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Cerebrovascular AccidentNCT01915368

Determining Optimal Post-Stroke Exercise (DOSE)

A study testing Stroke Management Program (SMP), Stroke Monitoring Program (SMonP) and Stroke Supplementary Program (SSP) in people with Cerebrovascular Accident and Stroke, run by University of British Columbia at 8 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Stroke Management Program (SMP), Stroke Monitoring Program (SMonP) and Stroke Supplementary Program (SSP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
8 sitesCanada
Study dates
Sep 2013to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have been admitted to a hospital unit for stroke rehabilitation
  • Within 10 weeks post-stroke
  • 19 years or older
  • Are experiencing difficulty walking

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites

  • Fanning Centre

    Calgary, Alberta

  • Foothills Medical Centre

    Calgary, Alberta

  • Laurel Place

    Surrey, British Columbia, V3T 4H9

  • Surrey Memorial Hospital

    Surrey, British Columbia, V3V 1Z2

  • Toronto Rehabilitation Institute

    Toronto, Ontario

  • GF Strong Rehab Centre

    Vancouver, British Columbia, V5Z 2G9

  • Holy Family Hospital

    Vancouver, British Columbia

  • Riverview Health Centre

    Winnipeg, Manitoba, R3L 2P4

Other trials in Canada

About this study

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.

Read the 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

Being tested
Stroke Management Program (SMP), Stroke Monitoring Program (SMonP), Stroke Supplementary Program (SSP)
Keywords
Exercise, Rehabilitation, Dose, Randomized controlled trial, Stroke
Medical subject headings
Stroke, Cerebral Infarction, Brain Infarction, Brain Ischemia, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stroke Management Program (SMP)Behavioural

    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)Behavioural

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

  • Stroke Supplementary Program (SSP)Behavioural

    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

Study groups in NCT01915368
Study groupRoleWhat they receive
Stroke Management Program (SMP)Active comparatorParticipants will have usual care, and in addition, be provided with periodic information about their progress in the area of mobility using specialized activity monitors
Receives: Behavioral: Stroke Management Program (SMP)
Stroke Monitoring Program (SMonP)ExperimentalParticipants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors
Receives: Behavioral: Stroke Monitoring Program (SMonP)
Stroke Supplementary Program (SSP)ExperimentalParticipants 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
Receives: Behavioral: Stroke Supplementary Program (SSP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ambulatory function measured by the Six Minute Walk Test

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

Secondary outcomes (11)

  1. Ambulatory Function from the Six Minute Walk Test

    Measured: 6 and 12 months post-stroke

  2. Ambulatory function from the 5 Meter Walk Test

    Measured: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke

  3. Balance function from the Berg Balance Scale

    Measured: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke

  4. Ambulatory function from the Functional Ambulation Classification

    Measured: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke

  5. Quality of life measured with EuroQol

    Measured: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke

  6. Cognition measured by the Montreal Cognitive Assessment

    Measured: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke

  7. Cognition measured by the Digit Symbols Substitution Test

    Measured: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke

  8. Cognition measured by the Trail Making Test

    Measured: Rehabilitation discharge (average 4-5 weeks post admission), 6 and 12 months post-stroke

  9. Depression measured by Patient Health Questionnaire-9

    Measured: Rehabilitation discharge (average 4-5 weeks post admission) , 6 and 12 months post-stroke

  10. Heart rate measured during the intervention sessions

    Measured: From 10 intervention sessions within the 4-week intervention

  11. Step count measured during the intervention sessions

    Measured: From 10 intervention sessions within the 4-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01915368
Sponsor's protocol ID
H13-01933
Status last verified
Dec 2019
First submitted
11 Jul 2013
Last updated
16 Dec 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Ackerley S, Hung SH, Sheehy L, Donkers SJ, Timofeeva P, Best KL, Peters S, Park SS, Ouellet B, Ezeugwu VE, Milot MH, Sakakibara BM, Eng JJ, Connell LA. Exploring factors influencing implementation across the explanatory-to-pragmatic trial continuum: a sequential qualitative integration of delivering higher-intensity walking exercise within inpatient stroke rehabilitation. Implement Sci Commun. 2026 Jan 8;7(1):44. doi: 10.1186/s43058-025-00812-y.

    PubMed 41508158

  • Peters S, Lohse KR, Klassen TD, Liu-Ambrose T, Dukelow SP, Bayley MT, Hill MD, Pooyania S, Yao J, Eng JJ. Higher intensity walking improves global cognition during inpatient rehabilitation: a secondary analysis of a randomized control trial. Front Neurol. 2023 Jun 9;14:1023488. doi: 10.3389/fneur.2023.1023488. eCollection 2023.

    PubMed 37360352

  • 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.

    PubMed 34949129

  • 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.

    PubMed 32811378

  • 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.

    PubMed 31711211

  • 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.

    PubMed 30010509

  • 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.

    PubMed 28784922

Questions about this trial

What is this clinical trial studying?

A study testing Stroke Management Program (SMP), Stroke Monitoring Program (SMonP) and Stroke Supplementary Program (SSP) in people with Cerebrovascular Accident and Stroke, run by University of British Columbia at 8 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ambulatory function measured by the Six Minute Walk Test (time frame: Rehabilitation discharge (average 4-5 weeks post admission)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01915368, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2019.

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