MSTEP for Concussion

(MSTEP-R01 Trial)

Overseen By Sara P Chrisman, MD MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Non-English, Other injuries, High activity, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an exercise program delivered through telehealth to assist young people with ongoing symptoms after a concussion. The goal is to determine if gradually increasing physical activity, aided by fitness trackers and weekly online meetings, can reduce symptoms such as headaches and trouble focusing. Participants will either follow the Mobile Subthreshold Exercise Program (MSTEP) or a stretching routine to identify which is more effective. This trial suits youth aged 11-18 who have had a concussion in the past year and still experience at least three symptoms, such as headaches or dizziness. All activities can be done from home, ensuring accessibility regardless of location. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance recovery strategies for young people experiencing post-concussion 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 focuses on using exercise to treat concussion symptoms.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Mobile Subthreshold Exercise Program (MSTEP) is practical and well-received by young people with concussions. In early studies, participants experienced a quicker reduction in concussion symptoms when they engaged in this exercise program delivered through telehealth. The MSTEP involves gradually increasing physical activity, which helps lessen symptoms over time.

The program also uses personal fitness devices like Fitbits to track exercise levels, which participants have managed well. This method aids physical recovery and addresses mental aspects, such as reducing the fear of symptoms. While these early results are encouraging, further research is underway to ensure the treatment's safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for concussions that often focus on rest and symptom management, the MSTEP approach offers a proactive rehabilitation method. This treatment involves a structured, gradually intensifying exercise regimen that's monitored via video conference, aiming to reach 60 minutes of moderate to vigorous physical activity (MVPA) each day. Researchers are excited because this method encourages active recovery, potentially speeding up healing by safely pushing the body's limits and using real-time feedback from a fitness tracker. This could shift the paradigm from passive recovery to an active, engaging process, offering new hope for quicker and more effective concussion rehabilitation.

What evidence suggests that this trial's treatments could be effective for PPCS?

Research has shown that the Mobile Subthreshold Exercise Program (MSTEP), which participants in this trial may receive, can help reduce symptoms in young people with ongoing post-concussion issues. In early studies, participants experienced a significant reduction in symptoms and felt less anxious about them over a 6-week period. This program involves moderate exercise that children can perform at home, guided through video calls. Gradually increasing physical activity aims to aid brain healing after a concussion. This method shows promise for managing symptoms without frequent in-person visits to specialists. ^{1 3 4 6 7}

Who Is on the Research Team?

Sara P Chrisman, MD

Principal Investigator

University of Washington and Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking youth aged 11-18 with persistent post-concussive symptoms from a concussion diagnosed between 1 week to 12 months prior. Participants must have at least three concussive symptoms and minimal current physical activity. Those already cleared for sports or treated by a Physical Therapist for aerobic activity are excluded.

Inclusion Criteria

I can participate from anywhere since the study is conducted remotely.

I have had at least 3 concussion symptoms with a severity of 2 or more and a total score of 10 or higher.

I had a concussion diagnosed by a professional between 1 week and 12 months ago.

Exclusion Criteria

Children who have worked with a physical therapist to improve their cardiovascular exercise.

I have been advised against moderate to vigorous physical activity due to other injuries or medical conditions.

Children who say they are doing at least 30 minutes of heart-pumping exercise each day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the M-STEP intervention or stretching control for 6 weeks, with weekly video conferencing and use of Fitbits for progress tracking

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

6 months

3 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• MSTEP
• Stretching

Trial Overview The 'Mobile Subthreshold Exercise Program' (M-STEP) is being tested, which uses Fitbits and weekly video calls to guide youths with post-concussion syndrome through rehabilitative exercises remotely, aiming to improve their symptoms more rapidly than standard care.

How Is the Trial Designed?

Group I: Intervention group (MSTEP) Experimental Treatment 1 Intervention

REHABILITATIVE EXERCISE: Participants will be asked to exercise at home daily for 6 weeks, meeting with an RA weekly via video conference to gradually increase the intensity and duration of exercise based on symptom tolerance. The eventual goal will be to achieve 60 minutes of MVPA daily (US Federal recommendations). They will wear a personal fitness device (Fitbit) to track whether they are achieving their HR goals.

Group II: Control group (Stretching) Active Control 1 Intervention

STRETCHING: Participants will be asked to complete stretches daily. They will initially be given two stretches, primarily focused on the neck and upper back. Additional stretches will be added through weekly discussions with the study RA.

MSTEP is already approved in United States, Canada for the following indications:

Approved in United States as M-STEP for:

• Persistent Post-Concussive Symptoms (PPCS)

Approved in Canada as M-STEP for:

• Persistent Post-Concussive Symptoms (PPCS)

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

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 study involving 12 patients with post-concussion syndrome showed that subsymptom threshold exercise training is safe and leads to significant improvements in exercise capacity and reduction of PCS symptoms over 2 to 3 weeks.

Participants were able to exercise longer and at higher heart rates without exacerbating symptoms, with athletes recovering faster than nonathletes, indicating that controlled exercise can be an effective treatment for PCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. Leddy, JJ., Kozlowski, K., Donnelly, JP., et al.[2022]

The Montreal Virtual Exertion (MOVE) protocol is a safe and feasible graded exertion test for both healthy children and those with subacute concussion, as no adverse events were reported during the study.

Increases in heart rate and perceived exertion were similar between the MOVE protocol and the traditional Buffalo Concussion Treadmill Test, suggesting that MOVE can effectively assess exertion levels without the need for expensive equipment or in-person supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An At-Home, Virtually Administered Graded Exertion Protocol for Use in Concussion Management: Preliminary Evaluation of Safety and Feasibility for Determining Clearance to Return to High-Intensity Exercise in Healthy Youth and Children With Subacute Concussion. Teel, E., Alarie, C., Swaine, B., et al.[2023]

A structured aerobic exercise intervention (SAEP) significantly reduced the time to reach asymptomatic status and medical clearance in adolescents and young adults recovering from sport-related concussions, compared to usual care exercise prescriptions (UCEP).

The SAEP group experienced consistently lower symptom severity scores throughout the trial, indicating that this exercise protocol is both safe and effective for early intervention following a concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of early aerobic exercise following sport-related concussion: Progressive percentage of age-predicted maximal heart rate versus usual care. Hutchison, MG., Di Battista, AP., Lawrence, DW., et al.[2023]

Subthreshold aerobic exercise significantly reduces symptom scores in individuals with concussion, but it does not shorten the time to recovery, based on a systematic review of 12 trials.

Individually tailored multimodal interventions, which include cervical, vestibular, and oculomotor therapies, show a moderate effect in improving symptom scores and help concussed individuals with persistent symptoms return to sport more quickly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do physical interventions improve outcomes following concussion: a systematic review and meta-analysis? Reid, SA., Farbenblum, J., McLeod, S.[2022]

In a study of 14 adults with persistent concussion symptoms, a 6-month supervised home exercise program combining vestibular rehabilitation and aerobic training led to significant improvements in concussion-related symptoms and functional abilities, as measured by various clinical assessments.

Participants showed notable progress in returning to work and engaging in meaningful activities, with statistical significance in measures related to symptom reduction and balance confidence, indicating the effectiveness of this rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes Following a Vestibular Rehabilitation and Aerobic Training Program to Address Persistent Post-Concussion Symptoms. Moore, BM., Adams, JT., Barakatt, E.[2018]

The Mobile Subthreshold Exercise Program (MSTEP) is being tested in a large national randomized controlled trial involving 200 adolescents aged 11-18 with persistent postconcussive symptoms, aiming to assess its effectiveness in reducing symptoms and improving quality of life over 6 weeks.

This study will not only evaluate the primary outcomes of concussive symptoms and health-related quality of life but also explore secondary outcomes like depression and anxiety, providing comprehensive insights into the benefits of virtual subthreshold exercise for youth with PPCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial. Chrisman, SPD., Bollinger, BJ., Mendoza, JA., et al.[2023]

The Mobile Subthreshold Exercise Program (MSTEP) delivered via telehealth was found to be feasible and acceptable for youth with concussions, with 79% of participants completing the program and reporting high satisfaction with their care.

Participants showed significant improvements in concussive symptoms, fear-avoidance, and health-related quality of life over the 6-week intervention, indicating that this remote exercise program may effectively aid recovery from concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). Chrisman, SPD., Mendoza, JA., Zhou, C., et al.[2021]

A study of 126 patients with acute sport-related concussions showed that supervised exercise (SE) initiated within 16 days of injury was safe, with no serious adverse events reported.

Early SE was linked to a significantly quicker return to sport, with patients returning in an average of 26.5 days compared to 35.1 days for those who did not undergo early SE, suggesting it may help speed up recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Supervised Exercise During Recovery Following Sports-Related Concussion. Popovich, M., Almeida, A., Freeman, J., et al.[2021]

The 3-minute Kasch Pulse Recovery test (KPR) demonstrated high sensitivity (100%) and specificity (95.7%) in assessing readiness for graded exercise in children and adolescents with concussion, based on a study of 45 participants aged 8 to 18 years.

There is a strong association between activity readiness determined by the KPR and the graded exercise test (GXT), indicating that the KPR can effectively guide decisions on when to safely start exercise after a concussion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Simple Step Test With Readiness for Exercise in Youth After Concussion. Fyffe, A., Bogg, T., Orr, R., et al.[2021]

Aerobic exercise is increasingly recognized as a beneficial rehabilitation technique for individuals recovering from concussions, as it can help reduce symptoms and improve overall function.

The review highlights that while exercise is promising, the optimal parameters for recovery—such as frequency, duration, and intensity—are still not well defined, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Howell, DR., Taylor, JA., Tan, CO., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35473570/

Mobile Subthreshold Exercise Program (MSTEP) for concussion This multisite RCT of MSTEP will provide vital information regarding the efficacy of a virtually delivered subthreshold exercise program for youth with PPCS.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04688255

Mobile Subthreshold Exercise Program for Concussion--R01 Data will be analyzed using mixed effects models to examine differences between experimental groups in the primary outcome, trajectory of concussive symptoms, ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06239-3

Mobile Subthreshold Exercise Program (MSTEP) for concussion This multisite RCT of MSTEP will provide vital information regarding the efficacy of a virtually delivered subthreshold exercise program for youth with PPCS.

4. frontiersin.org frontiersin.org/journals/pediatrics/articles/10.3389/fped.2021.645814/full

Pilot Study of Telehealth Delivered Rehabilitative Exercise ... Concussive symptoms (HBI) decreased significantly over the 6 week intervention (−10.6, 95%CI: −16.0 to −5.1) as did fear-avoidance (−21.6, 95%CI: −29.8 to −13.5) ...

5. withpower.com withpower.com/trial/phase-brain-injuries-2-2021-8429f

MSTEP for Concussion · Info for Participants Subthreshold aerobic exercise significantly reduces symptom scores in individuals with concussion, but it does not shorten the time to recovery, based on a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9040347/

Mobile Subthreshold Exercise Program (MSTEP) for concussion The primary outcomes will be trajectory of concussive symptoms and health-related quality of life over the 6 months of the study. Secondary outcomes will ...

7. clinicaltrial.be clinicaltrial.be/en/details/49281?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Mobile Subthreshold Exercise Program for Concussion Youth will be followed for a total of 6 months. Data will be analyzed using mixed effects models to examine differences between experimental ...