Exercise for Stroke Recovery

(AMPLIFI Trial)

Overseen By Sarah Bruton, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: CNS medications

Disqualifiers: Epilepsy, Substance abuse, Cardiovascular, others

Compensation: Varies

Number of Visits: 8

Duration: 2-3 weeks

48 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, younger adults cannot be on medications that affect the central nervous system.

What data supports the effectiveness of the treatment Aerobic Exercise for stroke recovery?

Research shows that aerobic exercise can help improve independence and mobility in stroke patients, especially when started early. It may also enhance cardiovascular health, which is important for recovery. ^{1 2 3 4 5}

Is aerobic exercise safe for people recovering from a stroke?

Research shows that aerobic exercise can be safe for people recovering from a stroke, but there are concerns about heart-related risks. It's important to monitor heart activity during exercise, and more precise guidelines are needed to ensure safety. ^{6 7 8 9 10}

How does aerobic exercise differ from other treatments for stroke recovery?

Aerobic exercise is unique in stroke recovery because it not only improves physical fitness and motor function but also has the potential to enhance cognitive performance and quality of life. Unlike some conventional therapies, it can be tailored using the FITT principle (frequency, intensity, time, type) to meet individual needs and is underutilized despite its benefits. ^{11 12 13 14 15}

What is the purpose of this trial?

The AMPLIFI study (Adaptive Modulation of Plasticity through Lactate and Fitness Interventions) investigates how short-term aerobic exercise influences brain plasticity and learning in older adults and stroke survivors. The study compares three groups: one performing aerobic cycling exercise at an intensity that increases lactate levels, one doing low-intensity exercise, and one receiving health education without exercise. All participants will complete motor learning tasks and undergo brain stimulation testing (using transcranial magnetic stimulation, or TMS) to assess how well the brain responds to training. The goal is to understand whether different types of exercise can improve brain function, movement, and memory, and how the body's response to exercise (like lactate levels) might support brain health. This research may help identify low-cost, non-invasive interventions-such as targeted exercise-that improve motor and cognitive outcomes in aging and stroke recovery.

Eligibility Criteria

The AMPLIFI study is for older adults and stroke survivors interested in how exercise affects brain health. Participants should be able to perform physical tasks and attend multiple sessions. Those with certain medical conditions or taking specific medications that affect brain plasticity may not qualify.

Inclusion Criteria

For All Participants: Able to provide informed consent

For All Participants: Right-handed (for TMS consistency)

For All Participants: Clearance for moderate-intensity aerobic exercise

Exclusion Criteria

Contraindications to TMS or exercise testing (e.g., implanted neurostimulators, severe hypertension)

Pregnancy

Participation in another interventional trial within the past 30 days

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline assessments including VO2 max testing, cognitive and motor testing, and blood draws

1 week

1 visit (in-person)

Treatment

Participants complete five sessions of either aerobic exercise or health education, with TMS and motor learning tasks conducted pre- and post-intervention

2-3 weeks

5 visits (in-person)

Follow-up

Participants are monitored for changes in cortical inhibition, motor learning, and executive function

1 week

1 visit (in-person)

Treatment Details

Interventions

• Aerobic Exercise

Trial Overview This trial tests the effects of different intensities of cycling exercises versus health education on brain function, movement, and memory. It involves motor learning tasks and non-invasive brain stimulation testing to measure the impact of exercise on neuroplasticity.

Participant Groups

Group I: Aerobic Exercise at Lactate Threshold Experimental Treatment 1 Intervention

Participants complete a 20-minute aerobic cycling session at individually prescribed intensity to achieve lactate threshold, based on VO2 max and blood lactate data. This condition is designed to induce metabolic stress and engage neuromodulatory pathways related to cortical plasticity. Participants complete TMS and motor learning tasks before and after the intervention.

Group II: Low-Intensity Aerobic Exercise Active Control 1 Intervention

Participants complete a 20-minute cycling session at a light workload, below lactate threshold. This condition controls for movement and engagement without significant metabolic challenge. TMS and motor learning outcomes are assessed pre- and post-intervention.

Group III: Education Control Placebo Group 1 Intervention

Participants engage in a 20-minute health education session instead of exercise. This arm serves as a non-exercise control to isolate the effects of physical exertion on neuroplasticity. All outcome measures are collected similarly to the exercise groups.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

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]

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]

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]

References

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

The effect of early aerobic training on independence six months post stroke. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of cardiovascular exercise early after stroke: systematic review and meta-analysis. [2022]

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

Effect of Aerobic Exercise Interventions on Mobility among Stroke Patients: A Systematic Review. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Exercise capacity and cardiovascular adaptations to aerobic training early after stroke. [2016]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility, safety and efficacy of an early aerobic rehabilitation program for patients after minor ischemic stroke: A pilot randomized controlled trial. [2016]

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

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

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

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

8. England pubmed.ncbi.nlm.nih.gov

Aerobic exercise training in stroke survivors. [2016]

9. 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]

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

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial. [2020]

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

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

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

The Effects of High-Intensity Aerobic Exercise on Cognitive Performance After Stroke: A Pilot Randomised Controlled Trial. [2022]

13. Italy pubmed.ncbi.nlm.nih.gov

Comparison of the effectiveness of anti-gravity treadmill exercises and underwater walking exercises on cardiorespiratory fitness, functional capacity and balance in stroke patients. [2023]

14. Ireland pubmed.ncbi.nlm.nih.gov

The effect of aerobic exercise on stroke rehabilitation. [2020]

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

Barriers and Facilitators to Aerobic Exercise Implementation in Stroke Rehabilitation: A Scoping Review. [2021]