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Mobile Subthreshold Exercise Program for Concussion--R01 (MSTEP-R01)

Primary Purpose

Concussion, Brain, Concussion, Mild, Brain Injuries, Traumatic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MSTEP
Stretching
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Brain focused on measuring Traumatic brain injury, Concussion, Exercise, Physical activity, Subthreshold, Treatment, Pediatric, Child

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Seattle Childrens HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group (MSTEP)

Control group (Stretching)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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..
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.

Secondary Outcome Measures

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
Examine trajectory of fear-avoidance over time and assess for mediation of change in concussive symptoms. The central hypothesis is that decreases in fear-avoidance of concussive symptoms will partially mediate the decline in concussive symptoms.
Moderate-Vigorous Physical Activity (MVPA), measured with hip-mounted actigraphy
Examine trajectory of MVPA over time and assess for mediation of change in concussive symptoms. The central hypothesis is that increases in MVPA will partially mediate the decline in concussive symptoms.

Full Information

First Posted
December 23, 2020
Last Updated
October 10, 2023
Sponsor
Seattle Children's Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04688255
Brief Title
Mobile Subthreshold Exercise Program for Concussion--R01
Acronym
MSTEP-R01
Official Title
Randomized Controlled Trial Using Telehealth-delivered Rehabilitative Exercise to Treat Youth With Prolonged Concussion Recovery (Mobile Subthreshold Exercise Program, MSTEP-R01)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
April 15, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The investigators will recruit n=200 youth 11-18 years old with PPCS. Youth will be randomized to 6 weeks of either usual care plus M-STEP (intervention) or usual care plus stretching (control). Youth in M-STEP will be coached through gradual increases in intensity and duration of rehabilitative exercise via weekly video conferencing (Zoom) and will use Fitbits to guide their progress. Youth in the stretching group will act as attention controls. All youth will complete research-grade measures at multiple time points. Youth will be followed for a total of 6 months. Data will be analyzed using mixed effects models to examine differences between experimental groups in the primary outcome, trajectory of concussive symptoms, and the secondary outcome, changes over time in health-related quality of life, on an intention-to-treat basis. Potential mediators of the treatment effect will also be examined, including fear-avoidance of concussive symptoms and MVPA, and explore the impact of factors such as patient sex and parental protective behaviors. The investigators thus assert the following hypotheses: Hypothesis 1: M-STEP youth will have more rapid declines in HBI and improvement in PedsQL compared to control youth Hypothesis 2: M-STEP youth will have greater increases in MVPA over time than control youth, and these increases will predict more rapid improvement in HBI and PedsQL. Hypothesis 3: M-STEP youth will have steeper declines in fear-avoidance compared to control youth, and these declines will predict more rapid improvement in HBI and PedsQL. IMPACT: The proposed study will definitively answer the question of whether a mobile sub-threshold exercise program (M-STEP) improves outcomes for youth with PPCS. It will also provide essential information about both the long-term impact of this intervention and potential mediators as well as biopsychosocial factors that influence treatment response. The study design uses a rigorous protocolized smartphone administered mHealth intervention that will be readily reproducible and generalizable to the majority of youth with PPCS. If successful, this will be one of the few evidenced-based interventions available to treat youth with PPCS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial (RCT)
Masking
ParticipantOutcomes Assessor
Masking Description
Using an active control (stretching) and both arms described as exercise intervention
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group (MSTEP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (Stretching)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MSTEP
Intervention Description
Aerobic exercise that is advanced weekly
Intervention Type
Behavioral
Intervention Name(s)
Stretching
Intervention Description
Stretching exercises that are advanced weekly
Primary Outcome Measure Information:
Title
Concussive symptoms (Health Behavior Inventory, HBI)--youth, a 21 item 0-3 likert scale with higher scores indicating more severe symptoms
Description
Examine trajectory of concussive symptoms over time. The central hypothesis is that the intervention group will have a more rapid decline in concussive symptoms..
Time Frame
Baseline, weekly during the intervention (x6 weeks), 3 months and 6 months.
Title
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
Description
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.
Time Frame
Baseline, 6 weeks, 3 months and 6 months.
Secondary Outcome Measure Information:
Title
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
Description
Examine trajectory of fear-avoidance over time and assess for mediation of change in concussive symptoms. The central hypothesis is that decreases in fear-avoidance of concussive symptoms will partially mediate the decline in concussive symptoms.
Time Frame
Baseline, 6 weeks, 3 months and 6 months.
Title
Moderate-Vigorous Physical Activity (MVPA), measured with hip-mounted actigraphy
Description
Examine trajectory of MVPA over time and assess for mediation of change in concussive symptoms. The central hypothesis is that increases in MVPA will partially mediate the decline in concussive symptoms.
Time Frame
Baseline, 6 weeks, 3 months
Other Pre-specified Outcome Measures:
Title
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
Description
Explore trajectory of depressive symptoms during the intervention. The central hypothesis is that depressive symptoms will decline during the intervention.
Time Frame
Baseline, 6 weeks, 3 months, 6 months
Title
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
Description
Explore trajectory of anxiety symptoms during the intervention. The central hypothesis is that anxiety symptoms will decline during the intervention.
Time Frame
Baseline, 6 weeks, 3 months, 6 months
Title
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
Description
Explore trajectory of self-reported sleep quality during the intervention. The central hypothesis is that sleep quality will improve during the intervention.
Time Frame
Baseline, 6 weeks, 3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara P Chrisman, MD MPH
Phone
206-884-1490
Email
sara.chrisman@seattlechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara P Chrisman, MD MPH
Organizational Affiliation
University of Washington and Seattle Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Childrens Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara P Chrisman, MD
Phone
206-884-1490
Email
sara.chrisman@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Beth Bollinger, PhD
Phone
206-659-8309
Email
mstep@seattlechildrens.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31316446
Citation
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.
Results Reference
background
PubMed Identifier
28222566
Citation
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.
Results Reference
background
PubMed Identifier
35473570
Citation
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.
Results Reference
derived
Links:
URL
http://mstepstudy.org
Description
Website with more information about the study for potential participants

Learn more about this trial

Mobile Subthreshold Exercise Program for Concussion--R01

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