Behavioral Intervention for Multiple Sclerosis

(BIPAMS Trial)

Overseen By Robert W Motl, PhD

Age: 18 - 65

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: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a 6-month online program can help people with multiple sclerosis (MS) become more active, potentially improving their mobility, mental sharpness, symptoms, and overall quality of life. Participants will join either the BIPAMS program, which focuses on staying active with MS, or the WELLMS program, which addresses managing MS in other ways. The trial seeks individuals diagnosed with MS who have been relapse-free for the last 30 days, have internet access, and are not regularly active. Those who can walk without a wheelchair and are willing to use fitness trackers and complete surveys may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for those with MS.

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 increasing physical activity through a behavioral intervention.

What prior data suggests that this behavioral intervention is safe for individuals with MS?

Research has shown that the BIPAMS treatment, a behavioral program for individuals with Multiple Sclerosis (MS), poses low risk. It helps participants stay active through an online program and video chats with a coach. As it is neither a drug nor a medical procedure, participants typically find it easy to manage. The absence of a data safety monitoring board indicates a lack of safety concerns common in higher-risk studies. This suggests that participants generally do not experience negative effects from the program itself. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BIPAMS intervention for Multiple Sclerosis (MS) because it offers a new approach that focuses on empowering patients through behavioral change rather than traditional medication or physical therapy. Unlike standard treatments that often rely on drugs to manage symptoms, BIPAMS uses a dedicated Internet platform and video chats with a behavioral coach to teach skills and strategies for maintaining physical activity with MS. This innovative method is designed to enhance self-management and improve quality of life, offering a personalized and accessible way for individuals to take control of their health.

What evidence suggests that this trial's behavioral interventions could be effective for multiple sclerosis?

Research shows that the BIPAMS program, available to participants in this trial, can help people with multiple sclerosis (MS) become more physically active. Studies have found that online learning increases moderate-to-vigorous exercise in people with MS. This rise in activity links to better brain function, including improvements in learning and memory. The BIPAMS program uses a website and video chats with a coach to teach ways to stay active. These enhancements in activity and brain function can lead to a better quality of life and fewer symptoms for people with MS. Meanwhile, the WELLMS program, another treatment arm in this trial, focuses on self-managing MS consequences and health indicators through methods other than physical activity. ^{1 2 3 4 6}

Who Is on the Research Team?

Donald Lein, PhD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

This trial is for adults aged 18-64 with Multiple Sclerosis who are not currently active, can walk with or without assistance, and have been relapse-free for the last 30 days. Participants must have internet access, be willing to complete questionnaires and wear an accelerometer. Those at moderate/high risk for strenuous exercise or more than one 'yes' on the PAR-Q are excluded.

Inclusion Criteria

Internet and email access

I have been diagnosed with multiple sclerosis (MS).

I am willing to fill out questionnaires, wear a tracking device, and be randomly assigned to a treatment group.

Exclusion Criteria

If you answer "yes" to more than one question on the PAR-Q, you may be at moderate or high risk for strenuous exercise and won't be able to participate in the study. If you answer "yes" to only one question, you may be at low risk and can participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-month behavioral intervention delivered through the Internet, focusing on increasing physical activity and improving mobility, cognition, symptoms, and quality of life.

6 months

Regular virtual sessions with a behavioral coach

Follow-up

Participants are monitored for sustained physical activity behavior and improvements in mobility, cognition, symptoms, and quality of life.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• BIPAMS
• WELLMS

Trial Overview The study tests a 6-month online behavioral intervention (BIPAMS) aimed at increasing physical activity against a control condition (WELLMS). It will also assess improvements in mobility, cognition, symptoms and quality of life due to increased physical activity facilitated by changes in self-efficacy and goal setting.

How Is the Trial Designed?

Group I: BIPAMS Experimental Treatment 1 Intervention

The behavioral intervention consists of two primary components, a dedicated Internet website and one-on-one video chats with a behavioral coach via Skype. The behavioral intervention focuses on the skills, techniques, resources, and strategies for becoming and staying physically active with MS, but it does not provide a prescription for exercise or physical activity itself.

Group II: WELLMS Active Control 1 Intervention

The control condition provides an Internet website and one-on-one video chats that discuss materials about self-managing MS consequences and health indicators through methods other than physical activity.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Multiple Sclerosis Society

Collaborator

Trials

100

Recruited

10,600+

Citations

1. 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.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211034823004340

Randomized controlled trial of the behavioral intervention ... We reported that an e-learning approach increased moderate-to-vigorous physical activity among persons with multiple sclerosis. •. The e-learning approach was ...

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

Internet-Delivered Lifestyle Physical Activity Intervention for ... BIPAMS, Behavioral Intervention ... Cognitive function in multiple sclerosis improves with telerehabilitation: results from a randomized controlled trial.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04518657

Internet-Delivered Lifestyle Physical Activity Intervention for ... The secondary outcomes include an objective neuropsychological measure of learning and memory (California Verbal Learning Test-II) collected remotely via screen ...

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

BIPAMS-Cognition | College of Applied Health Sciences The BIPAMS-Cognition study consists of two different internet-delivered approaches for lifestyle behavior change for managing the consequences of MS and ...

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

Primary Results of a Phase-III, Randomized Controlled Trial of ... The mean number of valid days for the. Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS) condition was 6.0 (SD = 1.4),. 5.9 (SD = 1.5) ...