Determining Optimal Post-Stroke Exercise (DOSE)

NCT ID: NCT01915368

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Exercise Rehabilitation Dose Randomized controlled trial Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stroke 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

Group Type ACTIVE_COMPARATOR

Stroke Management Program (SMP)

Intervention Type 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)

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

Group Type EXPERIMENTAL

Stroke Monitoring Program (SMonP)

Intervention Type 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)

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

Group Type EXPERIMENTAL

Stroke Supplementary Program (SSP)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Stroke 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

Intervention Type BEHAVIORAL

Stroke Monitoring Program (SMonP)

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

Intervention Type BEHAVIORAL

Stroke 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Janice Eng

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Janice Eng, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fanning Centre

Calgary, Alberta, Canada

Site Status

Foothills Medical Centre

Calgary, Alberta, Canada

Site Status

Laurel Place

Surrey, British Columbia, Canada

Site Status

Surrey Memorial Hospital

Surrey, British Columbia, Canada

Site Status

GF Strong Rehab Centre

Vancouver, British Columbia, Canada

Site Status

Holy Family Hospital

Vancouver, British Columbia, Canada

Site Status

Riverview Health Centre

Winnipeg, Manitoba, Canada

Site Status

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37360352 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34949129 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32811378 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31711211 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30010509 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28784922 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H13-01933

Identifier Type: -

Identifier Source: org_study_id