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Completed

NCT Number: NCT01915368

Determining Optimal Post-Stroke Exercise (DOSE)

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.

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Key information

Conditions

Cerebrovascular Accident Behavior Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Ischemia Motor Activity Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fanning Centre, Calgary, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stroke Management Program (SMP)

Behavioral

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)

Behavioral

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

Stroke Supplementary Program (SSP)

Behavioral

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 outcomes

  1. Ambulatory function measured by the Six Minute Walk Test

    Time frame: Rehabilitation discharge (average 4-5 weeks post admission)

Secondary outcomes

  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

  10. Heart rate measured during the intervention sessions

    Time frame: From 10 intervention sessions within the 4-week intervention

  11. Step count measured during the intervention sessions

    Time frame: From 10 intervention sessions within the 4-week intervention

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2013
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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