Clinical trial NCT05816811: Power Exercise for Stroke Recovery: The POWER Feasibility Trial
Official title: Power Exercise for Stroke Recovery: The POWER Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Resistance training
Power training
Feasibility study
Skeletal muscle
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group pilot trial aimed at examining the feasibility of a 10-week power-focused resistance training intervention for people with stroke
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility: Participant recruitment
timeFrame: Through study completion, over 13 months
measure: Feasibility: Sex and gender distribution
timeFrame: Through study completion, over 13 months
measure: Feasibility: Attendance and attrition
timeFrame: Through study completion, over 13 months
measure: Feasibility: Serious and non-serious adverse events
timeFrame: Through study completion, over 13 months
measure: Feasibility: Exercise tolerance
timeFrame: Through study completion, over 13 months
measure: Feasibility: Satisfaction
timeFrame: Immediately post-intervention (week 10)
Secondary outcomes:
measure: Timed up and go test
timeFrame: Baseline (week 0) and post-intervention (week 10)
measure: Short physical performance battery
timeFrame: Baseline (week 0) and post-intervention (week 10)
measure: 30-second chair stand test
timeFrame: Baseline (week 0) and post-intervention (week 10)
measure: Isokinetic power
timeFrame: Baseline (week 0) and post-intervention (week 10)
measure: Isokinetic torque
timeFrame: Baseline (week 0) and post-intervention (week 10)
measure: Isometric strength
timeFrame: Baseline (week 0) and post-intervention (week 10)
measure: Global physical activity questionnaire
timeFrame: Baseline (week 0) and post-intervention (week 10)
measure: Stroke-Impact Scale (SIS-3.0)
timeFrame: Baseline (week 0) and post-intervention (week 10)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: School of Rehabilitation Science
state: Ontario
Study officials:
References: