Power Exercise for Stroke

(POWER-P Trial)

Recruiting at 1 trial location

Overseen By Ada Tang, PT PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McMaster University

Disqualifiers: Cardiovascular disease, Stroke rehab, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 32

60 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Power Exercise for Stroke Recovery (POWER)?

Research shows that exercise therapy, including strength and aerobic exercises, can improve arm function, motor skills, and overall fitness in stroke patients. These exercises help with recovery by enhancing muscle strength, balance, and endurance without worsening muscle tightness. ^{1 2 3 4 5}

Is Power Exercise for Stroke generally safe for humans?

Research suggests that exercise programs, including Power Exercise for Stroke, are generally safe for stroke recovery when proper guidelines and precautions are followed. Studies have not reported significant safety concerns, but it's important to consider individual health conditions and follow recommended safety measures during exercise. ^{6 7 8 9 10}

How does the POWER treatment for stroke recovery differ from other treatments?

The POWER treatment is unique because it focuses on high-intensity, dynamic resistance training to improve muscle power and movement speed, which are crucial for balance and mobility after a stroke. This approach is different from traditional stroke rehabilitation that often emphasizes muscle strength without considering the speed of movement. ^{9 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

The POWER Pilot Trial is for individuals who are at least 6 months post-stroke. It's designed to help those struggling with muscle weakness, a common issue after stroke that affects daily activities like walking and balance.

Inclusion Criteria

Without significant cognitive impairment that would preclude safe exercise, screened via Montreal Cognitive Assessment-Blind score <18

My stroke has left me with slight to moderate disability.

It has been over 6 months since my stroke.

Exclusion Criteria

I don't have heart conditions that make exercise unsafe.

I am currently participating in or have plans for stroke rehabilitation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Familiarization

Participants build familiarity with the upper and lower body exercises

1 week

3 visits (in-person)

Strength Training

Participants engage in strength training with 2-3 sets of 5-8 repetitions

4 weeks

12 visits (in-person)

Power Training

Participants perform power training with 2-3 sets of 15-20 repetitions at a fast tempo

5 weeks

15 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

Treatment Details

Interventions

• Power Exercise for Stroke Recovery (POWER)

Trial Overview This trial tests a power training program (POWER) against standard lower-intensity strength training recommended for stroke recovery. Participants will be randomly assigned to one of the two groups to compare effectiveness in improving walking, strength, and balance.

Participant Groups

Group I: Power Exercise for Stroke Recovery (POWER) Experimental Treatment 1 Intervention

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).

Group II: Strength Training Engaging Guidelines to Enhance Total Health (STRENGTH) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

McMaster University

Lead Sponsor

Trials

936

Recruited

2,630,000+

Findings from Research

Progressive strength and low-intensity aerobic exercise programs lasting 3 to 6 months can significantly improve motor function, strength, balance, and overall fitness in stroke survivors without worsening spasticity.

Increasing access to community-based physical activity programs is crucial for preventing deconditioning and enhancing the quality of life for individuals recovering from a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. Engardt, M., Grimby, G.[2017]

The DOSE trial demonstrated that higher therapeutic intensity in physical therapy can significantly improve long-term walking outcomes after stroke, with participants achieving over double the steps and aerobic minutes compared to usual care.

A model developed from data of 25 individuals in inpatient rehabilitation provides specific targets for prescribing exercise based on walking impairment, predicting increases of 73 steps and 0.56 minutes of aerobic activity per session, which can help tailor rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. Peters, S., Klassen, T., Schneeberg, A., et al.[2022]

In a study of 200 patients with moderate to severe subacute stroke, those who underwent aerobic training experienced a higher rate of serious adverse events compared to those in the relaxation control group, with an incident rate ratio of 1.70.

The occurrence of serious adverse events in the aerobic training group was significantly influenced by pre-existing conditions such as diabetes mellitus and atrial fibrillation, indicating that these factors may increase risk and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. Rackoll, T., Nave, AH., Ebinger, M., et al.[2022]

This review provides evidence-based guidelines for safely implementing aerobic exercise in the early phases post-stroke, emphasizing the importance of pre-participation screening and monitoring for potential complications like blood pressure dysregulation and cerebral hypoperfusion.

Countermeasures such as avoiding prolonged standing and incorporating lower limb movements are recommended to prevent blood pooling and minimize risks during exercise, ensuring a safer rehabilitation process for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Training and Mobilization Early Post-stroke: Cautions and Considerations. Marzolini, S., Robertson, AD., Oh, P., et al.[2020]

Stroke is a major cause of disability, and currently, only 5-10% of stroke patients receive hyperacute revascularization procedures, highlighting the need for timely interventions.

Early prescribed exercise after a stroke can have significant long-term benefits, but there is a lack of guidelines for clinicians on how to safely implement these activities, necessitating a better understanding of the evidence and physiological principles involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological Treatments for Hospitalized Patients with Stroke: A Nuanced Approach to Prescribing Early Activity. Bahouth, MN., Deluzio, S., Pruski, A., et al.[2023]

Progressive resistance training (PRT) is considered safe for individuals within the first 3 months after a stroke, as no significant increase in adverse events was reported in the studies reviewed.

However, the evidence suggests that PRT does not significantly improve muscle strength, upper limb function, or mobility during this early recovery period, indicating it may not be beneficial for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In the first 3 months after stroke is progressive resistance training safe and does it improve activity? A systematic review. Salter, K., Musovic, A., F Taylor, N.[2019]

High-intensity functional electric stimulation (FES)-assisted exercise therapy (FES-ET) significantly improved motor function in stroke survivors, as measured by the Wolf Motor Function Test (WMFT), compared to low-intensity FES-ET, with a notable effect size of 0.95.

Despite the improvements in objective measures of motor function, self-assessments of motor activity (Motor Activity Log) and overall function (Fugl-Meyer Assessment) did not show significant differences, raising questions about the clinical relevance of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. Kowalczewski, J., Gritsenko, V., Ashworth, N., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Exercise therapy for arm function in stroke patients: a systematic review of randomized controlled trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The Impact of Physical Activity Before and After Stroke on Stroke Risk and Recovery: a Narrative Review. [2020]

3. Sweden pubmed.ncbi.nlm.nih.gov

[Adapted exercise important after stroke. Acute and long-term effects of different training programs]. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Family-mediated exercise intervention (FAME): evaluation of a novel form of exercise delivery after stroke. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Step Number and Aerobic Minute Exercise Prescription and Progression in Stroke: A Roadmap. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Aerobic Training and Mobilization Early Post-stroke: Cautions and Considerations. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Nonpharmacological Treatments for Hospitalized Patients with Stroke: A Nuanced Approach to Prescribing Early Activity. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The Effects of POWER Training in Young and Older Adults after Stroke. [2020]

10. England pubmed.ncbi.nlm.nih.gov

In the first 3 months after stroke is progressive resistance training safe and does it improve activity? A systematic review. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Concurrent neuromechanical and functional gains following upper-extremity power training post-stroke. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Weakness and strength training in persons with poststroke hemiplegia: rationale, method, and efficacy. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. [2016]

14. United States pubmed.ncbi.nlm.nih.gov

Effects of fast functional exercise on muscle activity after stroke. [2016]