Exercise Training for Multiple Sclerosis

Overseen By Tobia Zanotto, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Neurological conditions, Cognitive impairment, Psychiatric problems, Cardiovascular conditions, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how exercise can reduce frailty in people with multiple sclerosis (MS). Participants in the exercise group will use a virtual reality treadmill and engage in resistance training to determine if these activities improve their daily lives. This multimodal exercise training targets those with MS who have experienced weight loss, exhaustion, weakness, slowness, or inactivity but have not had a recent relapse. The goal is to determine if this type of exercise can effectively manage frailty in MS. As an unphased trial, this study offers participants a unique opportunity to contribute to pioneering research that could enhance the quality of life for those with MS.

Will I have to stop taking my current medications?

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 exercise-based intervention is safe for people with MS?

Research has shown that exercise programs using various methods are generally safe for people with multiple sclerosis (MS). One study found that walking on a treadmill, with or without virtual reality, reduced frailty in these individuals. Importantly, participants tolerated the exercise well, and no major side effects occurred.

Another study on treadmill training with virtual reality improved balance and mobility for people with MS. This suggests that this exercise method is both effective and safe. In fact, using virtual reality for exercises like walking and balance has proven to be safe and beneficial.

Overall, evidence supports that this type of exercise training is safe for people with MS, making it a promising option for those interested in clinical trials focused on reducing frailty. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this multimodal exercise training for multiple sclerosis because it integrates virtual reality treadmill training with progressive resistance exercises. Unlike traditional physical therapy, which often focuses on one type of exercise, this method combines different modalities to potentially enhance both physical and neurological benefits. The use of virtual reality adds an engaging and immersive element that may improve adherence and motivation among participants, while the structured resistance training component is backed by evidence to improve muscle strength and function. This comprehensive approach aims to address the diverse symptoms of multiple sclerosis more effectively than standard exercise programs alone.

What evidence suggests that this exercise training is effective for reducing frailty in MS?

Research has shown that combining treadmill and resistance exercises benefits people with multiple sclerosis (MS). In this trial, participants in the Multimodal Exercise Group will engage in a program that includes virtual reality treadmill training (VRTT) and progressive resistance training. For instance, one study found that a six-week treadmill program, with or without virtual reality, reduced frailty in people with MS. Another study demonstrated that virtual reality and balance exercises improved balance and mobility. These exercises also enhance walking while performing another task and increase thinking speed. This training addresses both physical and mental challenges related to MS. Overall, early findings suggest that this type of exercise training holds promise for reducing frailty and improving MS symptoms. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for people aged 40-65 with Multiple Sclerosis (MS) who are not currently having MS relapses, can function with some disability (EDSS score ≤ 6.0), speak English, and meet at least three out of five criteria indicating frailty such as weight loss, exhaustion, weakness, slowness in walking, or low physical activity.

Inclusion Criteria

I haven't had an MS flare-up in the last month.

I can walk at least 100 meters without aid or rest.

Subjects must be fluent in spoken and written English

Exclusion Criteria

I do not have severe heart problems like dangerous irregular heartbeats or major blockages in heart arteries.

I am currently experiencing acute pain in my lower back or legs.

I have a significant neurological condition like Parkinson's or epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group undergo 15 minutes of virtual reality treadmill training, 30 minutes of resistance training, and another 15 minutes of treadmill training

6 weeks

Control

Participants in the control group are placed on a waitlist for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Exercise Training

Trial Overview The study is testing whether a multimodal exercise program can reduce signs of frailty in those living with MS compared to a waitlist group. Participants will be randomly assigned to either start the exercise program immediately or placed on a waitlist as part of the control group.

How Is the Trial Designed?

Group I: Multimodal Exercise Group Experimental Treatment 1 Intervention

Participants will complete 15 minutes of virtual reality treadmill training (VRTT), followed by 30 minutes of progressive evidence-based resistance training (RT), followed by other 15 minutes of VRTT.

Group II: Control Group Experimental Treatment 1 Intervention

Participants randomized to the control group will be put on a waitlist (passive control group) for 6 weeks. Upon completion of post-training assessment, participants in the control group will be able to receive the intervention, if they wish so.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420302007

A multi-modal virtual reality treadmill intervention for ... Primary outcome measures include dual-task gait speed and information processing speed, which will be measured prior to training, one-week post-training, and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32858229/

A multi-modal virtual reality treadmill intervention for ... The purpose of this randomized controlled trial is to establish the benefits of a combined cognitive-motor virtual reality training on MS symptoms

3. archives-pmr.org archives-pmr.org/article/S0003-9993(24)01262-0/fulltext

Effects of a 6-Week Treadmill Training With and Without ... This study provides evidence that a 6-week rehabilitation intervention consisting of TT, augmented or not by VR, reduces frailty levels in pwMS.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034042/

Multimodal exercise training to reduce frailty in people with ... Multimodal exercise training to reduce frailty in people with multiple sclerosis: study protocol for a pilot randomized controlled trial

5. link.springer.com link.springer.com/article/10.1007/s00415-022-11469-1

Treadmill training with virtual reality to enhance gait and ... Exercises delivered via virtual reality (VR) and conventional balance exercises improved balance and mobility in pwMS, while VR-based training ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0003999324012620

Effects of a 6-Week Treadmill Training With and Without ... TT with or without virtual reality can reduce frailty levels in pwMS. While both TT and TT+VR had a positive effect on overall frailty, only TT+VR improved ...

7. researchgate.net researchgate.net/publication/284094454_Effects_of_a_virtual_reality_and_treadmill_training_on_gait_of_subjects_with_multiple_sclerosis_A_pilot_study

Effects of a virtual reality and treadmill training on gait ... The use of VR with lifelike scenarios in people with MS has shown to be safe and effective in motor rehabilitation, including gait, balance and ...