Determining Optimal Post-Stroke Exercise (DOSE)

Recruiting

Phase N/A Results N/A

Trial Description

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

Conditions

Interventions

  • Stroke Management Program (SMP) Behavioral
    Intervention Desc: 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 1: Kind: Experimental
    Label: Stroke Management Program (SMP)
    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
  • Stroke Monitoring Program (SMonP) Behavioral
    Intervention Desc: Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors
    ARM 1: Kind: Experimental
    Label: Stroke Monitoring Program (SMonP)
    Description: 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
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Stroke Supplementary Program (SSP)
    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

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

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

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