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Power Exercise for Stroke Recovery: The POWER Feasibility Trial (POWER-F)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Power-focused resistance training
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Resistance training, Power training, Feasibility study, Skeletal muscle

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School of Rehabilitation ScienceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Power Training

Arm Description

The program is intentionally designed with 3 progressive phases: Phase 1 Familiarization (Week 1) will allow participants to begin with a low-intensity version of the training program (body weight resisted or light weights at RPE 2-3 for 8 repetitions) to acclimate participants to the movements. Phase 2 Strength (Weeks 2-5) will progress in loads to achieve volitional fatigue between 5-8 repetitions (RPE 7-9). Phase 3 Power (Weeks 6-10) will use intensities between RPE 4-6 (15-20 repetitions) and execute each exercise at the highest possible velocity to focus on muscle power. The exercises, selected to emphasize functional movements relevant to daily activities.

Outcomes

Primary Outcome Measures

Feasibility: Participant recruitment
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.
Feasibility: Sex and gender distribution
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.
Feasibility: Attendance and attrition
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.
Feasibility: Serious and non-serious adverse events
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.
Feasibility: Exercise tolerance
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).
Feasibility: Satisfaction
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 Outcome Measures

Timed up and go test
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.
Short physical performance battery
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.
30-second chair stand test
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.
Isokinetic power
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).
Isokinetic torque
Upper- and lower-extremity muscle torque (Nm) will be measured using an isokinetic dynamometer, bilaterally, at 3 different velocities (30º, 60º, 120º per second).
Isometric strength
Maximal isometric knee and elbow flexor and extensor strength (kg) and grip strength (kg) will also be measured, using a handheld dynamometer.
Global physical activity questionnaire
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.
Stroke-Impact Scale (SIS-3.0)
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.

Full Information

First Posted
March 20, 2023
Last Updated
October 20, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05816811
Brief Title
Power Exercise for Stroke Recovery: The POWER Feasibility Trial
Acronym
POWER-F
Official Title
Power Exercise for Stroke Recovery: The POWER Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Resistance training, Power training, Feasibility study, Skeletal muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-group pilot trial aimed at examining the feasibility of a 10-week power-focused resistance training intervention for people with stroke
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Power Training
Arm Type
Experimental
Arm Description
The program is intentionally designed with 3 progressive phases: Phase 1 Familiarization (Week 1) will allow participants to begin with a low-intensity version of the training program (body weight resisted or light weights at RPE 2-3 for 8 repetitions) to acclimate participants to the movements. Phase 2 Strength (Weeks 2-5) will progress in loads to achieve volitional fatigue between 5-8 repetitions (RPE 7-9). Phase 3 Power (Weeks 6-10) will use intensities between RPE 4-6 (15-20 repetitions) and execute each exercise at the highest possible velocity to focus on muscle power. The exercises, selected to emphasize functional movements relevant to daily activities.
Intervention Type
Other
Intervention Name(s)
Power-focused resistance training
Other Intervention Name(s)
Power training
Intervention Description
Participants will undergo 10 weeks of power-focused resistance training.
Primary Outcome Measure Information:
Title
Feasibility: Participant recruitment
Description
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.
Time Frame
Through study completion, over 13 months
Title
Feasibility: Sex and gender distribution
Description
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.
Time Frame
Through study completion, over 13 months
Title
Feasibility: Attendance and attrition
Description
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.
Time Frame
Through study completion, over 13 months
Title
Feasibility: Serious and non-serious adverse events
Description
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.
Time Frame
Through study completion, over 13 months
Title
Feasibility: Exercise tolerance
Description
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).
Time Frame
Through study completion, over 13 months
Title
Feasibility: Satisfaction
Description
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.
Time Frame
Immediately post-intervention (week 10)
Secondary Outcome Measure Information:
Title
Timed up and go test
Description
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.
Time Frame
Baseline (week 0) and post-intervention (week 10)
Title
Short physical performance battery
Description
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.
Time Frame
Baseline (week 0) and post-intervention (week 10)
Title
30-second chair stand test
Description
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.
Time Frame
Baseline (week 0) and post-intervention (week 10)
Title
Isokinetic power
Description
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).
Time Frame
Baseline (week 0) and post-intervention (week 10)
Title
Isokinetic torque
Description
Upper- and lower-extremity muscle torque (Nm) will be measured using an isokinetic dynamometer, bilaterally, at 3 different velocities (30º, 60º, 120º per second).
Time Frame
Baseline (week 0) and post-intervention (week 10)
Title
Isometric strength
Description
Maximal isometric knee and elbow flexor and extensor strength (kg) and grip strength (kg) will also be measured, using a handheld dynamometer.
Time Frame
Baseline (week 0) and post-intervention (week 10)
Title
Global physical activity questionnaire
Description
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.
Time Frame
Baseline (week 0) and post-intervention (week 10)
Title
Stroke-Impact Scale (SIS-3.0)
Description
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.
Time Frame
Baseline (week 0) and post-intervention (week 10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ada Tang, PT PhD
Phone
9055259140
Ext
22867
Email
atang@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Kenneth S Noguchi, MSc
Phone
9055259140
Ext
22867
Email
noguchks@mcmaster.ca
Facility Information:
Facility Name
School of Rehabilitation Science
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S1C7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ada Tang, PT PhD
Phone
9055259140
Ext
22867
Email
atang@mcmaster.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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