Online Physical Activity Intervention for Multiple Sclerosis

(eHAPA-MS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Chungyi Chiu, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Urbana-Champaign

Disqualifiers: High exercise score, No internet, Wheelchair, Non-English, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing an online program designed to help people with Multiple Sclerosis (MS) become more physically active. The program offers personalized advice and support to help users set and achieve their exercise goals. The study aims to see how effective this approach is and how well participants stick to it.

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 seems focused on physical activity, so you may not need to change your medication routine, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the treatment MSPA eClass for multiple sclerosis?

Research shows that exercise can help people with multiple sclerosis (MS) manage symptoms and improve their quality of life. Online platforms are a popular way for people with MS to access physical activity information, which can help them overcome barriers to exercise. Additionally, studies have shown that tailored exercise programs can lead to improvements in exercise capacity and related outcomes for people with MS. ^{1 2 3 4 5}

Is exercise training safe for people with multiple sclerosis?

Exercise training for people with multiple sclerosis is generally safe. A review found that the risk of relapse (worsening of symptoms) was not increased with exercise, and the risk of other adverse events (unwanted effects) was similar to that in healthy people. ^{1 3 6 7 8}

How is the MSPA eClass treatment different from other treatments for multiple sclerosis?

The MSPA eClass is unique because it is an online program designed to increase physical activity in people with multiple sclerosis, offering a convenient and flexible way to engage in exercise from home. Unlike traditional treatments, it focuses on web-based physiotherapy sessions that can be accessed anytime, making it ideal for those who prefer to exercise independently and have the skills to self-manage. ^{1 3 8 9 10}

Research Team

Chungyi Chiu, PhD

Principal Investigator

University of Illinois Urbana-Champaign

Eligibility Criteria

This trial is for adults over 18 with Multiple Sclerosis who haven't had a relapse in the last 30 days. They should be able to walk (with or without help), not currently active (less than 30 minutes of moderate physical activity on most days), and have safe levels for exercise. Participants need internet access, as they'll complete online surveys and wear an activity tracker.

Inclusion Criteria

Participants have Internet access

I can walk by myself or with help from a device.

Participants are willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in the eHAPA-MS online intervention to promote physical activity

4 weeks

Follow-up

Participants are monitored for effectiveness and adherence after the intervention

4 weeks

Treatment Details

Interventions

• MSPA eClass (Behavioral Intervention)

Trial Overview The study tests an online program called eHAPA-MS designed to encourage physical activity among people with Multiple Sclerosis. It's based on the Health Action Process Approach, which focuses on personal motivation and planning. Participants will either receive this intervention or be placed in a control group by chance.

Participant Groups

Group I: MSPA eClass Experimental Treatment 1 Intervention

Group II: Waiting list Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

Chris Harlan

University of Illinois at Urbana-Champaign

Chief Executive Officer since 2019

MBA from the University of Illinois at Urbana-Champaign

Eric Minor

University of Illinois at Urbana-Champaign

Chief Marketing Officer since 2019

Bachelor’s degree in Electrical Engineering from the University of Illinois and MBA from the University of Chicago

Findings from Research

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]

The study involving 208 adults with multiple sclerosis showed that a telephone-delivered fatigue self-management intervention (FM+) significantly reduced self-reported fatigue and increased physical activity compared to a contact-control group after 14 weeks.

The physical activity-only intervention (PA-only) also improved moderate-to-vigorous exercise and step count compared to the control group, indicating that both interventions can positively impact physical activity levels in individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Telephone-Delivered Physical Activity and Fatigue Self-management Interventions in Adults With Multiple Sclerosis. Plow, M., Finlayson, M., Liu, J., et al.[2020]

The Multiple Sclerosis Tailored Exercise Program (MSTEP) is being tested in a one-year randomized controlled trial with 240 participants to determine if it leads to greater improvements in exercise capacity and related health outcomes compared to general exercise guidelines.

The study aims to address unique barriers to exercise for people with MS, focusing on outcomes like functional ambulation, strength, and quality of life, which are crucial for managing the disease effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. Mayo, NE., Bayley, M., Duquette, P., et al.[2021]

An International Consensus Meeting has recommended a core set of outcome measures for exercise studies in multiple sclerosis (MS), which includes tools like the Modified Fatigue Impact Scale and the 6-Minute Walk Test, to standardize data collection and improve the robustness of future research.

By using these standardized measures, researchers can better assess the effects of exercise on MS, ultimately leading to more effective treatment recommendations and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Core outcome measures for exercise studies in people with multiple sclerosis: recommendations from a multidisciplinary consensus meeting. Paul, L., Coote, S., Crosbie, J., et al.[2019]

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]

Web-based interventions have a short-term positive effect on increasing self-reported physical activity in ambulant individuals with multiple sclerosis, with a standardized mean difference of 0.67 based on meta-analysis of 4 studies.

While there is evidence of increased physical activity from self-reports, the current research lacks long-term data and does not include interventions for individuals with more severe mobility limitations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of and User Experience With Web-Based Interventions in Increasing Physical Activity Levels in People With Multiple Sclerosis: A Systematic Review. Dennett, R., Gunn, H., Freeman, JA.[2019]

A web-based physiotherapy intervention helped most participants with multiple sclerosis increase their physical activity levels, primarily through twice-weekly sessions, highlighting its convenience and flexibility.

Feedback from participants emphasized the importance of having supportive supervision from physiotherapists and the need for open discussions about realistic expectations, especially for those with progressive disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative exploration of the participants' experience of a web-based physiotherapy program for people with multiple sclerosis: Does it impact on the ability to increase and sustain engagement in physical activity? Dennett, R., Coulter, E., Paul, L., et al.[2023]

The MOVE MS program, a once-weekly group exercise initiative based on Social Cognitive Theory, showed potential as a feasible long-term exercise option for individuals with multiple sclerosis, despite the challenges posed by the COVID-19 pandemic.

While there were non-significant improvements in exercise participation and several MS-related symptoms among the 17 participants who completed the 7-month program, the study highlights the importance of addressing barriers to sustained exercise in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of the MOVE MS Program: A Feasibility Study on Group Exercise for Individuals with Multiple Sclerosis. Adamson, B., Wyatt, N., Key, L., et al.[2023]

References

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

Evaluating the theoretical content of online physical activity information for people with multiple sclerosis. [2020]

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

Randomized Controlled Trial of a Telephone-Delivered Physical Activity and Fatigue Self-management Interventions in Adults With Multiple Sclerosis. [2020]

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

The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. [2021]

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

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

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

Core outcome measures for exercise studies in people with multiple sclerosis: recommendations from a multidisciplinary consensus meeting. [2019]

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

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

The safety of exercise training in multiple sclerosis: a systematic review. [2022]

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

Effectiveness of and User Experience With Web-Based Interventions in Increasing Physical Activity Levels in People With Multiple Sclerosis: A Systematic Review. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A qualitative exploration of the participants' experience of a web-based physiotherapy program for people with multiple sclerosis: Does it impact on the ability to increase and sustain engagement in physical activity? [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Results of the MOVE MS Program: A Feasibility Study on Group Exercise for Individuals with Multiple Sclerosis. [2023]