Determining Optimal Post-Stroke Exercise (DOSE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01915368
First received: July 11, 2013
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Determining Optimal Post-Stroke Exercise (DOSE)

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Ambulatory function measured by the Six Minute Walk Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ambulatory Function from the Six Minute Walk Test [ Time Frame: 6 and 12 months post-stroke ] [ Designated as safety issue: No ]
  • Ambulatory function from the 5 Meter Walk Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke ] [ Designated as safety issue: No ]
  • Balance function from the Berg Balance Scale [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ] [ Designated as safety issue: No ]
  • Ambulatory function from the Functional Ambulation Classification [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ] [ Designated as safety issue: No ]
  • Functional level measured by the Functional Independence Measure [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) ] [ Designated as safety issue: No ]
  • Quality of life measured with EuroQol [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ] [ Designated as safety issue: No ]
  • Cognition measured by the Montreal Cognitive Assessment [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ] [ Designated as safety issue: No ]
  • Cognition measured by the Digit Symbols Substitution Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke ] [ Designated as safety issue: No ]
  • Cognition measured by the Trail Making Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ] [ Designated as safety issue: No ]
  • Depression measured by Patient Health Questionnaire-9 [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been admitted to a hospital unit for stroke rehabilitation
  • Within 4 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01915368

Contacts
Contact: Chihya Hung, MScPT 604-714-4108 chihya.hung@vch.ca

Locations
Canada, Alberta
Fanning Centre Not yet recruiting
Calgary, Alberta, Canada
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@vch.ca   
Foothills Medical Centre Not yet recruiting
Calgary, Alberta, Canada
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@vch.ca   
Canada, British Columbia
GF Strong Rehab Centre Recruiting
Vancouver, British Columbia, Canada
Contact: Chihya Hung, MSc    604-714-4108    chihya.hung@vch.ca   
Principal Investigator: Janice Eng, PhD         
Holy Family Hospital Not yet recruiting
Vancovuer, British Columbia, Canada
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@vch.ca   
Canada, Ontario
Toronto Rehabilitation Institute Not yet recruiting
Toronto, Ontario, Canada
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@vch.ca   
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Janice Eng, PhD The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01915368     History of Changes
Other Study ID Numbers: H13-01933
Study First Received: July 11, 2013
Last Updated: June 11, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Exercise
Rehabilitation
Dose
Randomized controlled trial
Stroke

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Cerebral Infarction
Stroke
Brain Ischemia
Cerebrovascular Disorders
Infarction
Ischemia
Nervous System Diseases
Vascular Diseases
Brain Infarction
Cardiovascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 28, 2014