Determining Optimal Post-Stroke Exercise (DOSE)

NCT01915368 | Completed DMC

• 1 other identifier: H13-01933
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 8

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.

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

Outcome Measures

Primary Outcomes (1)

• Ambulatory function measured by the Six Minute Walk Test

  Rehabilitation discharge (average 4-5 weeks post admission)

Secondary Outcomes (11)

• Ambulatory Function from the Six Minute Walk Test

  6 and 12 months post-stroke

• Ambulatory function from the 5 Meter Walk Test

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

• Balance function from the Berg Balance Scale

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

• Ambulatory function from the Functional Ambulation Classification

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

• Quality of life measured with EuroQol

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

Study Arms (3)

Stroke Management Program (SMP)

ACTIVE COMPARATOR

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

Behavioral: Stroke Management Program (SMP)

Stroke Monitoring Program (SMonP)

EXPERIMENTAL

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

Behavioral: Stroke Monitoring Program (SMonP)

Stroke Supplementary Program (SSP)

EXPERIMENTAL

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

Behavioral: Stroke Supplementary Program (SSP)

Interventions

Stroke Management Program (SMP) 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 Management Program (SMP)

Stroke Monitoring Program (SMonP) BEHAVIORAL

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

Stroke Monitoring Program (SMonP)

Stroke Supplementary Program (SSP) 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

Stroke Supplementary Program (SSP)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (8)

Fanning Centre

Calgary, Alberta, Canada

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Laurel Place

Surrey, British Columbia, V3T 4H9, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, V3V 1Z2, Canada

Location

GF Strong Rehab Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Holy Family Hospital

Vancouver, British Columbia, Canada

Location

Riverview Health Centre

Winnipeg, Manitoba, R3L 2P4, Canada

Location

Toronto Rehabilitation Institute

Toronto, Ontario, Canada

Location

Related Publications (7)

• 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. doi: 10.1186/s43058-025-00812-y. Online ahead of print.

  PMID: 41508158 DERIVED

• 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.

  PMID: 37360352 DERIVED

• 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.

  PMID: 34949129 DERIVED

• 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.

  PMID: 32811378 DERIVED

• 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.

  PMID: 31711211 DERIVED

• 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.

  PMID: 30010509 DERIVED

• 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.

  PMID: 28784922 DERIVED

MeSH Terms

Conditions

Stroke; Cerebral Infarction; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Behavior

Study Officials

• Janice Eng, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: August 2, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)