High-Intensity Gait Training for Multiple Sclerosis

Overseen By Brice T Cleland, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Seizure medications

Disqualifiers: Pregnancy, Cardiac arrhythmia, Diabetes, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether high-intensity walking exercises can help people with multiple sclerosis (MS) improve fatigue and walking issues. Participants will use a treadmill for either moderate-intensity continuous walking or high-intensity interval walking. The researchers aim to determine if these exercises can enhance daily life for those with MS. This trial suits adults who have MS, experience walking difficulties, and frequently feel fatigued. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could improve the quality of life for those with MS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that your disease-modifying therapy (DMT) has been stable for the past 6 months. If you are on medication that could increase motor excitability and lower the seizure threshold, you may not be eligible to participate.

What prior data suggests that high-intensity gait training is safe for individuals with multiple sclerosis?

Research has shown that high-intensity exercise is generally safe for people with multiple sclerosis (MS). Several studies have found that high-intensity interval treadmill training can improve fitness for those with MS. Importantly, participants did not experience more relapses or serious side effects compared to those who did not engage in these exercises. One study noted that while high-intensity exercise challenges the heart and lungs, it does not negatively affect walking. This suggests that high-intensity treadmill training is a well-tolerated option for improving walking and reducing fatigue in people with MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high-intensity gait training for multiple sclerosis because it explores how different exercise intensities can improve mobility. Unlike standard therapies like medication or physical therapy, which often focus on managing symptoms, this approach uses treadmill training to directly enhance walking ability. The trial compares moderate-intensity continuous walking with high-intensity interval training, aiming to see if bursts of intense activity can lead to better outcomes. This could potentially offer a new, non-pharmacological option for improving the quality of life in people with MS.

What evidence suggests that this trial's treatments could be effective for multiple sclerosis?

Research has shown that high-intensity interval treadmill training, one of the treatments studied in this trial, can help people with multiple sclerosis (MS) walk better and feel less tired. Studies indicate that this type of exercise boosts fitness levels, especially in those with mild symptoms. High-intensity training has been linked to improvements in walking and balance, common issues for people with MS. Additionally, this exercise method is safe and can enhance overall physical health. These findings suggest that high-intensity treadmill workouts could be a promising way to manage MS symptoms. Meanwhile, the trial will also evaluate moderate-intensity continuous treadmill training as an active comparator. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for people with Multiple Sclerosis who experience fatigue and walking difficulties. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to ensure safety and effectiveness of the treadmill training intervention.

Inclusion Criteria

I am 21 years old or older.

I have been diagnosed with multiple sclerosis.

My treatment for my condition has not changed in the last 6 months.

Exclusion Criteria

Prisoners

Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task

I have been diagnosed with severe osteoporosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either moderate-intensity continuous treadmill training or high-intensity interval treadmill training to improve fatigue and walking in people with MS

6 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for changes in corticomotor excitability, fatigue impact, walking speed, and other outcomes immediately before and after training

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Treadmill Training

Trial Overview The study investigates if high-intensity gait training on a treadmill can reduce fatigue and improve walking in individuals with Multiple Sclerosis. The goal is to see if this type of exercise could enhance their quality of life.

How Is the Trial Designed?

Group I: High-intensity interval treadmill training Experimental Treatment 1 Intervention

Walking with high intensity intervals interspersed.

Group II: Moderate-intensity continuous treadmill training Active Control 1 Intervention

Continuous walking at a moderate intensity

Treadmill Training is already approved in China for the following indications:

Approved in China as Remote Ischemic Conditioning for:

• Acute moderate ischemic stroke

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12332357/

Effects of high-intensity multimodal functional training on ... High-intensity multimodal functional training can reduce fatigue, walking and balance dysfunctions, and cognitive impairments. Methods.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7687792/

Feasibility and initial efficacy of a high-intensity interval ... However, persons with MS who have walking disability (pwMS-wd) are severely deconditioned and may achieve superior benefits by engaging in high-intensity ...

3. msard-journal.com msard-journal.com/article/S2211-0348(23)00252-3/abstract

High intensity exercise training on functional outcomes in ... High intensity training studies, including RCTs and non-RCTs, that targeted functional outcomes in persons with MS were included in the review.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034818301834

Review article High intensity interval training for people ... HIIT appears to be safe and effective in increasing fitness in people with MS and low levels of disability.

5. trialx.com trialx.com/clinical-trials/listings/290222/effects-of-high-intensity-gait-training-on-fatigue-gait-and-neuroplasticity-in-people-with-multiple-sclerosis/

Effects of High-intensity Gait Training on Fatigue ... Current recommendations of 30 min/day 2 days/week of low to moderate exercise training can improve symptomatic fatigue, aerobic capacity, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10637110/

Safety of exercise training in multiple sclerosis - PubMed Central Studies showed no higher risk of relapse, adverse events, or serious adverse events for exercise training than non-exercise in MS patients. Exercise may be ...