Wheelchair Exercise Training for Multiple Sclerosis

Overseen By Stephanie L Silveira, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Texas, Denton, TX

Disqualifiers: Exercise contradictions, others

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

Compensation: Varies

Number of Visits: 1

Duration: 16 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled clinical trial is to examine the feasibility and initial efficacy of undertaking and delivering a novel, stakeholder-informed exercise training program for wheelchair users with multiple sclerosis. The main questions it aims to answer are: * Is the study feasible as measured by participant recruitment (24 participants total), retention (80%), and safety (adverse events)? * Is the study acceptable as measured by participant satisfaction and perceptions using an evaluation survey and semi-structured interviews? * Is there significant change in following the 16-week study in metabolic health outcomes, MS symptoms, and exercise behavior change? Participants will be randomized to complete the 16-week SPIN exercise training program or WellMS attention/contact wellness program. Researchers will compare the SPIN and WellMS groups to determine if there is a significant difference in metabolic health outcomes, MS symptoms, and exercise behavior change.

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 data supports the effectiveness of the SPIN program treatment for people with multiple sclerosis?

Research shows that physical activity can be beneficial for people with multiple sclerosis, even those who use wheelchairs. For example, a study using Nintendo Wii Fit, which involves seated exercises, showed improvements in physical activity, balance, and strength for people with MS. This suggests that similar seated exercise programs like SPIN could also be effective. ^{1 2 3 4 5}

Is wheelchair exercise training safe for people with multiple sclerosis?

Exercise training is considered safe for people with multiple sclerosis, including those who use wheelchairs, as it helps improve symptoms like mobility and fatigue without significant safety concerns. ^{1 6 7 8 9}

How is the SPIN program treatment different from other treatments for multiple sclerosis?

The SPIN program is unique because it is a home-based exercise training specifically designed for wheelchair users with multiple sclerosis, focusing on both resistance and aerobic exercises. Unlike other treatments, it includes personalized coaching and uses fitness trackers to help manage symptoms and improve physical activity in those with severe mobility impairments. ^{1 6 7 10 11}

Research Team

Stephanie L Silveira, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

This trial is for adults over 18 with Multiple Sclerosis who are mostly wheelchair users and not currently active, meaning they don't do regular physical activity more than twice a week. They must have been relapse-free for the last month and will need a doctor's okay if there are health concerns that usually suggest exercise isn't safe.

Inclusion Criteria

I have been diagnosed with multiple sclerosis (MS).

I use a wheelchair more than half of the time.

I have not had a relapse in the last 30 days.

Exclusion Criteria

I passed a health screen for exercise or have doctor's clearance.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants undergo a 16-week exercise training intervention or wellness control program

16 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Seated Physical activity INtervention for persons with MS, 'SPIN' program
• Wellness for MS (WellMS)- Control Condition

Trial Overview The study tests a new exercise program called SPIN against a wellness program named WellMS in people with MS using wheelchairs. It looks at how well these programs work by checking participant numbers, satisfaction, safety, changes in metabolic health, MS symptoms, and whether participants stick to exercising after the 16-week course.

Participant Groups

Group I: Exercise Training Intervention Experimental Treatment 1 Intervention

Group II: Wellness Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of North Texas, Denton, TX

Lead Sponsor

Trials

13

Recruited

7,100+

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Craig Hospital

Collaborator

Trials

45

Recruited

8,400+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Findings from Research

Over a 2.5-year study involving 269 participants with relapsing-remitting multiple sclerosis, significant improvements were observed in both self-reported and objectively measured physical activity, along with self-efficacy and walking impairment.

Changes in physical activity were strongly associated with improvements in self-efficacy, suggesting that enhancing self-confidence may be key to promoting and maintaining physical activity in individuals with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal change in physical activity and its correlates in relapsing-remitting multiple sclerosis. Motl, RW., McAuley, E., Sandroff, BM.[2022]

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]

A systematic review of 40 randomized controlled trials involving 1780 participants found that exercise training does not increase the risk of clinical relapse or adverse events in individuals with multiple sclerosis, suggesting it is a safe intervention.

The analysis showed no significant differences in the rates of relapse, adverse events, or serious adverse events between exercise training and non-exercise groups, supporting the promotion of exercise as a beneficial activity for people with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. Learmonth, YC., P Herring, M., Russell, DI., et al.[2023]

A systematic review of 8 randomized clinical trials involving 919 individuals with multiple sclerosis found no significant differences in step count or moderate to vigorous physical activity levels between those who participated in physical activity interventions and those who did not.

Despite the interventions, the results indicated that physical activity did not lead to measurable improvements in physical activity intensity or step count, suggesting a need for more studies with objective measures to assess the effectiveness of exercise in individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise and physical activity-interventions on step count and intensity level in individuals with multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials. Arntzen, EC., Bidhendi-Yarandi, R., Sivertsen, M., et al.[2023]

A systematic review of 19 studies found that exercise training, particularly adapted modalities like body-weight support treadmill training and electrical stimulation cycling, can lead to significant improvements in mobility, physical fitness, and quality of life for individuals with severe mobility impairment due to multiple sclerosis (MS).

While conventional exercise training showed some benefits, the majority of positive outcomes were associated with adapted exercise approaches, highlighting the need for accessible exercise interventions for people with MS who have high levels of disability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. Edwards, T., Pilutti, LA.[2022]

Exercise training is now widely recommended for managing multiple sclerosis (MS), reflecting over 25 years of research supporting its benefits for individuals with the condition.

The paper highlights eight emerging research areas, such as behavior change interventions and telerehabilitation, that could enhance the effectiveness and implementation of exercise in clinical practice for MS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current perspectives on exercise training in the management of multiple sclerosis. Motl, RW., Sandroff, BM.[2021]

References

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

Perspectives on Physical Activity Among People with Multiple Sclerosis Who Are Wheelchair Users: Informing the Design of Future Interventions. [2020]

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

Preliminary efficacy of the "SitLess with MS" intervention for changing sedentary behaviour, symptoms, and physical performance in multiple sclerosis. [2022]

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

Longitudinal change in physical activity and its correlates in relapsing-remitting multiple sclerosis. [2022]

4. Egypt pubmed.ncbi.nlm.nih.gov

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

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

Potential benefits of nintendo wii fit among people with multiple sclerosis: a longitudinal pilot study. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Formative evaluation of an exercise training program for persons with multiple sclerosis who are wheelchair users. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Developing a community-engaged wheelchair exercise program for persons with MS: community advisory board formation and feedback. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety of exercise training in multiple sclerosis: An updated systematic review and meta-analysis. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The effect of exercise and physical activity-interventions on step count and intensity level in individuals with multiple sclerosis: a systematic review and meta-analysis of randomized controlled trials. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of exercise training in adults with multiple sclerosis with severe mobility disability: A systematic review and future research directions. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Current perspectives on exercise training in the management of multiple sclerosis. [2021]