Physical Activity for Multiple Sclerosis

Overseen By Lexi Huynh, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must be taking: Disease-modifying therapy

Disqualifiers: Pregnant, High exercise risk, others

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

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a 16-week program designed to promote physical activity in individuals recently diagnosed with multiple sclerosis (MS). Participants receive remote guidance to increase activity levels, with regular coaching sessions and tools like a Fitbit to track progress. The goal is to determine if this Lifestyle Physical Activity Intervention improves physical activity, reduces fatigue, depression, and anxiety, and enhances overall quality of life. It targets those diagnosed with MS within the last two years, who haven't experienced a relapse in the past month, and who can walk without assistance. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for those with MS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on a disease-modifying therapy, so you may need to continue that specific treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it requires participants to be on a disease-modifying therapy, so you may need to continue that specific treatment.

What prior data suggests that this lifestyle physical activity intervention is safe for people with MS?

Research has shown that the Lifestyle Physical Activity Program for people newly diagnosed with multiple sclerosis (MS) is safe. In past studies, this type of program proved practical and well-received. Participants generally found it safe and acceptable.

The program lasts 16 weeks and is conducted remotely. It includes resources like electronic newsletters and regular one-on-one coaching sessions through Zoom. Participants also use a Fitbit to track their daily activity. These tools aim to increase physical activity, which has been linked to better function and quality of life for people with MS.

Overall, this approach has shown promise without major safety concerns. Participants in similar past studies did not report any serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a fresh approach to managing multiple sclerosis (MS) through lifestyle physical activity, rather than relying solely on medication. Unlike traditional MS treatments that often focus on managing symptoms with drugs like interferons or glatiramer acetate, this intervention emphasizes a remote physical activity program. Key features include personalized coaching and real-time activity tracking through a Fitbit, which may empower participants to integrate more movement into their daily lives. This approach could offer a holistic benefit, potentially improving not just physical health, but also mental well-being and overall quality of life for people with MS.

What evidence suggests that this lifestyle physical activity intervention is effective for multiple sclerosis?

Research shows that physical activity programs can benefit people with multiple sclerosis (MS). Studies have found that these programs increase both self-reported and measured physical activity levels. They also reduce fatigue, depression, and anxiety. Many participants report feeling better overall and experiencing a higher quality of life. In this trial, participants in the physical activity condition will receive a remote-delivered physical activity program for 16 weeks, including access to electronic newsletters and regular one-on-one coaching chats over Zoom. These programs can be easily shared with many people, often through online or remote methods. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were diagnosed with Multiple Sclerosis in the last 2 years, can walk without help, have internet access, and are currently not very active. They should be relapse-free for a month, able to read English, and on disease-modifying therapy.

Inclusion Criteria

Internet and e-mail access, and willingness to complete the testing and questionnaires

I was diagnosed with MS by a neurologist in the last 2 years.

I can walk without needing help from a device like a cane.

Exclusion Criteria

Pregnant

Have elevated risk for undertaking strenuous or maximal exercise based on two or more affirmatives on the Physical Activity Readiness Questionnaire (PAR-Q)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete initial assessments of physical activity, MS symptoms, and physical and cognitive function

1 week

1 visit (virtual)

Treatment

Participants receive a 16-week remotely delivered physical activity intervention with coaching and Fitbit tracking

16 weeks

Weekly virtual coaching sessions

Follow-up Assessment

Participants complete follow-up assessments of physical activity, MS symptoms, and physical and cognitive function

1 week

1 visit (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Physical Activity Intervention

Trial Overview The study tests if a 16-week program of lifestyle physical activity delivered remotely can improve physical activity levels and quality of life (QoL) compared to those who wait before starting the program.

How Is the Trial Designed?

Group I: Waitlist condition Experimental Treatment 1 Intervention

Participants will receive access to a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15-30 minutes) over Zoom with a behavioral coach after the follow-up assessment.

Group II: Physical activity condition Experimental Treatment 1 Intervention

Participants in this arm will receive a remote-delivered physical activity program for 16 weeks that includes access to electronic newsletters and regular one-on-one coaching chats (15 - 30 minutes) over Zoom with a behavioral coach after the baseline assessment. Throughout the 16-week period, The investigators will ask participants to wear a Fitbit (provided) for tracking daily physical activity.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

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]

Individuals with mild multiple sclerosis (MS) were found to be moderately less physically active than matched controls, with significant differences in various measures of physical activity, including accelerometer counts and self-reported questionnaires.

Despite the observed reduction in physical activity, the study suggests that behavioral interventions could effectively increase activity levels in people with MS, potentially leading to improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and multiple sclerosis: new insights regarding inactivity. Sandroff, BM., Dlugonski, D., Weikert, M., et al.[2022]

Supervised exercise training is highly beneficial for individuals with multiple sclerosis (MS), yet 80% of them do not engage in enough moderate-to-vigorous physical activity (MVPA).

The paper advocates for a shift towards promoting lifestyle physical activity through behavioral interventions, which could complement structured exercise training and improve overall health outcomes for people with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle physical activity in persons with multiple sclerosis: the new kid on the MS block. Motl, RW.[2022]

The BIPAMS study is a phase III randomized controlled trial designed to evaluate the effectiveness of an internet-delivered behavioral intervention based on social cognitive theory to increase physical activity in individuals with multiple sclerosis, with a 6-month treatment and follow-up period.

This study implements a comprehensive fidelity-monitoring plan to ensure the consistency and quality of the intervention delivery, making it a pioneering model for future behavioral interventions in multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

eHealth-Based Behavioral Intervention for Increasing Physical Activity in Persons With Multiple Sclerosis: Fidelity Protocol for a Randomized Controlled Trial. Silveira, SL., McCroskey, J., Wingo, BC., et al.[2020]

A 6-month randomized controlled trial involving 82 ambulatory individuals with multiple sclerosis showed that an Internet-delivered behavioral intervention significantly reduced fatigue severity, depression, and anxiety, indicating its efficacy in managing these symptoms.

The intervention also successfully increased self-reported physical activity levels, supporting the idea that promoting lifestyle changes can be beneficial for individuals with multiple sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a behavioral intervention targeting symptoms and physical activity in multiple sclerosis. Pilutti, LA., Dlugonski, D., Sandroff, BM., et al.[2022]

The behavior-change intervention aimed at increasing physical activity and reducing sedentary behavior in people with multiple sclerosis was found to be safe, with no significant difference in adverse events compared to usual care.

The intervention was deemed feasible and acceptable by both participants and therapists, with a high attendance rate of 97% among participants, indicating strong engagement, although some modifications were suggested for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, feasibility, acceptability and effects of a behaviour-change intervention to change physical activity behaviour among people with multiple sclerosis: Results from the iStep-MS randomised controlled trial. Ryan, JM., Fortune, J., Stennett, A., et al.[2021]

A study involving 269 participants with relapsing-remitting multiple sclerosis found that increased lifestyle physical activity is associated with reduced walking impairment over a 6-month period, suggesting a potential benefit of physical activity on mobility.

The analysis showed that a standard deviation increase in physical activity correlated with a significant decrease in walking impairment, highlighting the importance of encouraging physical activity as a strategy to manage mobility issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle physical activity and walking impairment over time in relapsing-remitting multiple sclerosis: results from a panel study. Motl, RW., McAuley, E., Wynn, D., et al.[2016]

A study analyzing 20 websites for physical activity information for people with multiple sclerosis (MS) found that they covered an average of only 8 out of 20 behavior change techniques, indicating a lack of comprehensive resources.

The overall quality and coverage of the information were low, with average scores of 0.64 and 0.62 on a scale of 0 to 2, suggesting that improvements are needed in how these techniques are presented online to better support individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the theoretical content of online physical activity information for people with multiple sclerosis. Shirazipour, CH., Baillie, CP., Galaviz, K., et al.[2020]

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]

A study evaluated 157 webpages about physical activity for people with multiple sclerosis (MS) and found that only 27 met the criteria for quality information, with most pages addressing only 5 out of 18 established physical activity guidelines.

The most frequently covered guidelines included identifying MS-specific symptoms and providing examples of aerobic and strength training, indicating a gap in comprehensive adherence to the recommended physical activity guidelines for individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do internet resources align with exercise training and physical activity guidelines for people with multiple sclerosis? Sadeghi-Bahmani, D., Silveira, SL., Baird, JF., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38242351/

Internet-delivered lifestyle physical activity intervention for ... We propose a randomized controlled trial(RCT) of a Social Cognitive Theory-based(SCT), Internet-delivered behavioral intervention targeting lifestyle physical ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29959105/

Phase-III, randomized controlled trial of the behavioral ... The proposed research will provide evidence for the effectiveness of a novel, widely scalable approach for increasing lifestyle physical activity.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003822

Randomized controlled trial of the behavioral intervention ... There were positive intervention effects on self-reported and device-measured LPA as well as PROs measuring fatigue, depression and anxiety symptoms, walking ...

4. epublications.marquette.edu epublications.marquette.edu/cgi/viewcontent.cgi?article=1221&context=exsci_fac

Primary Results of a Phase-III, Randomized Controlled Trial of ... Background: We undertook a phase-III, randomized controlled trial (RCT) that examined the effectiveness of a behavioral intervention based on social cognitive ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034821006556

A web-based life-style, exercise and activity intervention for ... The Lifestyle, Exercise and Activity Package (LEAP-MS) intervention, is a co-designed web-based physical activity intervention for people with progressive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11162540/

Internet-Delivered Lifestyle Physical Activity Intervention for ... We propose a randomized controlled trial(RCT) of a Social Cognitive Theory-based(SCT), Internet-delivered behavioral intervention targeting lifestyle physical ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06355804

Lifestyle Physical Activity Intervention for Persons Newly ... The overall objective of the current study is to determine the efficacy of a 16-week remotely delivered lifestyle behavioral intervention compared with a ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38262331/

Feasibility of a theory-based physical activity intervention ... The results indicate that this intervention was feasible, safe, acceptable, and promising for promoting lifestyle PA in persons newly diagnosed with MS.

9. ijmsc.org ijmsc.org/view/physical-activity-in-multiple-sclerosis-real-world-data-from-saskatchewan-canada

Physical Activity in Multiple Sclerosis: Real-World Data ... Physical activity in people with multiple sclerosis (MS) has been associated with improved function, 1 participation, 2 and quality of life, 3 ...