Clinical trial NCT01915368: Determining Optimal Post-Stroke Exercise (DOSE)
Official title: Determining Optimal Post-Stroke Exercise (DOSE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Accident
Stroke
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Keywords: Exercise
Rehabilitation
Dose
Randomized controlled trial
Stroke
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Ambulatory function measured by the Six Minute Walk Test
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission)
Secondary outcomes:
measure: Ambulatory Function from the Six Minute Walk Test
timeFrame: 6 and 12 months post-stroke
measure: Ambulatory function from the 5 Meter Walk Test
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
measure: Balance function from the Berg Balance Scale
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
measure: Ambulatory function from the Functional Ambulation Classification
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
measure: Quality of life measured with EuroQol
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
measure: Cognition measured by the Montreal Cognitive Assessment
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
measure: Cognition measured by the Digit Symbols Substitution Test
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
measure: Cognition measured by the Trail Making Test
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke
measure: Depression measured by Patient Health Questionnaire-9
timeFrame: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke
measure: Heart rate measured during the intervention sessions
timeFrame: From 10 intervention sessions within the 4-week intervention
measure: Step count measured during the intervention sessions
timeFrame: From 10 intervention sessions within the 4-week intervention
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Fanning Centre
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Surrey
country: Canada
facility: Laurel Place
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: GF Strong Rehab Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Holy Family Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Riverview Health Centre
state: Manitoba
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: The University of British Columbia
name: Janice Eng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peters S, Klassen T, Schneeberg A, Dukelow S, Bayley M, Hill M, Pooyania S, Yao J, Eng J. Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. Neurorehabil Neural Repair. 2022 Feb;36(2):97-102. doi: 10.1177/15459683211062894. Epub 2021 Dec 23.
citation: Klassen TD, Dukelow SP, Bayley MT, Benavente O, Hill MD, Krassioukov A, Liu-Ambrose T, Pooyania S, Poulin MJ, Schneeberg A, Yao J, Eng JJ. Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation. Stroke. 2020 Sep;51(9):2639-2648. doi: 10.1161/STROKEAHA.120.029245. Epub 2020 Aug 19.
citation: Janssen J, Klassen TD, Connell LA, Eng JJ. Factors Influencing the Delivery of Intensive Rehabilitation in Stroke: Patient Perceptions Versus Rehabilitation Therapist Perceptions. Phys Ther. 2020 Feb 7;100(2):307-316. doi: 10.1093/ptj/pzz159.
citation: Klassen TD, Dukelow SP, Bayley MT, Benavente O, Hill MD, Krassioukov A, Liu-Ambrose T, Pooyania S, Poulin MJ, Yao J, Eng JJ. Determining optimal poststroke exercise: Study protocol for a randomized controlled trial investigating therapeutic intensity and dose on functional recovery during stroke inpatient rehabilitation. Int J Stroke. 2019 Jan;14(1):80-86. doi: 10.1177/1747493018785064. Epub 2018 Jul 16.
citation: Klassen TD, Semrau JA, Dukelow SP, Bayley MT, Hill MD, Eng JJ. Consumer-Based Physical Activity Monitor as a Practical Way to Measure Walking Intensity During Inpatient Stroke Rehabilitation. Stroke. 2017 Sep;48(9):2614-2617. doi: 10.1161/STROKEAHA.117.018175. Epub 2017 Aug 7.