Exercise and Rehabilitation for Stroke

Overseen By Ryan E Ross, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological disease, Orthopedic condition, Severe hypertension, Uncontrolled diabetes, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help stroke survivors enhance their physical and mental health. It examines whether combining aerobic exercise (a form of physical activity that increases heart rate) with physical rehabilitation can boost recovery. The trial includes two groups: one focusing on stretching and the other on aerobic exercise, with both groups participating in upper body rehabilitation. It suits individuals who experienced a stroke over six months ago and still face arm movement challenges. Participants should be able to move their shoulder and elbow to a certain degree and pass a basic exercise test.

As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants a chance to contribute to groundbreaking stroke recovery methods.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that aerobic exercise is generally safe for people recovering from a stroke. One study found that a planned exercise program is safe for stroke patients. However, the risk of falls and hospital visits may increase during exercise. Close supervision and proper precautions are essential.

Stretching exercises, like those used in the study, are often recommended for stroke recovery. They help maintain joint mobility and reduce pain. Both aerobic exercise and stretching have research support, but supervision is particularly crucial for aerobic activities. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the trial exploring aerobic exercise and stretching combined with upper extremity rehabilitation for stroke recovery. Unlike traditional treatments that often emphasize medication and passive physical therapy, this approach actively engages patients through aerobic exercise and targeted stretching, which could enhance neuroplasticity and motor recovery. By incorporating 200 repetitions of specific exercises, the treatment aims to improve strength and coordination more effectively. This approach could offer a more dynamic and engaging pathway to recovery, potentially shortening rehabilitation time and improving outcomes for stroke survivors.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

Research has shown that aerobic exercise, one of the treatments in this trial, can significantly aid stroke recovery. Studies have found that it improves physical abilities, mental function, and helps reduce depression. For instance, individuals who regularly engage in aerobic exercise often experience better balance, walking ability, and muscle strength. Additionally, aerobic exercise may enhance the brain's receptiveness to other treatments, boosting rehabilitation effects.

In contrast, another treatment in this trial, stretching alone, has not shown strong results in improving recovery after a stroke. While stretching can be part of a larger physical therapy plan, it generally does not have the same impact as aerobic exercise on recovery and function. ^{3 6 7 8 9}

Who Is on the Research Team?

Ryan E Ross, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 50-90 who had a unilateral stroke at least 6 months ago, can communicate, and have moderate arm movement impairment. They must pass an exercise test and have some ability to move the affected arm. Excluded are those with certain medical conditions like severe heart issues, other neurological diseases, severe cognitive impairments or vision problems that affect reaching.

Inclusion Criteria

I have moderate difficulty moving my arm.

I am between 50 and 90 years old.

I can move at least 3 blocks in a minute with my affected arm.

Exclusion Criteria

I have pain in my weak arm that stops me from reaching out.

I have severe difficulty speaking or understanding speech.

Your UBACC score is less than 15.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weeks of intervention sessions combining aerobic exercise with upper extremity rehabilitation

8 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic exercise
• Lower extremity stretching

Trial Overview

The study tests if combining aerobic exercise (AEx) with physical rehabilitation improves physical and mental functions in stroke survivors. It explores whether AEx before rehab makes the brain more responsive to treatment, potentially enhancing recovery outcomes.

How Is the Trial Designed?

Group I: Stretching (CON) + upper extremity rehabilitation Experimental Treatment 2 Interventions

Subjects will perform 15 minutes of lower extremity stretching. Following lower extremity stretching subjects will receive 200 repetitions of DDP.

Group II: Aerobic exercise (AEx) + upper extremity rehabilitation Experimental Treatment 2 Interventions

Subject will receive a total of 24 intervention sessions. In each session, subjects will perform 15 minutes of AEx followed by 200 repetitions of an upper extremity rehabilitation program.

Aerobic exercise is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function
• Reduction of depression

Approved in European Union as Aerobic Exercise for:

• Cardiovascular rehabilitation
• Improvement of physical function
• Enhancement of cognitive function

Approved in Canada as Aerobic Exercise for:

• Rehabilitation after stroke
• Improvement of physical function
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Aerobic exercise is crucial for improving cardiovascular health and overall quality of life in stroke survivors, yet it is often underutilized in rehabilitation plans.

The review emphasizes the FITT principle (frequency, intensity, time, type) for exercise prescription and highlights the potential benefits of high-intensity interval training in reaching higher target heart rates for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does aerobic exercise and the FITT principle fit into stroke recovery? Billinger, SA., Boyne, P., Coughenour, E., et al.[2018]

A survey of 155 Canadian physical therapists revealed that 88% believe aerobic exercise (AE) should be included in treatment for patients with neurological conditions, highlighting its recognized importance in neurorehabilitation.

Despite 77% of therapists prescribing AE, barriers such as patient concerns about safety and operational challenges like lack of staff and time hinder its implementation, indicating a need for improved screening and training procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of aerobic exercise in adult neurological rehabilitation by physical therapists in Canada. Doyle, L., Mackay-Lyons, M.[2022]

Aerobic exercise significantly improves gait endurance and speed in stroke survivors with lower baseline scores, particularly those with left-brain injuries, after a 12-week program of 30 minutes of exercise twice a week.

Participants showed measurable improvements in both the 6-minute walk test and the 10-meter walk test, indicating that structured aerobic exercise can enhance mobility and recovery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Exercise After Left-Sided Stroke Improves Gait Speed and Endurance: A Prospective Cohort Study. Catapani, LB., Dos Santos, TP., Toffano, GC., et al.[2021]

A survey of 568 physical therapists revealed that while 88% agree on the importance of aerobic exercise (AEX) in stroke rehabilitation, 84% identified barriers that hinder its prescription in clinical settings.

The typical AEX prescription varied from 20 to 30 minutes per session, 3 to 5 days a week for 2 to 8 weeks, with most therapists recommending light to moderate intensity based on patient feedback, highlighting the need for clearer guidelines and strategies to enhance AEX implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic Exercise Prescription in Stroke Rehabilitation: A Web-Based Survey of US Physical Therapists. Boyne, P., Billinger, S., MacKay-Lyons, M., et al.[2018]

In a study of 195 stroke patients undergoing submaximal exercise testing, only 2.1% showed significant ECG abnormalities, suggesting that most patients can safely engage in aerobic exercise early in rehabilitation without constant ECG monitoring.

The study indicates that using symptom monitoring and conservative heart rate limits can help physical therapists prescribe safe exercise intensities for stroke patients, even when ECG testing is not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining Safe Participation in Aerobic Exercise Early After Stroke Through a Graded Submaximal Exercise Test. Inness, EL., Aqui, A., Foster, E., et al.[2021]

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]

In a study of 61 hospitalized subacute stroke patients, the amount of aerobic exercise time (AET) during physiotherapy did not significantly differ between ambulatory and non-ambulatory groups, suggesting similar engagement levels in both groups.

However, AET was positively correlated with functional independence in the ambulatory group and cognitive function in the non-ambulatory group, indicating that patient characteristics influence exercise outcomes differently based on ambulation capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlations between aerobic exercise time during physiotherapy and characteristics of patients with subacute stroke: A pilot cross-sectional study. Nozoe, M., Masuya, R., Yamamoto, M., et al.[2023]

A review of 36 studies involving 730 stroke participants and 143 with spinal cord injury found that while exercise has clear benefits for improving physical function, the safety of exercise participation remains uncertain due to a lack of studies specifically designed to track adverse events.

Despite concerns about potential risks, the overall risk-to-benefit ratio favors recommending exercise, especially in supervised settings where participants are screened for safety, although significant contraindications exist for unsupervised exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based risk assessment and recommendations for physical activity clearance: stroke and spinal cord injury. Zehr, EP.[2016]

Aerobic exercise (AEX) significantly improves aerobic capacity in post-stroke patients, with an average increase in peak oxygen consumption (V˙o2peak) of 2.2 mL⋅kg-1⋅min-1 based on a systematic review of multiple studies.

Higher intensity AEX and using a walking mode rather than seated exercises are associated with better improvements in walking speed and endurance, suggesting that exercise should be tailored to the specific tasks patients need to improve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Influencing the Efficacy of Aerobic Exercise for Improving Fitness and Walking Capacity After Stroke: A Meta-Analysis With Meta-Regression. Boyne, P., Welge, J., Kissela, B., et al.[2018]

A scoping review of 13 studies involving 452 participants found that submaximal aerobic exercise testing protocols for individuals post-stroke can be safely implemented without serious adverse events, addressing concerns about cardiovascular risks.

The most common comorbidities among participants included hypertension (41%), diabetes (31%), and dyslipidemia (27%), indicating that these factors should be considered when designing exercise protocols for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. Legasto-Mulvale, JM., Inness, EL., Thompson, AN., et al.[2023]

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