Cycling and Virtual Reality for Multiple Sclerosis

(PACE-MS Trial)

Overseen By Carly Wender, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Must not be taking: Steroids, Benzodiazepines

Disqualifiers: Neurological disorders, Uncontrolled psychiatric, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

To compare the effects of cycling exercise with different types of virtual reality on processing/thinking speed in persons with multiple sclerosis (MS).

Will I have to stop taking my current medications?

The trial requires that you do not use medications that may impact cognition, such as steroids or benzodiazepines. If you are taking these, you may need to stop before participating.

What data supports the effectiveness of the treatment PACE-MS for multiple sclerosis?

Research suggests that both cycling and virtual reality (VR) exercises can improve physical and cognitive abilities in people with multiple sclerosis (MS). VR-based exercises, in particular, have shown to enhance motivation and therapy outcomes, potentially making them more effective than conventional exercises. ^{1 2 3 4 5}

Is cycling and virtual reality safe for people with multiple sclerosis?

In a study where people with multiple sclerosis participated in a physical activity expedition, some experienced minor medical events, but those with mild disability and no other health issues had no problems. This suggests that physical activity, like cycling, can be safe for some people with MS, but individual health conditions should be considered. ^{6 7 8 9 10}

How is the PACE-MS treatment different from other treatments for multiple sclerosis?

The PACE-MS treatment is unique because it combines cycling with virtual reality (VR) to enhance physical and cognitive abilities in people with multiple sclerosis. This approach leverages VR to create an engaging and immersive environment, which has been shown to improve outcomes more effectively than conventional exercise alone. ^{2 4 10 11 12}

Research Team

Carly Wender, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

This trial is for English-speaking individuals with a confirmed MS diagnosis by a neurologist, who have been free of relapses and steroids for at least 30 days, and report moderate mobility disability. It excludes those with other neurological disorders or uncontrolled psychiatric conditions, contraindications to exercise, cognition-impacting medications use (like steroids), current pregnancy, severe cognitive impairment, high motion sickness likelihood or regular cyclists.

Inclusion Criteria

I have been diagnosed with MS by a neurologist.

I haven't had a relapse or taken steroids in the last 30 days.

I have some difficulty moving around on my own.

Exclusion Criteria

Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)

I am taking medication that could affect my thinking or memory.

Currently pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants complete three cycling conditions: cycling alone, cycling with cognitively stimulating VR, and cycling with visually stimulating VR, one per week.

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for processing speed improvements after each cycling session.

1 week

Treatment Details

Interventions

• PACE-MS

Trial Overview The PACE-MS trial aims to compare the effects on processing/thinking speed in people with MS when they participate in cycling exercises combined with different types of virtual reality experiences.

Participant Groups

Group I: Cycling with Visually Stimulating VR Experimental Treatment 1 Intervention

Cycling with virtual reality where I only have to look at the environment while I cycle.

Group II: Cycling with Cognitively Stimulating VR Experimental Treatment 1 Intervention

Cycling with virtual reality where I have to complete a thinking task while cycling in the virtual environment.

Group III: Cycling Alone Active Control 1 Intervention

Cycling alone, with no virtual reality.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Consortium of Multiple Sclerosis Centers

Collaborator

Trials

9

Recruited

50,200+

Findings from Research

A study involving 68 people with multiple sclerosis showed that exergaming (EXE), balance training (BAL), and cycling (CYC) significantly improved clinical and motor symptoms, with EXE being particularly effective in enhancing gait and balance.

Exergaming also led to improvements in quality of life and walking capacity, indicating it may be a superior exercise option for reducing mobility limitations in individuals with multiple sclerosis compared to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Effects on Multiple Sclerosis Quality of Life and Clinical-Motor Symptoms. Tollár, J., Nagy, F., Tóth, BE., et al.[2021]

A systematic review of 10 randomized clinical trials found that both conventional exercise and virtual reality (VR) exergaming positively impact the physical and cognitive abilities of people with multiple sclerosis (PwMS).

VR exergaming was generally more effective than conventional exercise in enhancing physical and cognitive abilities, improving psychosocial status, and reducing fatigue in PwMS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing virtual reality exergaming with conventional exercise in rehabilitation of people with multiple sclerosis: A systematic review. Moeinzadeh, AM., Calder, A., Petersen, C., et al.[2023]

Immersive virtual reality (VR) training using a head-mounted display (HMD) significantly improved walking speed in patients with multiple sclerosis and stroke compared to conventional treadmill training and semi-immersive VR, indicating its potential effectiveness for gait rehabilitation.

Participants reported higher motivation and preference for the HMD-based training, with no adverse effects like simulator sickness, suggesting that immersive VR could enhance therapy outcomes and patient engagement in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality during gait rehabilitation increases walking speed and motivation: a usability evaluation with healthy participants and patients with multiple sclerosis and stroke. Winter, C., Kern, F., Gall, D., et al.[2021]

A novel immersive virtual reality (VR) kitchen application was developed and tested over an 8-week period on people with multiple sclerosis (pwMS) who have upper-limb dysfunction, showing high satisfaction scores (4.0 to 4.6) for enjoyment and effectiveness in rehabilitation.

The system demonstrated low-to-moderate levels of discomfort (scores between 2.8 and 1.3) during use, indicating it is a safe and feasible option for upper-limb training, setting the stage for future randomized controlled trials to assess its benefits compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Immersive Virtual Kitchen Training System for People with Multiple Sclerosis: A Development and Validation Study. Pau, M., Cocco, E., Arippa, F., et al.[2023]

Virtual reality balance training significantly improves postural control in individuals with multiple sclerosis compared to no intervention, based on a meta-analysis of 11 studies involving 466 participants.

However, when compared to conventional training methods, virtual reality did not show a significant advantage, suggesting it may be at least as effective as traditional approaches for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality training for balance and gait rehabilitation in people with multiple sclerosis: a systematic review and meta-analysis. Casuso-Holgado, MJ., Martín-Valero, R., Carazo, AF., et al.[2019]

Training for and participating in a unique expedition led to a significant reduction in motor fatigue among participants with multiple sclerosis, particularly those with mild disability, indicating potential benefits of physical activity in this population.

Despite some minor medical events reported, no major adverse events occurred, suggesting that the expedition was safe for participants with MS, especially those without cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a 5-day expedition to machu picchu on persons with multiple sclerosis. D'hooghe, MB., Feys, P., Deltour, S., et al.[2021]

Individuals with multiple sclerosis (MS) showed significantly lower physical function and walking performance compared to healthy controls, as evidenced by lower peak cadence and fewer purposeful steps during daily activities.

Peak cadence, measured through accelerometry, is strongly associated with walking performance in MS patients, suggesting it could be a valuable metric for assessing real-world walking ability and the impact of disability on mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free-Living Peak Cadence in Multiple Sclerosis: A New Measure of Real-World Walking? Zheng, P., Jeng, B., Huynh, TLT., et al.[2023]

In two randomized controlled trials involving 38 participants with multiple sclerosis, a significant increase in physical activity was observed from baseline to the first week of a behavioral intervention, suggesting a reactivity effect in the initial assessment.

Study 1 showed an increase of 1,822 steps per day (moderate effect size), while Study 2 showed an even larger increase of 2,338 steps per day (large effect size), indicating that participants may have altered their activity levels upon awareness of being monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactivity in baseline accelerometer data from a physical activity behavioral intervention. Motl, RW., McAuley, E., Dlugonski, D.[2018]

Exercise and physical activity have been shown to provide various benefits for individuals with multiple sclerosis (MS), including improvements in immune function, brain health, walking ability, cognitive performance, fatigue, depression, pain, and overall quality of life.

Despite the positive effects, there is significant variability in the outcomes of exercise interventions for MS, highlighting the need for better-designed studies and a focus on challenges in implementing effective exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from clinical trials of exercise and physical activity in people with MS - guidance for improving the quality of future research. Motl, RW., Fernhall, B., McCully, KK., et al.[2022]

The RT3 accelerometer demonstrated moderate to good test-retest reliability for measuring motion in people with multiple sclerosis, particularly showing strong reliability in the stair-climbing task (ICC = 0.76) and the 5-minute walk test (ICC = 0.64).

Inconsistencies in motor-task performance among both participants with MS and nondisabled individuals suggest that measurement errors may occur, indicating the need for improved methods of attaching the RT3 and careful study design in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of RT3 accelerometer for measuring mobility in people with multiple sclerosis: pilot study. Hale, L., Williams, K., Ashton, C., et al.[2022]

A six-week virtual reality-based treadmill training program for eight individuals with relapsing-remitting multiple sclerosis showed significant improvements in gait speed and stride length during dual-task walking, which were maintained one month after the intervention.

The training also enhanced the participants' ability to negotiate obstacles, indicating that this combined approach is both feasible and safe for individuals with moderate disabilities in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a virtual reality and treadmill training on gait of subjects with multiple sclerosis: a pilot study. Peruzzi, A., Cereatti, A., Della Croce, U., et al.[2022]

In a study involving 25 individuals with multiple sclerosis, virtual reality-based treadmill training significantly improved gait parameters, including hip range of motion and hip-generated power, compared to traditional treadmill training.

Both training methods enhanced walking endurance and speed, but the virtual reality group showed additional benefits in balance and greater improvements in specific gait measures, highlighting its potential as an effective rehabilitation tool for gait deficits in multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovative training program based on virtual reality and treadmill: effects on gait of persons with multiple sclerosis. Peruzzi, A., Zarbo, IR., Cereatti, A., et al.[2022]

References

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

Exercise Effects on Multiple Sclerosis Quality of Life and Clinical-Motor Symptoms. [2021]

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

Comparing virtual reality exergaming with conventional exercise in rehabilitation of people with multiple sclerosis: A systematic review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Immersive virtual reality during gait rehabilitation increases walking speed and motivation: a usability evaluation with healthy participants and patients with multiple sclerosis and stroke. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

An Immersive Virtual Kitchen Training System for People with Multiple Sclerosis: A Development and Validation Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Effectiveness of virtual reality training for balance and gait rehabilitation in people with multiple sclerosis: a systematic review and meta-analysis. [2019]

6. Egypt pubmed.ncbi.nlm.nih.gov

Impact of a 5-day expedition to machu picchu on persons with multiple sclerosis. [2021]

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

Free-Living Peak Cadence in Multiple Sclerosis: A New Measure of Real-World Walking? [2023]

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

Reactivity in baseline accelerometer data from a physical activity behavioral intervention. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Lessons learned from clinical trials of exercise and physical activity in people with MS - guidance for improving the quality of future research. [2022]

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

Reliability of RT3 accelerometer for measuring mobility in people with multiple sclerosis: pilot study. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a virtual reality and treadmill training on gait of subjects with multiple sclerosis: a pilot study. [2022]

12. England pubmed.ncbi.nlm.nih.gov

An innovative training program based on virtual reality and treadmill: effects on gait of persons with multiple sclerosis. [2022]