What side effects are associated with this type of intervention?

Intense exercise and the use of a shaky treadmill are being studied to improve walking speed, endurance, and balance in people with Multiple Sclerosis (MS). Common side effects of intense exercise in MS patients can include muscle soreness, fatigue, and the potential for increased spasticity or overheating. However, these interventions are generally well-tolerated and can lead to significant improvements in mobility and quality of life. It is important for patients to work closely with their healthcare providers to tailor exercise programs to their individual capabilities and limitations.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Sclerosis (MS) primarily include disease-modifying therapies such as interferon beta-1a and beta-1b, which have been shown to reduce relapse rates and slow disease progression. While these treatments do not directly mimic the effects of intense exercise or shaky treadmill training, they aim to manage symptoms and improve overall function. Complementary therapies like physiotherapy, which can enhance mobility and balance, are often recommended alongside pharmacologic treatments to improve walking speed, endurance, and balance in MS patients.

What other types of research exist?

Promising novel alternatives for MS patients include: 1) Exergame training, which has shown significant improvements in balance and gait measures, particularly in dual-task conditions. 2) High-intensity interval training (HIIT), which can be adapted to individual fitness levels and has been shown to improve cardiovascular health and endurance. 3) Portable technology for real-time biofeedback and cognitive monitoring, which can help manage symptoms and improve overall function. These alternatives offer innovative approaches to enhance mobility and balance in MS patients.

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High-Intensity Treadmill Training for Multiple Sclerosis

N/A

Recruiting

Led By Brian D Schmit, PhD

Research Sponsored by Marquette University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before training, 1-2 weeks after all training sessions, 6 months after all training sessions

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include muscle soreness or fatigue due to high-intensity exercise. The shaky treadmill might cause dizziness or increase the risk of falls during training sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before training, 1-2 weeks after all training sessions, 6 months after all training sessions

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before training, 1-2 weeks after all training sessions, 6 months after all training sessions

This trial's timeline: 3 weeks for screening, Varies for treatment, and before training, 1-2 weeks after all training sessions, 6 months after all training sessions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in 6-minute walk test

Changes in Daily stepping activity

Changes in Functional Gait Assessment (FGA)

+1 more

Secondary study objectives

Changes in Activities-specific Balance Confidence (ABC) score

Changes in Average Duration of Stepping Bouts

Changes in Berg Balance Scale

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Moderate-Intensity With PerturbationsExperimental Treatment2 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 PertubationsExperimental Treatment2 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 PerturbationsExperimental Treatment1 Intervention

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

Group IV: Moderate-Intensity No PerturbationsActive Control1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) that target the immune system to reduce inflammation and slow disease progression, and symptomatic treatments like physical therapy and exercise. Intense exercise improves walking speed and endurance by enhancing cardiovascular fitness and muscle strength, while the shaky treadmill enhances balance by challenging the body's stability and proprioception. These mechanisms are crucial for MS patients as they help mitigate mobility issues, reduce the risk of falls, and improve overall quality of life.

Find a Location

Who is running the clinical trial?

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

2,014 Previous Clinical Trials

2,696,684 Total Patients Enrolled

18 Trials studying Multiple Sclerosis

1,658 Patients Enrolled for Multiple Sclerosis

Indiana UniversityOTHER

1,019 Previous Clinical Trials

1,114,065 Total Patients Enrolled

1 Trials studying Multiple Sclerosis

15 Patients Enrolled for Multiple Sclerosis

Medical College of WisconsinOTHER

620 Previous Clinical Trials

1,172,424 Total Patients Enrolled

Media Library

High-Intensity Treadmill Training Clinical Trial Eligibility Overview. Trial Name: NCT05735691 — N/A

Multiple Sclerosis Research Study Groups: Moderate-Intensity With Perturbations, Moderate-Intensity No Perturbations, High-Intensity No Perturbations, High-Intensity With Pertubations

Multiple Sclerosis Clinical Trial 2023: High-Intensity Treadmill Training Highlights & Side Effects. Trial Name: NCT05735691 — N/A

High-Intensity Treadmill Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05735691 — N/A

~93 spots leftby Jun 2027

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