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

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new exercise program called M-STEP that uses fitness trackers and video calls to help young people aged 11-18 recover from long-lasting concussion symptoms. The program aims to speed up recovery by gradually increasing physical activity and reducing fear of 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 the Mobile Subthreshold Exercise Program (MSTEP) safe for use in humans?

Research indicates that subthreshold exercise programs, including MSTEP, are generally safe for individuals with concussion, as no adverse events were recorded in studies involving both healthy youth and those with concussion. ^{1 2 3 4 5}

How is the MSTEP treatment for concussion different from other treatments?

MSTEP is unique because it delivers subthreshold exercise (exercise below the level that causes symptoms) virtually through telehealth, using tools like Zoom and fitness devices, making it accessible for youth in rural areas or during situations like the COVID-19 pandemic, unlike traditional treatments that require in-person visits. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment MSTEP for concussion?

Research suggests that subsymptom threshold exercise, which is part of the MSTEP program, can help reduce symptoms and improve recovery in people with persistent post-concussion symptoms. Studies have shown that structured aerobic exercise and physical interventions can lead to faster recovery and symptom improvement after a concussion. ^{1 2 8 9 10}

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]

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]

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]

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 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 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 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]

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]

Citations

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

A preliminary study of subsymptom threshold exercise training for refractory post-concussion syndrome. [2022]

2. United States 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. [2023]

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

Do physical interventions improve outcomes following concussion: a systematic review and meta-analysis? [2022]

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

Outcomes Following a Vestibular Rehabilitation and Aerobic Training Program to Address Persistent Post-Concussion Symptoms. [2018]

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

The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial. [2023]

7. United States 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. [2023]

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

Use of Supervised Exercise During Recovery Following Sports-Related Concussion. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). [2021]

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

Association of Simple Step Test With Readiness for Exercise in Youth After Concussion. [2021]