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Determining Optimal Post-Stroke Exercise (DOSE)

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ClinicalTrials.gov Identifier: NCT01915368
Recruitment Status : Recruiting
First Posted : August 2, 2013
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):

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
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)

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  (Clinical Trial)
Estimated 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 : September 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) ]

Secondary Outcome Measures :
  1. Ambulatory Function from the Six Minute Walk Test [ Time Frame: 6 and 12 months post-stroke ]
  2. Ambulatory function from the 5 Meter Walk Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke ]
  3. Balance function from the Berg Balance Scale [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ]
  4. Ambulatory function from the Functional Ambulation Classification [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ]
  5. Quality of life measured with EuroQol [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ]
  6. Cognition measured by the Montreal Cognitive Assessment [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ]
  7. Cognition measured by the Digit Symbols Substitution Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke ]
  8. Cognition measured by the Trail Making Test [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke ]
  9. Depression measured by Patient Health Questionnaire-9 [ Time Frame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915368


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

Locations
Canada, Alberta
Fanning Centre Recruiting
Calgary, Alberta, Canada
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@vch.ca   
Foothills Medical Centre Recruiting
Calgary, Alberta, Canada
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@vch.ca   
Canada, British Columbia
Laurel Place Recruiting
Surrey, British Columbia, Canada, V3T 4H9
Contact: Chih-ya Hung, MScPT    6047144108    chihya.hung@ubc.ca   
Principal Investigator: Janice Eng, PhD         
Surrey Memorial Hospital Recruiting
Surrey, British Columbia, Canada, V3V 1Z2
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@ubc.ca   
Principal Investigator: Janice Eng, PhD         
GF Strong Rehab Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: Chihya Hung, MSc    604-714-4108    chihya.hung@vch.ca   
Principal Investigator: Janice Eng, PhD         
Holy Family Hospital Recruiting
Vancovuer, British Columbia, Canada
Contact: Chihya Hung, MScPT    604-714-4108    chihya.hung@vch.ca   
Canada, Manitoba
Riverview Health Centre Recruiting
Winnipeg, Manitoba, Canada, R3L 2P4
Contact: Chihya Hung, MScPT    1-604-714-4117    chihya.hung@ubc.ca   
Canada, Ontario
Toronto Rehabilitation Institute Active, not recruiting
Toronto, Ontario, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Janice Eng, PhD The University of British Columbia
More Information

Responsible Party: Janice Eng, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT01915368     History of Changes
Other Study ID Numbers: H13-01933
First Posted: August 2, 2013    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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