Power Exercise for Stroke Recovery: The POWER Pilot Trial (POWER-P)

NCT06780995 | Recruiting

• 1 other identifier: POWER-Pilot
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Weakness is one of the most common consequences of stroke. For the over 750,000 Canadians living with stroke, many daily activities like standing from a chair, walking and balance not only require strength but often efforts in bursts, known as muscle power. Strength training can improve muscle strength and, when performed at higher speeds, can help build muscle power. Current guidelines for stroke recommend strength training but these are commonly performed at lower intensities and do not include any focus on building muscle power. There has been very little research on power training after stroke. A 10-week power training program for people living with stroke, Power Exercise for Stroke Recovery (POWER-Feasibility, NCT05816811) was recently evaluated. POWER includes 3 phases of progressive exercise: building familiarity with the upper and lower body exercises, then strength, and lastly muscle power. The results from POWER-Feasibility are promising, suggesting that POWER is safe and may improve stroke recovery. POWER-Feasibility was a small study (15 participants), and POWER was not compared to a control intervention. A pilot randomized controlled trial of POWER (POWER-Pilot) will now be conducted. Sixty people who are at least 6 months after stroke will be recruited. They will be randomly assigned to participate in POWER or standard strength training for stroke at lower intensities and without focus on power training. The feasibility of a randomized study will be examined, and whether POWER can improve walking, strength and balance compared to the control group. Results from POWER-Pilot will help design a larger randomized trial in the future (POWER-RCT), and may ultimately be important for stroke rehabilitation teams to better understand whether power training can help people recovering from stroke.

Conditions

Stroke

Keywords

Stroke; Aging; Resistance training; Power training; Physical function; Community exercise; Quality of life; Rehabilitation

Outcome Measures

Primary Outcomes (12)

• Feasibility: Randomization - Percentage of participants allocated as assigned

  Indicator: Yes/No; Criteria for success and progression: Success: 100% participants allocated as assigned, Revise: \<100% participants allocated as assigned

  Through study completion, over 24 months

• Feasibility: Randomization - Clinically important difference between groups

  Indicator: Balance of prognosis; Criteria for success and progression: Success: No clinically important differences between groups, Revise: Clinically important differences between groups

  Through study completion, over 24 months

• Feasibility: Allocation concealment

  Indicator: Yes/No; Criteria for success and progression: Success: Allocation concealment preserved, Revise: Allocation revealed

  Through study completion, over 24 months

• Feasibility: Assessor blinding - Number of occurrences of unblinding

  Indicator: # occurrences of unblinding; Criteria for success and progression: Success: Assessors unblinded for \<5% of participants, Revise: Assessors unblinded for ≥5% of participants

  Through study completion, over 24 months

• Feasibility: Contamination - Number of participants exposed to other intervention arm

  Indicator: # participants exposed to the other intervention arm; Criteria for success and progression: Success: No occurrences of contamination, Revise: Any occurrence of contamination

  Through study completion, over 24 months

• Feasibility: Recruitment rate - Number of participants recruited per month

  Indicator: # recruited / month; Criteria for success and progression: Success: Mean 1.0 participants/month/site, Revise: Mean \<1.0 participants/month/site

  Through study completion, over 24 months

• Feasibility: Retention rate - Percentage of participants with follow up data

  Indicator: % follow up data; Criteria for success and progression: Success: Complete follow up data in ≥80% participants, Revise: Complete follow up data in \<80% participants

  Through study completion, over 24 months

• Feasibility: Participant and assessor burden - Percentage of participants completing study assessments in ≤1.5h

  Indicator: time to complete assessments; Criteria for success and progression: Success: ≥80% complete assessments in ≤1.5h, Revise: \<80% complete assessments in ≤1.5h

  Through study completion, over 24 months

• Feasibility: Participant and assessor burden - Participant rating of the burden of assessments

  Indicator: perceived burden of assessments; Criteria for success and progression: Success: Rating ≤3 on 10-point Likert scale (1=not at all; 10=extremely burdensome), Revise: Rating \>3 out of 10

  Through study completion, over 24 months

• Feasibility: Safety - Number of serious adverse events

  Indicator: Serious adverse events from assessments or interventions; Criteria for success and progression: Success: 0 occurrences, Revise: Any occurrences

  Through study completion, over 24 months

• Feasibility: Treatment effect - Availability of clinical outcome data

  Indicator: Number of available data points at post-intervention; Criteria for success and progression: ≥90% (n=54/60) data available on all clinical outcomes of interest

  Through study completion, over 24 months

• Functional mobility: Timed Up and Go (TUG) test (self- and fast-paced)

  The Timed Up and Go is a measure of functional mobility. A standard chair (\~46cm in height) will be placed at the start of a flat walking course and a cone will be placed 3 meters from the chair. Participants will stand from the chair, walk 3 meters, turn back towards the chair, and sit back down, without assistance. This will be completed at a comfortable pace and fast pace. The task will be timed and measured in seconds, a shorter time indicates better mobility and balance.

  Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks)

Secondary Outcomes (13)

• Walking speed: 10-meter walking speed (self- and fast-paced)

  Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks)

• Post-stroke fatigue: Fatigue Severity Scale-7 (FFS)

  Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks)

• Psychological well-being: General Health Questionnaire-28

  Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks)

• Cognition: Montreal Cognitive Assessment (MoCA)

  Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks)

• Standing balance: Brief Balance Evaluation System Test (Brief BESTest)

  Baseline (0 weeks), post-intervention (10 weeks), follow-up (18 weeks)

Study Arms (2)

Power Exercise for Stroke Recovery (POWER)

EXPERIMENTAL

POWER involves 3 progressive phases: 1) Familiarization (1 week), 2) Strength (4 weeks, 2-3 sets, 5-8 repetitions), and 3) Power (5 weeks, 2-3 sets, 15-20 repetitions, fast tempo).

Other: Power Exercise for Stroke Recovery (POWER)

Strength Training Engaging Guidelines to Enhance Total Health (STRENGTH)

ACTIVE COMPARATOR

STRENGTH is based on current resistance exercise training (RET) clinical practice guidelines for stroke with no focus on power.

Other: Strength Training Engaging Guidelines to Enhance Total Health (STRENGTH)

Interventions

Strength Training Engaging Guidelines to Enhance Total Health (STRENGTH) OTHER

STRENGTH is based on current clinical practice guidelines for RET after stroke. It will include the same Familiarization week as the POWER program (Week 1), followed by progressive conventional RET involving 3 sets of 10-15 repetitions at moderate to high intensities (RPE 4-5 "Somewhat hard" to "Hard") (Weeks 2-10). The external resistance will be progressed to maintain this target RPE range. STRENGTH is matched with POWER in length (60-minute sessions over 10 weeks), frequency (3x/week) and format (in-person supervision).

Strength Training Engaging Guidelines to Enhance Total Health (STRENGTH)

Power Exercise for Stroke Recovery (POWER) OTHER

POWER incorporates 3 progressive phases: Phase 1 Familiarization (Week 1) as a low-intensity version of the training program to acclimate participants to the movements (body weight resisted or light weights, RPE 2-3 "Fairly light" to "Moderate"). Phase 2 Strength (Weeks 2-5) progresses loads to achieve volitional fatigue within 6-8 repetitions (RPE 7-9 "Very hard" to "Very very hard"). Phase 3 Power (Weeks 6-10) will use intensities RPE 4-6 ("Somewhat hard" to "Very hard"), and exercises will be executed at the highest possible velocity to focus on muscle power. The Power phase is intentionally designed with exercises to emphasize functional movements such as fast sit to stands, lunging and calf raises.

Power Exercise for Stroke Recovery (POWER)

Eligibility Criteria

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

You may qualify if:

• ≥19 years old
• ≥6 months poststroke,
• able to walk \>10 meters with or without an assistive device
• have mild to moderate stroke severity (modified Rankin Scale ≤3)
• without significant cognitive impairment that would preclude safe exercise, screened via Montreal Cognitive Assessment-Blind score \<18

You may not qualify if:

• Any contraindications to exercise for people with cardiovascular disease, such as unstable angina, uncontrolled hypertension, orthostatic blood pressure with exercise, or uncontrolled arrhythmias or
• Actively engaged in or have made plans to engage in stroke rehabilitation services

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

The University of British Columbia - Okanagan Campus

Kelowna, British Columbia, V1V 1V7, Canada

RECRUITING

McMaster University

Hamilton, Ontario, L8S1C7, Canada

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ada Tang, PT PhD

CONTACT

289-426-5768; atang@mcmaster.ca

Hanna Fang

CONTACT

289-426-0468; fangh@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assistant Dean

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: January 17, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

CA (2)