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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a high-intensity exercise program can help individuals with neurological disabilities improve their daily mobility. Participants will follow a personalized exercise routine twice a week for eight weeks, guided by Doctor of Physical Therapy students. The goal is to determine if this exercise approach can ease everyday movement for those with mobility challenges due to conditions like cerebral palsy or multiple sclerosis. Individuals with a physical and neurological disability that limits daily activities might be suitable candidates, especially if they can obtain medical clearance and transportation to the trial site. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance mobility for those with neurological disabilities.

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 prior data suggests that this high intensity exercise program is safe for people with neurologic disabilities?

Research has shown that high-intensity exercise is generally safe for people with neurological disabilities. A previous study of the HIM High Intensity Exercise Program found it practical, safe, and effective for 30 participants. Another study on high-intensity treadmill exercise demonstrated that exercising at 80% to 85% intensity is safe for participants. These findings suggest that the exercise program should be well-tolerated. While high-intensity exercise can improve movement and reduce muscle stiffness, following guidelines is crucial to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-intensity exercise programs for neurological dysfunction because they offer a unique, non-pharmaceutical approach to managing symptoms. Unlike standard treatments that often rely on medication to alleviate symptoms, this exercise regimen is designed to improve physical and cognitive function through targeted, personalized workouts. By focusing on high-intensity exercises twice a week for eight weeks, this program aims to directly enhance neural connectivity and brain plasticity, which could lead to more sustainable improvements in neurological health.

What evidence suggests that the High Intensity Exercise Program is effective for neurological dysfunction?

Research has shown that high-intensity exercise can greatly benefit people with neurological disabilities. In this trial, participants will engage in a high-intensity exercise program. One study found that high-intensity interval training (HIIT) led to significant changes in the body that improved exercise ability. Another study suggested that HIIT might even help repair some brain damage associated with conditions like Parkinson's disease. While improvements in memory and thinking are not guaranteed, some small gains have been observed. Overall, high-intensity exercise appears promising for enhancing physical function in those facing neurological challenges. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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 have a physical and neurological disability that affects my daily activities.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8294064/

Evidence-Based Effects of High-Intensity Interval Training on ... Research has indicated that high-intensity interval training induces numerous physiological adaptations that improve exercise capacity.

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1565118/full

Effects of high-intensity exercise on rehabilitation ... Although cognitive function is a key outcome for stroke survivors, the results suggest that high-intensity exercise does not improve cognitive ...

3. nature.com nature.com/articles/s41598-024-83802-9

The effects of high-intensity interval training on cognitive ... The results showed small improvements in information processing, executive function and memory with HIIT compared with controls. Of particular ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05691842

Effectiveness of a High-intensity Interval Exercise Program ... The benefits of a High-Intensity Interval Exercise Program (HIIT) has been proven not only in healthy older adults, but also in different pathologies, such as ...

5. medicine.yale.edu medicine.yale.edu/news-article/high-intensity-exercise-can-reverse-neurodegeneration-in-parkinsons-disease/

High-intensity Exercise May Reverse Neurodegeneration in ... High-intensity exercise induces brain-protective effects that have the potential to not just slow down, but possibly reverse, the neurodegeneration associated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10442603/

Physical activity intervention for the prevention of ... These exercises can help improve mobility, reduce spasticity, increase muscle strength, and promote overall well‐being.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06945835

Study Details | NCT06945835 | High Intensity Exercise and ... A prior study evaluated the feasibility, safety, and efficacy of the HIM High Intensity Exercise Program and found it feasible, safe, and ...

8. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2664948

Effect of High-Intensity Treadmill Exercise on Motor ... This phase 2 randomized clinical trial of 128 participants established that 80% to 85% and 60% to 65% exercise intensities are safe and feasible.