Mobile Subthreshold Exercise Program for Concussion--R01

NCT04688255 | Active Not Recruiting DMC

• 2 other identifiers: 000026971R01HD094722-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 1.9 million youth sustain a concussion each year, and up to 30% experience persistent post-concussive symptoms (PPCS) such as headache, dizziness, and difficulty focusing that continue for weeks or months. PPCS results in greater utilization of sub-specialty care and can impact immediate and long-term social development, cognitive function and academic success. Previous recommendations for treating PPCS have focused on cognitive and physical rest, but more recently guidelines have shifted based on new research suggesting the benefit of rehabilitative exercise for PPCS. The rationale behind using exercise to treat youth with concussion is that gradually increasing physical activity facilitates return to full function. Rehabilitative exercise has since become one of the most common approaches to treating youth with PPCS, but access is challenging since most programs require weekly centralized visits with a concussion specialist. To bridge this gap, the investigators developed a telehealth-delivered approach to treat PPCS, utilizing physical activity trackers (Fitbits) and weekly video conferences with trained research staff. They then conducted a series of pilot studies with this approach, finding excellent feasibility, acceptability, and evidence for more rapid declines in concussive symptoms compared to controls. The investigators also found preliminary evidence that mechanisms behind this intervention may stem from both physiologic processes due to increased moderate-to-vigorous physical activity (MVPA) and psychologic processes such as reducing fear- avoidance of concussive symptoms. They now propose a fully-powered randomized controlled trial (RCT) to asses the efficacy of the "Mobile Subthreshold Exercise Program" (M-STEP) for treating youth with PPCS.

Conditions

Concussion, Brain; Concussion, Mild; Brain Injuries, Traumatic; Persistent Post Traumatic Headache; Post-Concussion Syndrome; Post-Concussive Syndrome, Chronic

Keywords

Traumatic brain injury; Concussion; Exercise; Physical activity; Subthreshold; Treatment; Pediatric; Child

Outcome Measures

Primary Outcomes (2)

• Concussive symptoms (Health Behavior Inventory, HBI)--youth, a 21 item 0-3 likert scale with higher scores indicating more severe symptoms

  Examine trajectory of concussive symptoms over time. The central hypothesis is that the intervention group will have a more rapid decline in concussive symptoms..

  Baseline, weekly during the intervention (x6 weeks), 3 months and 6 months.

• Pediatric Quality of Life (PEDsQL, parent and youth), a 23 item 0-4 likert scale that is scaled to 0-100 with higher scores indicating better function

  Examine trajectory of concussive symptoms over time. The central hypothesis is that the intervention group will have a more rapid improvement in health-related quality of life.

  Baseline, 6 weeks, 3 months and 6 months.

Secondary Outcomes (2)

• Fear of Pain Questionnaire (FOPQ, parent and youth), adapted for concussive symptoms, 24 item (child) and 23 item (parent) 0-4 likert scales with higher scores indicating greater fear-avoidance

  Baseline, 6 weeks, 3 months and 6 months.

• Moderate-Vigorous Physical Activity (MVPA), measured with hip-mounted actigraphy

  Baseline, 6 weeks, 3 months

Other Outcomes (3)

• Patient Health Questionnaire-9 (PHQ-9), standardized measure of depressive symptoms, a 9-item 0-3 likert scale with higher scores indicating more severe symptoms

  Baseline, 6 weeks, 3 months, 6 months

• Generalized Anxiety Disorder Scale-7 (GAD-7), standardized measure of anxiety symptoms, a 7-item 0-3 likert scale with higher scores indicating more severe symptoms

  Baseline, 6 weeks, 3 months, 6 months

• Adolescent Sleep Wake Scale (ASWS)-10, standardized survey (self-report) regarding sleep quality, a 10-item 0-5 likert scale reported as the mean with higher scores indicating improved sleep quality

  Baseline, 6 weeks, 3 months, 6 months

Study Arms (2)

Intervention group (MSTEP)

EXPERIMENTAL

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.

Behavioral: MSTEP

Control group (Stretching)

ACTIVE COMPARATOR

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.

Behavioral: Stretching

Interventions

MSTEP BEHAVIORAL

Aerobic exercise that is advanced weekly

Intervention group (MSTEP)

Stretching BEHAVIORAL

Stretching exercises that are advanced weekly

Control group (Stretching)

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth 11-18 years
• Concussion occurring 1 week to 12 months prior to the start of the study and diagnosed by a clinician trained in concussion management consistent with the 2017 Berlin consensus definition of concussion ("A traumatic brain injury, induced by biomechanical forces")
• Persistent post-concussive symptoms as defined by the presence of at least 3 concussive symptoms rated at least 2 or greater on the Health and Behavior Inventory (HBI) and a total score of at least 10
• Can be located anywhere as all study procedures are remote

You may not qualify if:

• Youth not fluent in English or at least one Parent not fluent in English or Spanish
• Other injuries or medical conditions in addition to concussion that have prompted a clinician to recommend against MVPA, such as concerning abnormalities on routine brain imaging
• Youth who indicate that they are completing an average of 30 minutes per day or greater of physical activity that increases their heart rate (indicative of a minimal need for a physical activity intervention)
• Youth who have previously engaged with a Physical Therapist to increase aerobic activity
• Youth who have been fully cleared for sport

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Seattle Childrens Hospital

Seattle, Washington, 98104, United States

Location

Related Publications (4)

• Chrisman SPD, Whitlock KB, Mendoza JA, Burton MS, Somers E, Hsu A, Fay L, Palermo TM, Rivara FP. Pilot Randomized Controlled Trial of an Exercise Program Requiring Minimal In-person Visits for Youth With Persistent Sport-Related Concussion. Front Neurol. 2019 Jun 17;10:623. doi: 10.3389/fneur.2019.00623. eCollection 2019. Erratum In: Front Neurol. 2020 Feb 21;11:6. doi: 10.3389/fneur.2020.00006.

  PMID: 31316446 BACKGROUND

• Chrisman SPD, Whitlock KB, Somers E, Burton MS, Herring SA, Rowhani-Rahbar A, Rivara FP. Pilot study of the Sub-Symptom Threshold Exercise Program (SSTEP) for persistent concussion symptoms in youth. NeuroRehabilitation. 2017;40(4):493-499. doi: 10.3233/NRE-161436.

  PMID: 28222566 BACKGROUND

• Chrisman SPD, Zhou C, Sahlberg J, Bollinger BJ, Hansen C, Mendoza JA, Brooks MA, Rivara FP, Palermo TM. Psychometrics of a fear-avoidance measure adapted for youth with persistent postconcussive symptoms: Fear of Concussive Symptoms Questionnaire (FOCSQ) child and parent-proxy versions. Neuropsychology. 2025 Oct 2. doi: 10.1037/neu0001031. Online ahead of print.

  PMID: 41037445 DERIVED

• Chrisman SPD, Bollinger BJ, Mendoza JA, Palermo TM, Zhou C, Brooks MA, Rivara FP. Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial. Trials. 2022 Apr 26;23(1):355. doi: 10.1186/s13063-022-06239-3.

  PMID: 35473570 DERIVED

Related Links

• Website with more information about the study for potential participants

MeSH Terms

Conditions

Brain Concussion; Brain Injuries, Traumatic; Post-Concussion Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavior

Study Officials

• Sara P Chrisman, MD MPH

  University of Washington and Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using an active control (stretching) and both arms described as exercise intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial (RCT)

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 29, 2020
• Study Start: March 22, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)