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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores an online physical activity program to help individuals with multiple sclerosis (MS) manage cognitive processing speed, which refers to how quickly one thinks and processes information. The study compares two groups: one using a physical activity program called Wellness for MS (WellMS) and the other focusing on general MS self-management. It is ideal for those with MS who have not experienced a relapse in the last month, can walk unaided, and are currently not very active. Participants must be comfortable using the internet and willing to follow the study's tasks, such as wearing a step tracker. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance MS management strategies.

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 prior data suggests that this Internet-delivered physical activity intervention is safe for managing cognitive processing speed in multiple sclerosis?

Research has shown that the Behavioral Intervention for Physical Activity in MS (BIPAMS) was tested in earlier studies and is generally well-tolerated. No major reports of serious side effects have been directly linked to the program. Participants have successfully adhered to the program and completed the activities, indicating its safety for people with multiple sclerosis (MS) who wish to increase their activity levels.

The program includes online activities and video chats. Participants use a pedometer to count their steps, aiding in tracking progress. This setup integrates into daily life without causing significant disruptions or health risks. Overall, the available research indicates that BIPAMS is safe, making it a promising option for addressing slowed thinking speed in MS. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative online programs to help people with multiple sclerosis (MS) manage their condition. Unlike traditional treatments that often focus on medications to manage symptoms, these approaches emphasize self-management and behavior change. The Behavioral Intervention for Physical Activity in MS (BIPAMS) uses interactive video courses and personalized coaching to encourage physical activity, with progress tracked via a pedometer. In contrast, the Wellness for MS (WellMS) program provides educational resources and video chats without focusing on physical activity. This trial aims to understand how these different approaches can empower individuals with MS to improve their quality of life through accessible, online support.

What evidence suggests that this online physical activity program is effective for managing cognitive processing speed impairment in multiple sclerosis?

Research has shown that the Behavioral Intervention for Physical Activity in MS (BIPAMS) program, a treatment arm in this trial, can help people with multiple sclerosis (MS) become more active. Studies have found that this online program reduces fatigue and improves overall well-being. Participants in these studies reported increased physical activity, which is linked to better cognitive skills, such as faster processing and improved memory. The program includes video courses and one-on-one chats to keep participants motivated and engaged. Overall, evidence supports that BIPAMS can help manage MS symptoms and enhance quality of life. ^{1 2 3 5 6}

Who Is on the Research Team?

Robert Motl, Ph.D

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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 willing to fill out the questionnaires.

I am willing to wear an activity tracking device.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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]

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 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 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]

Citations

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

Internet-Delivered Lifestyle Physical Activity Intervention for ... Primary results of a Phase-III, randomized controlled trials of the Behavioral Intervention for increasing Physical Activity in Multiple Sclerosis project.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04518657

Internet-Delivered Lifestyle Physical Activity Intervention for ... The proposed study, if successful, will provide Class I evidence regarding the efficacy of a 6-month, Internet-delivered, PA intervention compared with an ...

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

Randomized controlled trial of the behavioral intervention ... This study provides evidence for the effectiveness of a novel, widely scalable approach for physical activity promotion and fatigue management in persons with ...

4. ahs.uic.edu ahs.uic.edu/research/bipams-cognition/

BIPAMS-Cognition | College of Applied Health Sciences The Behavioral Intervention for Physical Activity in Multiple Sclerosis-Cognition (BIPAMS-Cognition) study examines the effectiveness of internet-delivered ...

5. 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.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999314002226

Internet-Delivered Lifestyle Physical Activity Intervention ... To examine the efficacy of a physical activity behavioral intervention for improving outcomes of body composition in persons with multiple sclerosis (MS).