Forced Rate Exercise + Rehab for Stroke

Recruiting in Palo Alto (17 mi)

Overseen by Susan Linder, PT, DPT, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Cleveland Clinic

Disqualifiers: Cardiac arrhythmia, Hypertrophic cardiomyopathy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Traditional rehabilitation approaches are time and personnel intensive and costly, and leave \~75% of stroke survivors with residual disability. We propose a clinical trial to determine effects of forced aerobic exercise (FE; i.e., mechanically supplemented) in facilitating upper and lower extremity motor recovery post-stroke in an outpatient rehabilitation setting, to elucidate neural and biochemical substrates of FE-induced motor recovery, and to evaluate cost effectiveness of a FE-centered intervention compared to traditional stroke rehabilitation. The global effect of FE has the potential to enhance recovery in a growing population of stroke survivors in a cost-effective manner, thus accelerating its clinical acceptance.

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 data supports the effectiveness of the treatment Forced Rate Exercise + Rehab for Stroke?

Research shows that aerobic and task-oriented exercises can improve physical activity and motor function in stroke patients. These exercises help enhance cardiovascular health and mobility, which are crucial for recovery after a stroke. ^{1 2 3 4 5}

Is Forced Rate Exercise safe for stroke patients?

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 an ECG stress test and use a harness for fall protection, as no significant cardiovascular or orthopedic issues were reported during the sessions. ^{6 7 8 9 10}

How is the Forced Rate Exercise treatment different from other stroke treatments?

Forced Rate Exercise is unique because it involves mechanically assisted aerobic exercise, which helps stroke survivors achieve moderate levels of exercise intensity without relying on traditional equipment like ergometers. This approach focuses on impairment-specific movements and can enhance both physical activity and brain reorganization after a stroke. ^{6 11 12 13 14}

Research Team

Susan Linder, PT, DPT, PhD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Forced Rate Exercise (Other)

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.

Participant Groups

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).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Cleveland Clinic Cleveland, OH

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1072

Patients Recruited

1,377,000+

Findings from Research

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

References

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

Task-oriented aerobic exercise in chronic hemiparetic stroke: training protocols and treatment effects. [2016]

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

Efficacy of interventions aimed at improving physical activity in individuals with stroke: a systematic review. [2021]

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

Exercise rehabilitation after stroke. [2018]

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

Effects of augmented exercise therapy time after stroke: a meta-analysis. [2022]

5. Switzerland 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. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Intensifying Functional Task Practice to Meet Aerobic Training Guidelines in Stroke Survivors. [2020]

7. England pubmed.ncbi.nlm.nih.gov

High-intensity interval training in stroke rehabilitation. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of high-intensity exercise on cardiorespiratory fitness in stroke survivors: A systematic review and meta-analysis. [2022]

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

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

10. Canada pubmed.ncbi.nlm.nih.gov

Preliminary safety analysis of high-intensity interval training (HIIT) in persons with chronic stroke. [2020]

11. England 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. [2016]

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

Enhancing physical activity and brain reorganization after stroke. [2023]

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

Benefits of a repetitive facilitative exercise program for the upper paretic extremity after subacute stroke: a randomized controlled trial. [2016]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of exercise capacity after severe stroke using robotics-assisted treadmill exercise: a proof-of-concept study. [2022]