High-Intensity Treadmill Training for Multiple Sclerosis

Recruiting at 1 trial location

Overseen By Brian D Schmit, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marquette University

Must not be taking: Corticosteroids, Botulinum toxin

Disqualifiers: Uncontrolled hypertension, Diabetes, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 35

Duration: 10 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether different types of treadmill training can help people with multiple sclerosis (MS) walk faster, improve balance, and take more steps in daily life. Participants will engage in high or moderate-intensity workouts on a treadmill that can be stable or shaky to determine the most effective combination. The study seeks individuals diagnosed with MS who have stable treatment plans and can walk 10 meters at their normal pace, even with a walking aid. As an unphased trial, it offers a unique opportunity to explore innovative exercise methods that could enhance daily mobility for those with MS.

Will I have to stop taking my current medications?

The trial requires that your MS medications remain stable for at least 1 month before joining, and you cannot have taken corticosteroids for at least 1 month or botulinum toxin injections above the knee for at least 3 months prior to enrollment. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What prior data suggests that this treadmill training is safe for people with multiple sclerosis?

A previous study showed that high-intensity treadmill training with balance challenges helped people with multiple sclerosis improve their walking and balance. Most participants handled the training well, and no major safety issues arose.

Another study found that high-intensity treadmill training without balance challenges improved fitness and mobility for people with multiple sclerosis, although it did result in one serious side effect. Despite this, the training is generally considered safe and feasible.

Moderate-intensity treadmill training with balance challenges was also found to be safe and well-tolerated. Participants improved their walking speed and endurance, with no major side effects reported.

In summary, research suggests that both high- and moderate-intensity treadmill training, with or without balance challenges, are generally safe for people with multiple sclerosis. However, individual experiences may vary, so participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treadmill training techniques for multiple sclerosis (MS) because they focus on improving mobility and balance through innovative exercise methods. Unlike standard MS treatments, which often rely on medications to manage symptoms, these methods aim to enhance physical function directly. The high-intensity treadmill training with and without perturbations challenges the body to improve stamina and balance, potentially leading to better real-world mobility for patients. By introducing balance disruptions during training, the perturbation method specifically seeks to enhance stability and adaptability, which could significantly benefit everyday activities for those with MS.

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

This trial will compare different treadmill training regimens for people with multiple sclerosis. Research has shown that high-intensity treadmill training, with or without added balance challenges, can greatly improve walking and balance. In one study, a 4-week intensive program improved walking and movement for 19 out of 26 participants. This type of training also reduces tiredness and improves overall function. Meanwhile, past studies have suggested that moderate-intensity treadmill training with balance challenges enhances movement and lessens tiredness over time. Overall, these exercise programs seem promising in helping people with multiple sclerosis walk faster and maintain better balance. ^{3 6 7 8 9}

Who Is on the Research Team?

Brian D Schmit, PhD

Principal Investigator

Marquette University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with multiple sclerosis (MS) who can walk 10 meters, have stable MS treatments and disease course, no severe medical conditions or recent heart attacks, and are not pregnant. They must be under 135kg in weight, able to follow commands, and commit to the training program.

Inclusion Criteria

I have no neurological diseases, seizures, nerve injuries in my legs, or brain injuries.

I haven't had a heart attack in the last month, my blood pressure is under control, I don't get dizzy standing up, and my diabetes is managed.

I can walk and move my ankles, knees, and hips within a normal range.

Exclusion Criteria

See inclusion criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Initial assessment of walking function, including gait speed, endurance, and balance

1 week

1 visit (in-person)

Treatment

Participants undergo up to 30 sessions of treadmill training over approximately 10 weeks, with varying intensity and balance perturbations

10 weeks

30 visits (in-person)

Mid-Training Assessment

Assessment of walking function after 15 training sessions

1 week

1 visit (in-person)

Post-Training Assessment

Assessment of walking function after completion of all training sessions

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness six months after training

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High-Intensity Treadmill Training
• Standard Treadmill Training
• Treadmill Training with Perturbations

Trial Overview The study tests whether high-intensity gait training on a shaky treadmill improves walking speed, balance, and community mobility in people with MS. Participants will undergo different combinations of intensity levels and stability during treadmill exercises.

How Is the Trial Designed?

Group I: Moderate-Intensity With Perturbations Experimental Treatment 2 Interventions

30 sessions of moderate-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.

Group II: High-Intensity With Pertubations Experimental Treatment 2 Interventions

30 sessions of high-intensity treadmill training will be conducted. Perturbations that disrupt balance will be applied during the training.

Group III: High-Intensity No Perturbations Experimental Treatment 1 Intervention

30 sessions of high-intensity treadmill training will be conducted on a stable treadmill.

Group IV: Moderate-Intensity No Perturbations Active Control 1 Intervention

30 sessions of moderate-intensity treadmill training will be conducted on a stable treadmill.

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A 4-week intensive multimodal treadmill training program significantly improved gait resistance and mobility in 19 out of 26 participants with multiple sclerosis, compared to only 2 out of 12 in the strength training group.

Participants in the treadmill training group showed greater improvements in speed and mobility, while both groups experienced moderate improvements in balance and executive functions, highlighting the effectiveness of treadmill training for those with moderate to severe disability in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive Multimodal Training to Improve Gait Resistance, Mobility, Balance and Cognitive Function in Persons With Multiple Sclerosis: A Pilot Randomized Controlled Trial. Jonsdottir, J., Gervasoni, E., Bowman, T., et al.[2020]

Treadmill training (TT), body-weight-supported treadmill training (BWSTT), and robot-assisted treadmill training (RATT) have been shown to significantly improve walking speed and endurance in individuals with multiple sclerosis, based on a systematic review of 8 studies involving 161 participants.

Despite the positive outcomes, the review highlights a lack of clarity on which specific type of treadmill training is the most effective, indicating a need for more rigorous randomized controlled trials with larger and more homogeneous groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training in multiple sclerosis: can body weight support or robot assistance provide added value? A systematic review. Swinnen, E., Beckwée, D., Pinte, D., et al.[2022]

Treadmill therapy with partial body weight support (BWS) significantly improves gait ability in nonambulatory stroke patients by allowing them to practice complex walking patterns, leading to more symmetrical walking and reduced spasticity.

Clinical studies indicate that treadmill training is as effective as traditional physiotherapy methods for improving gait in both chronic and acute stroke patients, with upcoming multicenter trials expected to further validate its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training with partial body weight support after stroke. Hesse, S., Werner, C., von Frankenberg, S., et al.[2019]

Treadmill training has been shown to significantly improve gait speed and stride length in patients with Parkinson Disease, based on a systematic review of 18 trials, indicating its potential effectiveness in rehabilitation.

The training was found to be safe, with no increase in dropout rates or reported adverse events, suggesting that it is an acceptable therapy for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treadmill training for patients with Parkinson Disease. An abridged version of a Cochrane Review. Mehrholz, J., Kugler, J., Storch, A., et al.[2018]

In a study involving 22 people with Multiple Sclerosis, multiple sessions of split-belt treadmill training significantly improved gait stability and endurance, as shown by enhanced scores in functional gait assessments and increased distance walked in a 2-minute test.

The addition of cerebellar anodal transcranial direct current stimulation (tDCS) did not provide any extra benefits to locomotor outcomes, indicating that the treadmill training alone was effective in improving mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Split-Belt Training but Not Cerebellar Anodal tDCS Improves Stability Control and Reduces Risk of Fall in Patients with Multiple Sclerosis. Nguemeni, C., Hiew, S., Kögler, S., et al.[2022]

Older adults showed improvements in dynamic stability and recovery step length after repeated exposure to both walkway trips and treadmill belt accelerations, indicating that both methods can enhance balance training.

However, adaptations gained from treadmill training did not transfer to actual trips on a walkway, suggesting that treadmill protocols need to be improved to better mimic real-life scenarios for effective balance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perturbation-Based Balance Training Using Repeated Trips on a Walkway vs. Belt Accelerations on a Treadmill: A Cross-Over Randomised Controlled Trial in Community-Dwelling Older Adults. Song, PYH., Sturnieks, DL., Davis, MK., et al.[2021]

In a study involving 54 healthy young adults, it was found that walking on a treadmill led to a 'cautious gait' characterized by slower speeds and shorter step lengths compared to overground walking.

Despite these adjustments for balance, the dynamic gait stability remained comparable between treadmill and overground walking, suggesting that treadmill training can effectively mimic natural walking conditions for stability control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic gait stability of treadmill versus overground walking in young adults. Yang, F., King, GA.[2022]

In a six-week study involving 20 multiple sclerosis patients, robot-assisted body-weight-supported treadmill training significantly improved the torque of both hip and knee joint muscles, enhancing lower limb muscle power.

This training led to better walking ability for patients, allowing them to walk with less effort and reduced reliance on caregivers, suggesting its potential as an effective rehabilitation method for gait dysfunction in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Body-Weight-Supported Treadmill Training in Gait Impairment in Multiple Sclerosis Patients: A Pilot Study. Łyp, M., Stanisławska, I., Witek, B., et al.[2019]

High intensity training (HIT) is safe and well-tolerated by individuals with multiple sclerosis (MS), showing significant improvements in walking speed and endurance based on a review of 13 studies involving 375 participants.

While HIT demonstrates benefits for certain functional outcomes like walking, the variability in training protocols and exercise types means more research is needed to draw definitive conclusions about its overall effectiveness on balance and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High intensity exercise training on functional outcomes in persons with multiple sclerosis: A systematic review. Bae, M., Kasser, SL.[2023]

Training with treadmill perturbations in the anterior-posterior direction significantly improved recovery responses in older adults, indicating that this type of training can enhance dynamic stabilization of the trunk.

Both groups in the study showed improved recovery from perturbations in both anterior-posterior and medio-lateral directions immediately after training and one week later, suggesting that the benefits of the training were retained over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transfer and retention effects of gait training with anterior-posterior perturbations to postural responses after medio-lateral gait perturbations in older adults. Rieger, MM., Papegaaij, S., Pijnappels, M., et al.[2021]

In a study involving 24 participants with multiple sclerosis, moderate-intensity treadmill walking for 20 minutes significantly improved mood disturbance and vigor immediately after exercise, without increasing fatigue.

These positive effects on mood were temporary, as they diminished after 45 minutes, suggesting that while moderate-intensity walking can be beneficial for mood management in MS, the effects may not be long-lasting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity of treadmill walking exercise on acute mood symptoms in persons with multiple sclerosis. Ensari, I., Sandroff, BM., Motl, RW.[2018]

Citations

1. trialx.com trialx.com/clinical-trials/listings/251945/high-intensity-dynamic-stability-gait-training-in-people-with-multiple-sclerosis/

High-Intensity, Dynamic-stability Gait Training in People ... The goal of this clinical trial is to improve walking speed, balance, and walking in the community for people with multiple sclerosis. This ...

2. withpower.com withpower.com/trial/phase-sclerosis-2023-262c5

High-Intensity Treadmill Training for Multiple Sclerosis A 4-week intensive multimodal treadmill training program significantly improved gait resistance and mobility in 19 out of 26 participants with multiple ...

3. 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.

4. smartpatients.com smartpatients.com/trials/NCT05735691

High-Intensity, Dynamic-stability Gait Training in People ... The goal of this clinical trial is to improve walking speed, balance, and walking in the community for people with multiple sclerosis.

5. nationalmssociety.org nationalmssociety.org/how-you-can-help/get-involved/participate-in-research-studies/participate-in-clinical-trials/clinical-trial-gait-training-people-with-ms

Clinical Trial: Gait Training With MS This study is being conducted to understand whether high intensity exercise and disturbances to balance can be used to improve walking and balance.

6. clinicaltrial.be clinicaltrial.be/fr/details/258964?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

High-Intensity, Dynamic-stability Gait Training in People... This phase I/II clinical trial examines the effects of exercise intensity and balance perturbations on treadmill training in people with multiple sclerosis (MS) ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/388959

High-Intensity, Dynamic-stability Gait Training in People With ... The goal of this clinical trial is to improve walking speed, balance, and walking in the community for people with multiple sclerosis.

8. reporter.nih.gov reporter.nih.gov/search/l-SFCiE4SEWfQo_fF1qDqg/project-details/11126653

Project Details We suggest that high-intensity locomotor training with postural perturbations will elicit the largest changes in both locomotor and balance outcomes, and these ...

9. ijmsc.org ijmsc.org/view/high-intensity-gait-training-in-an-individual-with-neuromyelitis-optica-and-research-recommendations-for-individuals-with-multiple-sclerosis

High-Intensity Gait Training in an Individual With ... This case suggests that HIGT in patients with NMO can be safe and effective in improving functional mobility. Due to the similarities between ...