High-Intensity Treadmill Training for Multiple Sclerosis

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Brian D Schmit, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Marquette University

Must not be taking: Corticosteroids, Botulinum toxin

Disqualifiers: Uncontrolled hypertension, Diabetes, Cardiovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial aims to help people with mild to moderate multiple sclerosis walk better by having them exercise intensely and practice balancing on a shaky treadmill. The combination of these activities is expected to improve their walking speed, endurance, and balance.

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 data supports the effectiveness of High-Intensity Treadmill Training for Multiple Sclerosis?

Research shows that intensive treadmill training, including high-intensity sessions, can significantly improve walking ability, balance, and mobility in people with multiple sclerosis. Studies have found that such training helps increase walking speed and endurance, making it a promising treatment for improving gait and overall mobility in MS patients. ^{1 2 3 4 5}

Is high-intensity treadmill training safe for humans?

High-intensity treadmill training has been shown to be safe for people with multiple sclerosis, as well as for older adults in balance training studies. It is generally considered a safe exercise method in these populations. ^{1 6 7 8 9}

How does High-Intensity Treadmill Training differ from other treatments for multiple sclerosis?

High-Intensity Treadmill Training is unique because it combines high-intensity exercise with dynamic-stability gait training and perturbations, which can significantly improve gait resistance, mobility, and balance in people with multiple sclerosis. This approach is more effective than traditional strength training in enhancing these functional outcomes. ^{1 2 7 10 11}

Research Team

Brian D Schmit, PhD

Principal Investigator

Marquette University

Eligibility Criteria

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 am between 18 and 65 years old and weigh less than 135kg.

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.

Exclusion Criteria

See inclusion criteria.

Trial Timeline

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)

Treatment Details

Interventions

• High-Intensity Treadmill Training (Behavioural Intervention)
• Standard Treadmill Training (Behavioural Intervention)
• Treadmill Training with Perturbations (Behavioural Intervention)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Marquette University Milwaukee, WI

Rehabilitation Hospital of Indiana Indianapolis, IN

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Patients Recruited

202,000+

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

Collaborator

Trials

2103

Patients Recruited

2,760,000+

Indiana University

Collaborator

Trials

1063

Patients Recruited

1,182,000+

Medical College of Wisconsin

Collaborator

Trials

645

Patients Recruited

1,180,000+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

References

1. Switzerland 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. [2020]

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

Intensity of treadmill walking exercise on acute mood symptoms in persons with multiple sclerosis. [2018]

3. Egypt pubmed.ncbi.nlm.nih.gov

Treadmill training in multiple sclerosis: can body weight support or robot assistance provide added value? A systematic review. [2022]

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

Treadmill training with partial body weight support after stroke. [2019]

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

Robot-Assisted Body-Weight-Supported Treadmill Training in Gait Impairment in Multiple Sclerosis Patients: A Pilot Study. [2019]

6. England 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. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

8. Switzerland 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Dynamic gait stability of treadmill versus overground walking in young adults. [2022]

10. Italy pubmed.ncbi.nlm.nih.gov

Treadmill training for patients with Parkinson Disease. An abridged version of a Cochrane Review. [2018]

11. Switzerland 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. [2022]