke Supplementary Program (SSP)

Arm Description

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

Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors

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

Outcomes

Primary Outcome Measures

Ambulatory function measured by the Six Minute Walk Test

Secondary Outcome Measures

Ambulatory Function from the Six Minute Walk Test
Ambulatory function from the 5 Meter Walk Test
Balance function from the Berg Balance Scale
Ambulatory function from the Functional Ambulation Classification
Quality of life measured with EuroQol
Cognition measured by the Montreal Cognitive Assessment
Cognition measured by the Digit Symbols Substitution Test
Cognition measured by the Trail Making Test
Depression measured by Patient Health Questionnaire-9
Heart rate measured during the intervention sessions
Step count measured during the intervention sessions

Full Information

First Posted
July 11, 2013
Last Updated
December 12, 2019
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01915368
Brief Title
Determining Optimal Post-Stroke Exercise (DOSE)
Official Title
Determining Optimal Post-Stroke Exercise (DOSE)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Vascular Diseases
Keywords
Exercise, Rehabilitation, Dose, Randomized controlled trial, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke Management Program (SMP)
Arm Type
Active Comparator
Arm Description
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
Arm Title
Stroke Monitoring Program (SMonP)
Arm Type
Experimental
Arm Description
Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors
Arm Title
Stroke Supplementary Program (SSP)
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Stroke Management Program (SMP)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Stroke Monitoring Program (SMonP)
Intervention Description
Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors
Intervention Type
Behavioral
Intervention Name(s)
Stroke Supplementary Program (SSP)
Intervention Description
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 Measure Information:
Title
Ambulatory function measured by the Six Minute Walk Test
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission)
Secondary Outcome Measure Information:
Title
Ambulatory Function from the Six Minute Walk Test
Time Frame
6 and 12 months post-stroke
Title
Ambulatory function from the 5 Meter Walk Test
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Title
Balance function from the Berg Balance Scale
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Title
Ambulatory function from the Functional Ambulation Classification
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Title
Quality of life measured with EuroQol
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Title
Cognition measured by the Montreal Cognitive Assessment
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Title
Cognition measured by the Digit Symbols Substitution Test
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Title
Cognition measured by the Trail Making Test
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Title
Depression measured by Patient Health Questionnaire-9
Time Frame
Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Title
Heart rate measured during the intervention sessions
Time Frame
From 10 intervention sessions within the 4-week intervention
Title
Step count measured during the intervention sessions
Time Frame
From 10 intervention sessions within the 4-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janice Eng, PhD
Organizational Affiliation
The University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fanning Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Laurel Place
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3T 4H9
Country
Canada
Facility Name
Surrey Memorial Hospital
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
GF Strong Rehab Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 2G9
Country
Canada
Facility Name
Holy Family Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Riverview Health Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3L 2P4
Country
Canada
Facility Name
Toronto Rehabilitation Institute
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34949129
Citation
Peters S, Klassen T, Schneeberg A, Dukelow S, Bayley M, Hill M, Pooyania S, Yao J, Eng J. Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. Neurorehabil Neural Repair. 2022 Feb;36(2):97-102. doi: 10.1177/15459683211062894. Epub 2021 Dec 23.
Results Reference
derived
PubMed Identifier
32811378
Citation
Klassen TD, Dukelow SP, Bayley MT, Benavente O, Hill MD, Krassioukov A, Liu-Ambrose T, Pooyania S, Poulin MJ, Schneeberg A, Yao J, Eng JJ. Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation. Stroke. 2020 Sep;51(9):2639-2648. doi: 10.1161/STROKEAHA.120.029245. Epub 2020 Aug 19.
Results Reference
derived
PubMed Identifier
31711211
Citation
Janssen J, Klassen TD, Connell LA, Eng JJ. Factors Influencing the Delivery of Intensive Rehabilitation in Stroke: Patient Perceptions Versus Rehabilitation Therapist Perceptions. Phys Ther. 2020 Feb 7;100(2):307-316. doi: 10.1093/ptj/pzz159.
Results Reference
derived
PubMed Identifier
30010509
Citation
Klassen TD, Dukelow SP, Bayley MT, Benavente O, Hill MD, Krassioukov A, Liu-Ambrose T, Pooyania S, Poulin MJ, Yao J, Eng JJ. Determining optimal poststroke exercise: Study protocol for a randomized controlled trial investigating therapeutic intensity and dose on functional recovery during stroke inpatient rehabilitation. Int J Stroke. 2019 Jan;14(1):80-86. doi: 10.1177/1747493018785064. Epub 2018 Jul 16.
Results Reference
derived
PubMed Identifier
28784922
Citation
Klassen TD, Semrau JA, Dukelow SP, Bayley MT, Hill MD, Eng JJ. Consumer-Based Physical Activity Monitor as a Practical Way to Measure Walking Intensity During Inpatient Stroke Rehabilitation. Stroke. 2017 Sep;48(9):2614-2617. doi: 10.1161/STROKEAHA.117.018175. Epub 2017 Aug 7.
Results Reference
derived

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Determining Optimal Post-Stroke Exercise (DOSE)

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