High Intensity Exercise for Neurological Dysfunction

Overseen By Mary E Gannotti, PT, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Hartford

Disqualifiers: Unstable cardiac, Uncontrolled seizures, others

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

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The Hawks in Motion (HIM) High Intensity Exercise program is designed to implement the American Physical Therapy Clinical Practice Guidelines and American College of Sports Medicine recommendations for exercise for people with neurologic disability. Doctor of Physical Therapy (DPT) students administer the HIM High Intensity Exercise Program. A prior study evaluated the feasibility, safety, and efficacy of the HIM High Intensity Exercise Program and found it feasible, safe, and effective for 30 people with neurologic disabilities between the ages of 8-99 years. The investigators would like to evaluate whether participation in the HIM High Intensity Exercise Program affects mobility in everyday life. Physical activity will be measured one week before program implementation and one week after to assess if the participants' mobility in everyday improved.

Do I need to stop my current medications for the trial?

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 High Intensity Exercise Program for neurological dysfunction?

Research shows that high-intensity exercise can improve strength and function in people with neurological injuries, such as stroke or brain injury, by enhancing muscle and nervous system adaptation. Studies also suggest that this type of exercise may help with recovery by reducing inflammation and improving brain function. ^{1 2 3 4 5}

Is high-intensity exercise generally safe for people with neurological conditions?

High-intensity exercise has been studied for safety in people with Parkinson's disease and children with concussions, showing no adverse events in these groups. However, the safety of high-intensity exercise in stroke survivors and people with spinal cord injuries is less clear, with some concerns about potential risks, especially without supervision. ^{6 7 8 9 10}

How does the High Intensity Exercise Program treatment differ from other treatments for neurological dysfunction?

The High Intensity Exercise Program is unique because it focuses on high-intensity physical activity, which can improve strength and promote recovery in the nervous system after neural injuries. Unlike other treatments, it involves structured, intense exercise sessions that may enhance functional capacity and self-management of fatigue in individuals with neurological disorders. ^{1 6 11 12 13}

Eligibility Criteria

This trial is for people with various neurological conditions like brain injury, cerebral palsy, and spinal cord injury. It's open to those who can handle high-intensity exercise. The program aims to improve everyday mobility and physical activity.

Inclusion Criteria

I am between 8 and 99 years old.

Understands verbal instructions

I can get a doctor's approval to participate.

Exclusion Criteria

My oxygen levels frequently change.

I do not have specific goals for movement, fitness, or mobility.

No clearance from primary care physician for exercise

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a high-intensity exercise program administered by Doctor of Physical Therapy students, twice a week for 8 weeks

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for changes in physical activity and mobility in everyday life

1 week

1 visit (in-person)

Treatment Details

Interventions

• High Intensity Exercise Program

Trial Overview Participants will engage in a high intensity exercise program designed according to clinical guidelines for individuals with neurologic disabilities. Physical therapy students lead the sessions, aiming to enhance participants' daily mobility.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

Participants will receive two times a week for 8 weeks one hour of individualized exercise program that is based on clinical practice guidelines for high intensity exercise.

Who Is Running the Clinical Trial?

University of Hartford

Lead Sponsor

Trials

15

Recruited

600+

Findings from Research

High-intensity training shows promising benefits for stroke patients, but there is a lack of clear definitions and measurements of exercise intensity in the existing literature, which complicates the prescription of effective training protocols.

The review of 17 studies indicates that while high-intensity training can improve various outcomes like walking speed and cardiovascular fitness, the specific impacts on neurological and musculoskeletal systems remain unclear, highlighting the need for better assessment tools and outcome measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is Intensity and How Can It Benefit Exercise Intervention in People With Stroke? A Rapid Review. Church, G., Smith, C., Ali, A., et al.[2023]

Exercise interventions can significantly improve outcomes in individuals with traumatic brain injury (TBI) by reducing inflammation and promoting neuroplasticity, which are crucial for recovery.

Tailoring physical exercise programs to the specific type and severity of TBI can enhance their effectiveness, making exercise a valuable non-pharmacologic treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical exercise ameliorates deficits induced by traumatic brain injury. Archer, T., Svensson, K., Alricsson, M.[2012]

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]

The SPARX Trial is a Phase II study involving 126 early-stage Parkinson's disease patients, designed to assess the feasibility and efficacy of high-intensity exercise as a treatment for PD symptoms, comparing it to moderate-intensity exercise and usual care.

The trial aims to determine if either exercise intensity can lead to meaningful clinical improvements in motor scores, while also ensuring participant safety and monitoring dropout rates, which will inform future large-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. Moore, CG., Schenkman, M., Kohrt, WM., et al.[2021]

A systematic review of 38 studies involving exercise in adults with spinal cord injury found no serious adverse events (AEs) associated with cardiovascular exercise, suggesting it is safe when following guidelines.

The only notable AEs were musculoskeletal issues related to functional electrical stimulation (FES) walking, while volitional exercise showed very few AEs, indicating that exercise can be beneficial for individuals with spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. Warms, CA., Backus, D., Rajan, S., et al.[2021]

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]

The Montreal Virtual Exertion (MOVE) protocol is a safe and feasible graded exertion test for both healthy children and those with subacute concussion, as no adverse events were reported during the study.

Increases in heart rate and perceived exertion were similar between the MOVE protocol and the traditional Buffalo Concussion Treadmill Test, suggesting that MOVE can effectively assess exertion levels without the need for expensive equipment or in-person supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. Teel, E., Alarie, C., Swaine, B., et al.[2023]

High-intensity interval training (HIIT) was found to be feasible and well-tolerated by fatigued adults aged 20-40 with acquired brain injury, with 60% of participants completing the 18-session program.

Participants showed significant improvements in their VO2max and reported increased motivation to exercise, indicating that HIIT may effectively help manage fatigue in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing fatigue following acquired brain injury: A feasibility study of high intensity interval training for young adults. Dornonville de la Cour, FL., Bærentzen, MB., Forchhammer, B., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Therapeutic physical exercise in neural injury: friend or foe? [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

What Is Intensity and How Can It Benefit Exercise Intervention in People With Stroke? A Rapid Review. [2023]

3. Denmark pubmed.ncbi.nlm.nih.gov

Physical exercise ameliorates deficits induced by traumatic brain injury. [2012]

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

The Value of High Intensity Locomotor Training Applied to Patients With Acute-Onset Neurologic Injury. [2023]

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

Pilot study of intensive exercise on endurance, advanced mobility and gait speed in adults with chronic severe acquired brain injury. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Study in Parkinson disease of exercise (SPARX): translating high-intensity exercise from animals to humans. [2021]

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

Adverse events in cardiovascular-related training programs in people with spinal cord injury: a systematic review. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

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

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

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

A retrospective evaluation of the Brain and Body Fitness Studio service on functional capacity and quality of life in people with neurological disorders. [2023]

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

High Intensity Physical Exercise before the Brain Ischemia Promotes Increase in Brain Injury. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Reducing fatigue following acquired brain injury: A feasibility study of high intensity interval training for young adults. [2022]