Physical Therapy for Multiple Sclerosis

(PromPT-MS Trial)

Overseen By Dominique Kinnett-Hopkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 24 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new physical therapy program called PromPT-MS, designed to help people with multiple sclerosis (MS) become more active. The goal is to determine if regular exercise can help manage symptoms such as fatigue. Participants receive personalized support through physical therapy sessions and educational materials. Individuals with MS who frequently experience fatigue and are not currently very active may be well-suited for this study. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing MS symptoms.

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 therapy and exercise, so it's best to discuss your medications with the study team.

What prior data suggests that this physical therapy intervention is safe for people with multiple sclerosis?

Research shows that physical therapy and exercise programs for people with multiple sclerosis (MS) are generally safe. Studies have found that participants tolerate these activities well. For instance, one study discovered that a home-based exercise program for MS patients had no serious side effects and was considered safe.

The PromPT-MS trial is a physical therapy program designed to increase physical activity without using any drugs. Because no medications are involved, the risk of side effects is low. Physical therapy usually includes exercises that are safe and manageable for people with MS. These programs have been used in other studies and are known to help with MS symptoms like fatigue.

In summary, physical therapy programs like PromPT-MS are generally safe for people with MS, with no reports of significant adverse events in similar research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PromPT-MS treatment for multiple sclerosis because it focuses on a non-drug approach to therapy. Unlike standard treatments that often rely on medications to manage symptoms, PromPT-MS emphasizes a 24-week progressive exercise program supported by personalized physical therapy sessions. This method is designed to increase physical activity with guidance tailored to meet recommended fitness guidelines, potentially enhancing mobility and quality of life without the side effects commonly associated with medications. By incorporating educational materials based on social cognitive theory, this treatment also empowers participants to take an active role in managing their condition.

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

Research has shown that physical therapy can help people with Multiple Sclerosis (MS) walk better and improve their balance. Studies indicate that exercise enhances mobility, reduces fatigue, increases strength, and improves overall quality of life and cardiovascular fitness for those with MS. This trial will evaluate the PromPT-MS program, where participants in the experimental arm will undergo a 24-week progressive exercise intervention supported by physical therapy visits and educational material. An active approach to physical therapy may help people remain more physically active, leading to better daily functioning and a higher quality of life. Early findings suggest that these exercise programs are both effective and practical for people with MS. ^{1 2 4 6 7}

Who Is on the Research Team?

Dominique Kinnett-Hopkins, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Sclerosis who are not currently very active. The goal is to see if a special physical therapy program can help them exercise more.

Inclusion Criteria

Access to a smartphone

Not sufficiently active as measured by the Godin Leisure Time Exercise Questionnaire score <24

Less than 2 affirmative on the physical activity readiness questionnaire

Exclusion Criteria

Inability to provide informed consent (e.g., cognitive impairment, unable to sufficiently communicate in English)

Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol.

I cannot attend the study visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 24-week progressive exercise intervention supported by physical therapy visits and educational material

24 weeks

6 visits (in-person)

Follow-up

Participants are monitored for sustained treatment effects and complete assessments at 10 months

4 months

What Are the Treatments Tested in This Trial?

Interventions

• PromPT-MS

Trial Overview The study tests 'PromPT-MS', a consultative physical therapy intervention designed to encourage people with MS to engage in more physical activity and manage symptoms like fatigue.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

The experimental intervention is a 24-week progressive exercise intervention in which participants are supported through six physical therapy visits and are provided with educational material based on social cognitive theory. The individual sessions will provide tailored support for increasing physical activity behavior towards the recommended guidelines of 2-3 moderate aerobic activity sessions and two strength-training sessions per week. There are no drugs involved in the intervention.

Group II: Waitlist Control Active Control 1 Intervention

24-week waitlist control condition

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

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 survey of 500 adults with multiple sclerosis revealed that 90% of respondents were interested in participating in a novel physical therapy program called lower extremity constraint-induced therapy (LE CIT), indicating strong acceptability of the treatment.

The majority of participants (median=88%) expressed a positive attitude towards key procedures of LE CIT, especially those who had prior experience with physical therapy, suggesting that this program could effectively enhance mobility and community use of lower extremities for individuals with MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives From Persons With Multiple Sclerosis for a Comprehensive Real-World Change Therapy for Mobility. Mark, VW., Lee, RD., Taub, E., et al.[2022]

A retrospective review of 500 medical records from MS patients showed that physical therapy significantly improved fatigue and mobility in ambulatory patients, as measured by the Modified Fatigue Impact Scale (MFIS) and Ambulation Index (AI).

The study found that the MFIS is a reliable outcome measure for assessing treatment efficacy in ambulatory MS patients, but neither the MFIS nor the AI were effective in measuring outcomes for non-ambulatory patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of physical therapy in multiple sclerosis as measured with the modified fatigue impact scale and ambulation index: a retrospective study. Brichetto, G., Rinaldi, S., Spallarossa, P., et al.[2019]

In a study of 1,065 adults with multiple sclerosis aged 45 to 90, 36% reported never using physical therapy services, highlighting a significant gap in service utilization among this population.

Factors influencing the use of physical therapy included living in urban areas, worsening MS symptoms, mobility issues, and recent hospitalizations, indicating that access and health status are critical in determining the need for these services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of physical therapy services among middle-aged and older adults with multiple sclerosis. Finlayson, M., Plow, M., Cho, C.[2022]

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]

A study involving 30 participants with Multiple Sclerosis showed that a telerehabilitation (TR) program is a feasible alternative to conventional physical therapy, lasting 8 weeks and conducted via real-time telecommunication.

The TR program demonstrated comparable efficacy to in-person physical therapy, as both methods led to improvements in gait and balance without significant differences in patient-reported outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telerehabilitation in Multiple Sclerosis: Results of a Randomized Feasibility and Efficacy Pilot Study. Fjeldstad-Pardo, C., Thiessen, A., Pardo, G.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06933160

Promotion of Exercise Through Physical Therapy for ... A proactive physical therapy delivery model may help persons with multiple sclerosis increase and maintain their physical activity and exercise behaviors. The ...

2. withpower.com withpower.com/trial/physical-therapy-for-multiple-sclerosis-c7f38

Physical Therapy for Multiple Sclerosis (PromPT-MS Trial) Research shows that physical therapy, including telerehabilitation, can improve gait and balance in people with Multiple Sclerosis, and is as effective as in- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5695400/

protocol of a randomised controlled feasibility trial (iStep-MS) There is substantial evidence that exercise interventions improve mobility, fatigue, strength, quality of life and cardiorespiratory fitness in people with MS ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0361923025003776

Exercise-induced exerkines in Multiple Sclerosis Overall, evidence from human studies indicates that exercise not only enhances symptomatic and functional results in MS but also positively ...

5. ijmsc.org ijmsc.org/view/consultative-proactive-physical-therapy-in-early-multiple-sclerosis

Consultative, Proactive Physical Therapy in Early Multiple ... This case series supports the feasibility of using PAPT to increase exercise participation and improve functional and patient-reported outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7575303/

Exercise and lifestyle physical activity recommendations for ... Objectives: To provide clinicians who treat multiple sclerosis (MS) patients with evidence-based or expert opinion–based recommendations for promoting exercise ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002696

Implementing changing behaviour towards aerobic and ... This four-month, randomised, phase one clinical trial assessed the feasibility and safety of a home-based exercise training program delivered remotely online by ...