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Completed

NCT Number: NCT05816811

Power Exercise for Stroke Recovery: The POWER Feasibility Trial

Post-stroke deficits are highly common and functional impairment persists throughout life after stroke. Skeletal muscle mass and strength are fundamental contributors to mobility throughout the adult life course. Stroke-related muscle atrophy contributes to loss of strength, and declines in lower extremity function, cardiorespiratory fitness, and walking independence and post-stroke sarcopenia. Improving the quantity and function of skeletal muscle needs to be an important therapeutic target after stroke. Resistance exercise training (RET) has been shown to increase skeletal muscle mass, strength and power, reduce oxidative stress, improve cardiac function, and better regulate lipids after stroke. However, the feasibility and the effects of a power focused RET program for individuals with stroke need to be examined.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Rehabilitation Science

Hamilton, Ontario, L8S1C7, Canada

About this study

This study is a single-group, open label trial examining the feasibility and preliminary effect estimates of a 10-week power-focused exercise training program in people living with stroke. Fifteen participants with chronic stroke will participate in the exercise program 3 times per week for 10 weeks at a progressive intensity. The program will take place at a community exercise gym built for older adults and people with physical disabilities. Feasibility outcomes will be assessed throughout the trial. Effectiveness outcomes will be assessed at baseline and immediately post-intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old
  • ≥6 months post-stroke
  • Able to walk >10 meters with or without the use of an assistive device
  • Living in the community
  • Mild to moderate stroke severity (modified Rankin Scale ≤3)

Exclusion criteria

  • Any contraindications to exercise for people with cardiovascular disease, such as unstable angina, uncontrolled hypertension, orthostatic blood pressure with exercise, or uncontrolled arrhythmias
  • Significant cognitive impairment that would preclude safe exercise participation (Montreal Cognitive Assessment score <26)
  • Actively engaged in stroke rehabilitation services

Treatment and study plan

Power-focused resistance training

Other

Participants will undergo 10 weeks of power-focused resistance training.

Other names: Power training

Primary outcomes

  1. Feasibility: Participant recruitment

    Time frame: Through study completion, over 13 months

    Recruitment rates (n/week) and the number of recruited subjects (n) will be reported. Criteria for success include recruitment of ≥1 participant per month and n=15 recruited in ≤13 months.

  2. Feasibility: Sex and gender distribution

    Time frame: Through study completion, over 13 months

    Recruitment of males and females, men, women and gender diverse participants will be recorded (n, %). Criteria for success is <60% (n<9) of any sex or gender identity.

  3. Feasibility: Attendance and attrition

    Time frame: Through study completion, over 13 months

    Percentage of sessions attended (%) and lost to follow-up (n) will be reported. Criteria for success includes ≥85% sessions attended and ≤10% (n<2) lost to follow-up.

  4. Feasibility: Serious and non-serious adverse events

    Time frame: Through study completion, over 13 months

    Number of adverse events (i.e., deaths, serious and non-serious adverse events, n) will be reported. Criteria for success is 0 deaths or serious adverse events and <5 non-serious adverse events.

  5. Feasibility: Exercise tolerance

    Time frame: Through study completion, over 13 months

    Adherence to the prescribed exercises (%) and abnormal blood pressure responses to exercise (n) will be recorded. Criteria for success includes ≥85 of participants performing ≥85% of sets at the prescribed intensity, and ≤25% of weeks experiencing ≥1 abnormal blood pressure response (SBP ≥210 or ≥190 for males and females, respectively).

  6. Feasibility: Satisfaction

    Time frame: Immediately post-intervention (week 10)

    Satisfaction will be measured with a 5-point Likert scale (1 = not at all satisfied, 2 = not satisfied, 3 = neither satisfied or not satisfied, 4 = satisfied, and 5 = completely satisfied). Criteria for success is ≥85% of participants reporting being satisfied or completely satisfied with the program.

Secondary outcomes

  1. Timed up and go test

    Time frame: Baseline (week 0) and post-intervention (week 10)

    The TUG 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. The task will be timed and measured in seconds.

  2. Short physical performance battery

    Time frame: Baseline (week 0) and post-intervention (week 10)

    The SPPB involves 3 tests, each measuring different constructs of physical function: (1) balance (tandem stand test), (2) walking ability (4-meter walk test), and (3) lower-limb strength and endurance (5-times sit to stand test). Two trained study staff members will concurrently assess each measure. Each test on the SPPB is scored separately on a scale ranging from 0 to 4, per instrument scoring guidelines. Raw and SPPB scores will be measured.

  3. 30-second chair stand test

    Time frame: Baseline (week 0) and post-intervention (week 10)

    The 30sCST is a measure of lower extremity strength and endurance. A ~43cm chair with a straight back and no armrests will be placed against the wall. Participants will cross their arms and keep feet flat on the floor. With their back straight, stand up and sit down as many times as possible in 30 seconds.

  4. Isokinetic power

    Time frame: Baseline (week 0) and post-intervention (week 10)

    Upper- and lower-extremity muscle power (Watts/kg) will be measured using an isokinetic dynamometer, bilaterally, at 3 different velocities (30º, 60º, 120º per second).

  5. Isokinetic torque

    Time frame: Baseline (week 0) and post-intervention (week 10)

    Upper- and lower-extremity muscle torque (Nm) will be measured using an isokinetic dynamometer, bilaterally, at 3 different velocities (30º, 60º, 120º per second).

  6. Isometric strength

    Time frame: Baseline (week 0) and post-intervention (week 10)

    Maximal isometric knee and elbow flexor and extensor strength (kg) and grip strength (kg) will also be measured, using a handheld dynamometer.

  7. Global physical activity questionnaire

    Time frame: Baseline (week 0) and post-intervention (week 10)

    The global physical activity questionnaire (GPAQ) consists of 16 items, which are grouped to capture different domains of physical activities including work, transport and discretionary (i.e., leisure or recreational) activities. The GPAQ score may range from 0 to 80,640 MET-minutes per week, although the maximum value is likely not possible to be attained. Higher values indicate greater physical activity levels.

  8. Stroke-Impact Scale (SIS-3.0)

    Time frame: Baseline (week 0) and post-intervention (week 10)

    Version 3 of the Stroke-Impact Scale (SIS-3.0) will be used to assess stroke-specific health-related quality of life. The SIS-3.0 consists of 59 items that measure 8 different domains of health: strength, hand function, (instrumental) activities of daily living, mobility, communication, emotion, cognition, and participation. Each domain is scored separately and range from 0 to 100. Higher values indicate greater health-related quality of life.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Acronym: POWER-F

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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