Forced Rate Exercise + Rehab for Stroke

Overseen By Donayja Harris, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Cardiac arrhythmia, Hypertrophic cardiomyopathy, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to aid stroke recovery by combining forced aerobic exercise (also known as Forced Rate Exercise) with traditional rehabilitation. The researchers aim to determine if this approach can enhance movement in arms and legs and prove more cost-effective than standard rehabilitation methods. Participants should be 3 to 9 months post-stroke, able to walk 20 meters with assistance, and still experiencing some muscle weakness. As an unphased trial, this study provides a unique opportunity to contribute to innovative stroke recovery research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are actively undergoing physical or occupational therapy, you cannot participate.

What prior data suggests that this forced rate exercise is safe for stroke rehabilitation?

Research has shown that high-intensity aerobic exercise can be a safe and practical option for people recovering from a stroke. It may improve movement and other functions while increasing fitness levels. Early findings suggest that this exercise is safe for stroke patients who have been properly screened beforehand. Studies have not reported any major negative effects, and overall, participants handle the exercise well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the forced rate exercise plus rehabilitation for stroke recovery because it aims to enhance the effectiveness of traditional rehabilitation. Unlike standard rehab, which focuses solely on motor learning and muscle training, this approach integrates forced rate exercise on a cycle, pushing the pedaling rate beyond 75 revolutions per minute. This method potentially accelerates cardiovascular engagement and neuromuscular adaptation by maintaining a target heart rate zone. By combining this with targeted motor training, the treatment offers a more comprehensive approach that could improve both upper and lower extremity functions more efficiently than standard therapies alone.

What evidence suggests that forced rate exercise might be an effective treatment for stroke recovery?

Studies have shown that using a machine to help stroke survivors exercise at a faster pace, known as forced exercise, can greatly improve their ability to move. For example, one study found that participants who engaged in this type of exercise improved their movement skills by 20 points on a standard recovery test. This trial will compare two groups: one receiving Forced Rate Exercise combined with rehabilitation, and another receiving rehabilitation alone. The forced exercise method aids recovery in both arms and legs, and research also shows it can boost mood. These findings suggest that forced exercise might be a promising way to help people recover after a stroke. ^{2 3 6 7 8}

Who Is on the Research Team?

Susan Linder, PT, DPT, PhD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for stroke survivors with residual disability who can participate in outpatient rehab. It's not suitable for those unable to perform forced aerobic exercise or have conditions that exclude them from traditional rehabilitation.

Inclusion Criteria

I have weakness on one side of my body.

I had my first stroke 3-9 months ago, confirmed by a brain scan.

Individuals with chronic stroke able to provide informed consent

Exclusion Criteria

I have been diagnosed with severe narrowing of the aortic valve in my heart.

I have been diagnosed with hypertrophic cardiomyopathy.

History of multiple strokes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo forced aerobic exercise (FE) and rehabilitation to facilitate motor recovery post-stroke

12 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Forced Rate Exercise

Trial Overview The study compares the effectiveness of adding forced rate cycling (mechanically assisted exercise) to regular rehab versus standard rehab alone, focusing on motor recovery and cost-effectiveness.

How Is the Trial Designed?

Group I: Forced Rate Exercise + Rehabilitation Active Control 1 Intervention

The forced rate exercise+rehab group (N=33) will complete FE on the cycle designed to augment pedaling rate to \>75 revolutions per minute (RPM). Target heart rate zone will be set to 60-80% of heart rate (HR) reserve. The session will consist of a 5-min warm-up, 35-min main exercise set, and 5-min cool down. Following FE, abbreviated sessions of motor learning-based training will be administered by a neurologic OT and PT experienced in stroke rehabilitation, with 30 min focused on restoration of UE function (OT) and 15 min focused on LE motor function/ gait training (PT).

Group II: Rehabilitation Active Control 1 Intervention

The rehab group will receive consecutive, full-length sessions of motor learning-based training, administered by a neurologic OT and PT experienced in stroke rehabilitation, with 45 min focused on restoration of UE function (OT) and 45 min focused on LE motor function/ gait training (PT).

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

Eighteen randomized controlled trials were reviewed, revealing that interventions like aerobic and resistance training, electrical stimulation during walking, and robot-assisted arm therapy significantly increased physical activity in stroke patients.

Despite some effective interventions, the overall quality of evidence was low, and many studies showed no significant differences in physical activity, highlighting the need for more robust research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. Aguiar, LT., Nadeau, S., Martins, JC., et al.[2021]

Exercise, particularly aerobic conditioning, is emerging as a crucial therapeutic approach to improve function and cardiovascular health in stroke survivors, addressing both neurological deficits and physical deconditioning.

While there is promising evidence for the benefits of exercise post-stroke, key questions remain about the optimal intensity and prescription of exercise to maximize its effectiveness and prevent future strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise rehabilitation after stroke. Ivey, FM., Hafer-Macko, CE., Macko, RF.[2018]

Transcranial direct current stimulation (tDCS) applied to the motor cortex significantly improved force steadiness during knee exercises in post-stroke patients, indicating its potential to enhance motor performance in rehabilitation.

However, tDCS did not lead to any significant changes in peak muscular torque (PT) for either post-stroke patients or healthy controls, suggesting that while it may aid in stability, it does not increase maximum strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bihemispheric Motor Cortex Transcranial Direct Current Stimulation Improves Force Steadiness in Post-Stroke Hemiparetic Patients: A Randomized Crossover Controlled Trial. Montenegro, RA., Midgley, A., Massaferri, R., et al.[2020]

To optimize recovery after a stroke, rehabilitation methods must be reorganized to include increased frequency and intensity of physical activities, such as strength training and aerobic exercise, to help patients regain energy and participate actively in daily life.

Patients often leave inpatient rehabilitation severely deconditioned, so it's crucial for healthcare providers to promote community-based exercise opportunities and utilize advanced training aids during rehabilitation to enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing physical activity and brain reorganization after stroke. Carr, JH., Shepherd, RB.[2023]

Feedback-controlled robotics-assisted treadmill exercise (RATE) is a feasible method for assessing and guiding cardiovascular exercise in severely impaired individuals early after a stroke, as demonstrated in a study with three subjects.

The study showed that post-stroke individuals have significantly reduced aerobic capacity, but using robotics-assisted devices like the Lokomat can help assess and potentially improve their exercise capacity during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feedback-controlled robotics-assisted treadmill exercise to assess and influence aerobic capacity early after stroke: a proof-of-concept study. Stoller, O., Schindelholz, M., Bichsel, L., et al.[2016]

In a randomized controlled trial involving 52 adults with subacute stroke, repetitive facilitative exercise (RFE) showed significantly greater improvements in upper-limb motor function compared to conventional rehabilitation, as measured by the Action Research Arm Test (ARAT) and Fugl-Meyer Arm (FMA) scores.

The study demonstrated that RFE, which involves high repetition and neurofacilitation, may be a more effective rehabilitation approach for enhancing motor function in stroke patients during the critical subacute phase (3 to 13 weeks post-stroke).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of a repetitive facilitative exercise program for the upper paretic extremity after subacute stroke: a randomized controlled trial. Shimodozono, M., Noma, T., Nomoto, Y., et al.[2016]

Robotics-assisted treadmill exercise (RATE) using a body weight support (BWS) control strategy is a feasible and safe method for evaluating cardiovascular performance in individuals with severe motor impairments after a stroke, as shown in a study with three subjects.

Constant load testing (CLT) provided reasonable oxygen uptake values, but incremental exercise testing (IET) did not yield peak performance due to uncoordinated walking patterns, indicating that IET needs further refinement for better assessment of exercise capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of exercise capacity after severe stroke using robotics-assisted treadmill exercise: a proof-of-concept study. Stoller, O., de Bruin, ED., Schindelholz, M., et al.[2022]

Chronic stroke survivors can achieve moderate levels of cardiometabolic stress through a 30-minute intermittent functional training (IFT) program, which significantly increased oxygen uptake and heart rate without the need for traditional exercise equipment.

The study demonstrated that participants maintained workloads that met the criteria for moderate intensity aerobic exercise, indicating that functional task practice can be an effective rehabilitation strategy for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensifying Functional Task Practice to Meet Aerobic Training Guidelines in Stroke Survivors. Kelly, LP., Devasahayam, AJ., Chaves, AR., et al.[2020]

High-intensity interval training (HIT) may be more effective than conventional aerobic exercise for improving aerobic capacity and functional recovery in stroke patients, based on preliminary studies.

The review emphasizes the need for a structured approach to HIT protocols and highlights the importance of assessing safety, as there has been limited research on the safety of HIT specifically for poststroke individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-intensity interval training in stroke rehabilitation. Boyne, P., Dunning, K., Carl, D., et al.[2021]

High-intensity exercise significantly improves cardiorespiratory fitness in stroke survivors, as evidenced by increased peak oxygen uptake (VO2peak) and performance on the 6-minute walk test, based on a meta-analysis of 17 studies involving various exercise protocols.

The study found no significant difference in adverse events between high-intensity exercise and control groups, suggesting that this type of exercise may be a safe intervention for stroke survivors in cardiopulmonary rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors: A systematic review and meta-analysis. Luo, L., Meng, H., Wang, Z., et al.[2022]

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]

Eighteen participants with chronic stroke safely completed three different high-intensity interval training (HIIT) protocols, showing no signs of cardiovascular intolerance or significant arrhythmias during the sessions.

HIIT protocols with shorter rest periods (30s and 60s) resulted in significantly higher heart rates and blood pressure compared to longer rest periods (120s), indicating that HIIT can effectively elevate cardiovascular responses in stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary safety analysis of high-intensity interval training (HIIT) in persons with chronic stroke. Carl, DL., Boyne, P., Rockwell, B., et al.[2020]

A systematic review of 20 studies involving 2686 stroke patients found that augmented exercise therapy time (AETT) has a small but statistically significant positive effect on activities of daily living (ADL), especially when at least 16 additional hours of therapy are provided within the first 6 months after a stroke.

Higher intensity exercise therapy also showed significant improvements in instrumental ADL and walking speed, but no significant effects were observed for dexterity, indicating that the timing and intensity of rehabilitation are crucial for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of augmented exercise therapy time after stroke: a meta-analysis. Kwakkel, G., van Peppen, R., Wagenaar, RC., et al.[2022]

Task-oriented treadmill exercise can significantly improve motor function and cardiovascular fitness in chronic stroke patients, even years after the initial stroke, challenging the belief that recovery plateaus after 6 months.

A 6-month program of this exercise not only enhances mobility and leg strength but also targets neuromuscular adaptations, suggesting a comprehensive approach to rehabilitation that addresses both neurological and cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Task-oriented aerobic exercise in chronic hemiparetic stroke: training protocols and treatment effects. Macko, RF., Ivey, FM., Forrester, LW.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11071159/

The Utilization of Forced-Rate Cycling to Facilitate Motor ... Forced aerobic exercise preceding task practice improves motor recovery post-stroke. Am J Occup Ther. 2017;71(2):7102290020p7102290021–7102290020p7102290029 ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06585943

I-Score: Intensive Stroke Cycling for Optimal Recovery and ... We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity ...

3. research.aota.org research.aota.org/ajot/article/69/4/6904210010p1/6026/Forced-Aerobic-Exercise-Enhances-Motor-Recovery

Forced Aerobic Exercise Enhances Motor Recovery After Stroke RESULTS. From baseline to end of treatment, the FMA score improved by 20 points, perceived level of recovery on the Stroke Impact Scale ...

4. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/new-trial-to-assess-forced-exercise-for-subacute-stroke-recovery

Trial Assesses Forced Exercise for Subacute Stroke Recovery A novel randomized clinical trial to assess effects of forced exercise (FE) on upper extremity (UE) and lower extremity (LE) motor recovery post-stroke.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12324965/

Task Practice With and Without Aerobic Exercise Improves ... Aerobic exercise has also been shown to have global effects in individuals post-stroke, positively affecting motor and mood-related outcomes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11069437/

An 8-week forced-rate aerobic cycling program improves ... An 8-week forced-rate aerobic cycling program improves cardiorespiratory fitness in persons with chronic stroke: a randomized clinical trial

7. withpower.com withpower.com/trial/phase-stroke-9-2024-1d794

Forced Rate Exercise + Rehab for Stroke Preliminary data suggest that high-intensity interval training (a form of Forced Rate Exercise) can be safe for stroke patients who have been prescreened with ...

8. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/aerobic-exercise-exerts-neuroplastic-effects-in-post-stroke-rehabilitation

Aerobic Exercise Exerts Neuroplastic Effects in Post-Stroke ... Mounting evidence shows that a program of aerobic cycling followed by upper extremity task practice leads to greater rehab gains in stroke ...