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Determining Optimal Post-Stroke Exercise (DOSE)

Determining Optimal Post-Stroke Exercise (DOSE)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01915368
Enrollment
75
Registered
2013-08-02
Start date
2013-09-30
Completion date
2019-12-31
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Diseases, Brain Infarction, Brain Ischemia, Central Nervous System Diseases, Cerebral Infarction, Cerebrovascular Accident, Cerebrovascular Disorders, Nervous System Diseases, Stroke, Vascular Diseases

Keywords

Exercise, Rehabilitation, Dose, Randomized controlled trial, Stroke

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

Interventions

BEHAVIORALStroke 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

BEHAVIORALStroke Monitoring Program (SMonP)

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

BEHAVIORALStroke 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

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Ambulatory function measured by the Six Minute Walk TestRehabilitation discharge (average 4-5 weeks post admission)

Secondary

MeasureTime frame
Ambulatory function from the 5 Meter Walk TestRehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Balance function from the Berg Balance ScaleRehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Ambulatory function from the Functional Ambulation ClassificationRehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Quality of life measured with EuroQolRehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Cognition measured by the Montreal Cognitive AssessmentRehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Ambulatory Function from the Six Minute Walk Test6 and 12 months post-stroke
Cognition measured by the Trail Making TestRehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
Depression measured by Patient Health Questionnaire-9Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
Heart rate measured during the intervention sessionsFrom 10 intervention sessions within the 4-week intervention
Step count measured during the intervention sessionsFrom 10 intervention sessions within the 4-week intervention
Cognition measured by the Digit Symbols Substitution TestRehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026