Online Physical Activity Program for Multiple Sclerosis

(BIPAMS-Cog Trial)

Overseen By Robert W Motl, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Moderate-high exercise risk, others

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

Compensation: Varies

Number of Visits: 13

Duration: 6 months

280 Participants Needed

Trial Summary

What is the purpose of this trial?

We propose a highly-informed, well-designed randomized controlled trial (RCT) that is critical for providing Class I evidence regarding an Internet-delivered physical activity (PA) intervention as a behavioral approach for managing slowed cognitive processing speed (CPS; the most common and perhaps most burdensome MS-related cognitive impairment) and its second learning and memory, symptomatic, and quality of life (QOL) correlates among fully-ambulatory persons with multiple sclerosis (MS) who present with CPS impairment. Such an approach will involve a single-blind, RCT that examines the effects of a remotely-delivered, Internet-based PA intervention compared with an active control condition for yielding immediate and sustained improvements in CPS, learning and memory, symptomatic, and QOL outcomes among persons with mild MS-related ambulatory impairment who demonstrate impaired CPS. The primary outcome is the raw (unadjusted), oral Symbol Digit Modalities Test (SDMT) score as a neuropsychological measure of CPS, and this will be collected remotely via screen-sharing technology. The secondary outcomes include an objective neuropsychological measure of learning and memory (California Verbal Learning Test-II) collected remotely via screen-sharing technology, self-report measures of fatigue (Fatigue Severity Scale), depressive symptoms and anxiety (Hospital Anxiety and Depression Scale), pain (Short-Form, McGill Pain Questionnaire) and QOL (Multiple Sclerosis Impact Scale-29) that will be captured remotely using Qualtrics. The tertiary outcome is accelerometry as an objective, device-based measure of steps/day that will be delivered and returned via pre-paid, pre-addressed envelopes through the United States Postal Service for generating a minimal clinically important difference value that guides the prescription of free-living PA for managing CPS impairment in clinical practice.

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 rather than medication changes.

What data supports the effectiveness of the treatment Behavioral Intervention for Physical Activity in MS (BIPAMS)?

Research shows that web-based and telephone-administered physical activity programs can help people with multiple sclerosis (MS) increase their physical activity levels, improve self-efficacy (belief in one's ability to succeed), and enhance quality of life. These programs have also been effective in reducing fatigue and depression in individuals with MS. ^{1 2 3 4 5}

Is the online physical activity program for multiple sclerosis safe for humans?

The research articles reviewed do not provide specific safety data for the online physical activity program for multiple sclerosis. However, they suggest that physical activity is generally beneficial for people with MS, and web-based interventions are increasingly used to promote exercise safely. ^{3 4 6 7 8}

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

The WellMS treatment is unique because it is an online program specifically designed to increase physical activity in people with multiple sclerosis, using the Internet to deliver behavior change techniques and promote exercise, which is not a standard approach for this condition. ^{2 4 7 9 10}

Research Team

Robert Motl, Ph.D

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for adults in the U.S. with Multiple Sclerosis who are physically inactive, can walk without help, and have had no MS relapses in the last 30 days. Participants must speak English, have internet access, be willing to answer questionnaires, wear an accelerometer device, and accept random assignment to one of two intervention groups.

Inclusion Criteria

I can walk by myself without help.

I am 18 years old or older.

I am willing to fill out the questionnaires.

Exclusion Criteria

Individuals not meeting above inclusion criteria

You have a moderate to high risk of getting hurt or seriously sick from doing very intense exercise.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-month Internet-delivered physical activity intervention focusing on walking during ambulatory activities of daily living

6 months

7 visits (virtual) in the first 2 months, 4 visits (virtual) in the second 2 months, 2 visits (virtual) in the final 2 months

Follow-up

Participants are monitored for sustained improvements in cognitive processing speed, learning and memory, and quality of life

6 months

Outcome assessments at 6-month and 12-month marks

Treatment Details

Interventions

• Behavioral Intervention for Physical Activity in MS (BIPAMS)
• Wellness for MS (WellMS)

Trial Overview The study tests two online interventions aimed at improving cognitive processing speed (CPS) in people with mild MS-related walking difficulties: a physical activity program called BIPAMS and a wellness education program known as WellMS. The main goal is to see if these programs can also improve memory, reduce symptoms like fatigue and pain, and enhance quality of life.

Participant Groups

Group I: Behavioral Intervention for Physical Activity in MS (BIPAMS) Experimental Treatment 1 Intervention

The current behavioral intervention consists of two primary components; an internet website and oneonone video chats with a behavioral coach.The internet website involves content delivered through interactive video courses.The interactive video courses are based on elements of social cognitive theory.Each course consists of an introduction,the primary content,and a take home message.The interactive courses include embedded,supplementary options such as videos on content and worksheets related to the topic.A pedometer is provided for tracking steps,and these steps will be entered into the website so progress can be monitored.The chats support adherence to the intervention,discussion of website material,supportive accountability,and reporting of adverse events/injuries.The chats are conducted facetoface through an online videoconferencing platform.The chats occur 7 times during the first 2 months,4 times during the second 2 months,and twice during the final 2 months of the intervention.

Group II: Wellness for MS (WellMS) Placebo Group 1 Intervention

Provides an internet website and oneonone video chats that discuss materials about self-managing multiple sclerosis (MS) consequences and health indicators through methods other than physical activity.The materials are transformations of brochures provided by the National MS Society,including Gait or Walking Problems:The Basic Facts;MS and Your Emotions;Pain:The Basic Facts; Solving Cognitive Problems;Taming Stress in MS;Food for Thought:MS and Nutrition;and Vitamins,Minerals,and Herbs:An Introduction.The delivery of the internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition,and will have a comparable time commitment. The control condition will not involve tracking steps and a pedometer with not be provided.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

A 4-day interdisciplinary wellness program for 129 individuals with multiple sclerosis (MS) led to significant improvements in self-efficacy and health-related quality of life (QOL) that were sustained for at least 6 months after the intervention.

The improvements in self-efficacy and QOL were consistent across participants regardless of their level of disability, indicating that the program is beneficial for all individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-efficacy and health status improve after a wellness program in persons with multiple sclerosis. Ng, A., Kennedy, P., Hutchinson, B., et al.[2015]

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 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]

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 study involving 64 individuals with multiple sclerosis showed that telephone counseling combined with home monitoring significantly reduced fatigue and depression compared to self-directed physical activity education.

Participants receiving telephone counseling reported a 33.3% improvement in fatigue and a 53.3% improvement in depression, highlighting the effectiveness and high feasibility of this intervention, as nearly all participants completed their scheduled sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. Turner, AP., Hartoonian, N., Sloan, AP., et al.[2018]

In a study of 234 newly diagnosed multiple sclerosis (MS) patients, significant health behavior issues were identified, including high rates of smoking (19%), obesity (15%), and insufficient physical activity (36%), indicating a need for targeted lifestyle interventions.

The research highlighted that higher disability scores (EDSS) were linked to worse health outcomes, such as increased T2-lesion burden and lower quality of life, suggesting that individualized counseling on health behaviors could improve patient outcomes in early MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of health behaviour and clinical manifestation in early multiple sclerosis in Germany - Baseline characteristics of the POWER@MS1 randomised controlled trial. Krause, N., Derad, C., von Glasenapp, B., et al.[2023]

The ActivityMatters program, a 12-week web-based intervention, was found to be feasible and satisfactory for increasing physical activity among 43 participants with mild to moderate multiple sclerosis, with significant improvements in activity levels (p-value 0.042).

Participants engaged with an average of 9.8 out of 11 modules, indicating good adherence to the program, and all behavior change tools were perceived as helpful, except for the chat group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Activity Matters was great - I now realize: if I move, I'm fitter.": development and process evaluation of a web-based program for persons with multiple sclerosis. Daniel, N., Bruns, I., Casey, B., et al.[2023]

A study involving 272 participants with relapsing-remitting multiple sclerosis (RRMS) found that 79% reported walking as their most common form of physical activity, highlighting its importance for this population.

Other popular activities included gardening (44%), weight training (34%), bicycling (30%), and calisthenics (20%), which can help clinicians design effective physical activity programs tailored for individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Most common types of physical activity self-selected by people with multiple sclerosis. Weikert, M., Dlugonski, D., Balantrapu, S., et al.[2021]

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]

In a study of 269 individuals with relapsing-remitting multiple sclerosis (RRMS) over 30 months, two distinct patterns of moderate-to-vigorous physical activity (MVPA) changes were identified: one group showed decreasing activity levels while another group increased their activity levels.

Males were more likely to maintain higher levels of MVPA, while individuals with higher disability status were less likely to do so, suggesting that physical activity interventions should focus on encouraging men and those with lower disability levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and Predictors of Change in Moderate-to-Vigorous Physical Activity Over Time in Multiple Sclerosis. Klaren, RE., Sasaki, JE., McAuley, E., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Self-efficacy and health status improve after a wellness program in persons with multiple sclerosis. [2015]

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

Randomized controlled trial of a behavioral intervention targeting symptoms and physical activity in multiple sclerosis. [2022]

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

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

4. 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]

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

Improving fatigue and depression in individuals with multiple sclerosis using telephone-administered physical activity counseling. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Association of health behaviour and clinical manifestation in early multiple sclerosis in Germany - Baseline characteristics of the POWER@MS1 randomised controlled trial. [2023]

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

"Activity Matters was great - I now realize: if I move, I'm fitter.": development and process evaluation of a web-based program for persons with multiple sclerosis. [2023]

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

Most common types of physical activity self-selected by people with multiple sclerosis. [2021]

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

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

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

Patterns and Predictors of Change in Moderate-to-Vigorous Physical Activity Over Time in Multiple Sclerosis. [2018]