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

Trial Summary

What is the purpose of this trial?

Stroke is a leading cause of disability in the U.S. and many Veteran stroke survivors live with severe disability. Despite recent advances in rehabilitation treatments many stroke survivors have persistent physical and mental difficulties such as reduced physical and cognitive function and depression. Developing innovative treatments that address these problems is necessary to improve long-term outcomes for stroke survivors. Aerobic exercise (AEx) can improve physical and cognitive function, and reduce depression. Additionally, AEx may enhance physical rehabilitation by making the brain more receptive to, and consequently improving the response to an intervention. Therefore, combining AEx with physical rehabilitation has the potential to improve multiple aspects of stroke recovery. This study will examine the effect of combining AEx with physical rehabilitation on physical and mental function in stroke survivors. By gaining a better understanding of the effects of this combined intervention the investigators aim to advance the rehabilitative care of Veteran stroke survivors.

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.

What data supports the effectiveness of the treatment Aerobic exercise, Aerobic Exercise, AEx, Physical Activity, Exercise Therapy, Lower extremity stretching, Physical therapy stretching, Rehabilitation stretching for stroke?

Research shows that aerobic exercise can improve walking speed and endurance in people who have had a stroke, which suggests it can help with recovery and rehabilitation. ^{1 2 3 4 5}

Is exercise and rehabilitation safe for stroke patients?

Exercise and rehabilitation, including aerobic exercise, are generally considered safe for stroke patients when conducted in supervised environments. While there are concerns about cardiovascular risks, studies suggest that the benefits of exercise outweigh the risks, especially when participants are screened and monitored. ^{1 2 6 7 8}

How is aerobic exercise treatment unique for stroke rehabilitation?

Aerobic exercise is unique for stroke rehabilitation because it focuses on improving cardiovascular health and functional capacity, which are often compromised after a stroke. Unlike other treatments, it uses the FITT principle (frequency, intensity, time, type) to tailor exercise programs, and recent studies suggest that high-intensity interval training can help achieve higher heart rates, potentially leading to better recovery outcomes. ^{1 2 3 9 10}

Research Team

Ryan E Ross, PhD

Principal Investigator

Ralph H. Johnson VA Medical Center, Charleston, SC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

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

Aerobic Exercise Prescription in Stroke Rehabilitation: A Web-Based Survey of US Physical Therapists. [2018]

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

Adverse Events During Submaximal Aerobic Exercise Testing in People With Subacute Stroke: A Scoping Review. [2023]

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

Utilization of aerobic exercise in adult neurological rehabilitation by physical therapists in Canada. [2022]

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

Aerobic Exercise After Left-Sided Stroke Improves Gait Speed and Endurance: A Prospective Cohort Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Correlations between aerobic exercise time during physiotherapy and characteristics of patients with subacute stroke: A pilot cross-sectional study. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

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

7. 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]

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

Determining Safe Participation in Aerobic Exercise Early After Stroke Through a Graded Submaximal Exercise Test. [2021]

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

Does aerobic exercise and the FITT principle fit into stroke recovery? [2018]

10. United States 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. [2018]