Power Exercise for Stroke Recovery: The POWER Feasibility Trial

NCT05816811 | Completed

• 1 other identifier: POWER Feasibility
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Resistance training; Power training; Feasibility study; Skeletal muscle

Outcome Measures

Primary Outcomes (6)

• 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.

  Through study completion, over 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.

  Through study completion, over 13 months

• 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.

  Through study completion, over 13 months

• 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.

  Through study completion, over 13 months

• 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).

  Through study completion, over 13 months

• 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.

  Immediately post-intervention (week 10)

Secondary Outcomes (8)

• Timed up and go test

  Baseline (week 0) and post-intervention (week 10)

• Short physical performance battery

  Baseline (week 0) and post-intervention (week 10)

• 30-second chair stand test

  Baseline (week 0) and post-intervention (week 10)

• Isokinetic power

  Baseline (week 0) and post-intervention (week 10)

• Isokinetic torque

  Baseline (week 0) and post-intervention (week 10)

Study Arms (1)

Power Training

EXPERIMENTAL

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.

Other: Power-focused resistance training

Interventions

Power-focused resistance training OTHER

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

Also known as: Power training

Power Training

Eligibility Criteria

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

You may qualify if:

• ≥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)

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
• Significant cognitive impairment that would preclude safe exercise participation (Montreal Cognitive Assessment score \<26)
• Actively engaged in stroke rehabilitation services

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

School of Rehabilitation Science

Hamilton, Ontario, L8S1C7, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-group pilot trial aimed at examining the feasibility of a 10-week power-focused resistance training intervention for people with stroke

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 18, 2023
• Study Start: August 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

CA (1)