Mobile Subthreshold Exercise Program for Concussion (M-STEP)

Mobile Subthreshold Exercise Program (M-STEP) for Concussion

Non-randomized pilot intervention using mobile-administered sub-threshold exercise to treat youth with prolonged symptoms of concussion.

Study Overview

• Status: Completed
• Conditions: Brain Concussion
• Intervention / Treatment: Behavioral: M-STEP

Detailed Description

6-week pilot study of a novel intervention for concussion, administering a sub-threshold exercise program in a mobile fashion using video conferencing and providing feedback using wrist-worn accelerometry and heart rate monitoring.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Concussion diagnosed by a healthcare provider that occurred 2 weeks-6 months ago
• Continued symptoms with at least 3 symptoms on the HBI and a score of 20+
• No other issues that would preclude physical activity
• Parents and youth are English-speaking

Exclusion Criteria:

- Already participating in >30 minutes of MVPA/day

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: M-STEP; Mobile exercise intervention

Behavioral: M-STEP; Youth will be assessed using actigraphy at baseline, and will then be asked to exercise for 1) a duration of 10 minutes > MVPA at baseline with 2) HR>120 while being monitored by a Fitbit. Youth will be asked to exercise daily, and intensity and duration will be increased every few days for a goal of 60 minutes per day at a HR>140 (low end of MVPA). The intervention will be 6 weeks in duration.; Other Names: Sub-threshold exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms	Self-report questionnaire regarding concussive symptoms	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function	Self-report questionnaire regarding Health-related quality of life	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Fear of pain questionnaire (FOPQ)-P/C, adapted for concussion, 24 item (child) and 23 item (parent) 0-4 likert, higher scores indicate greater fear-avoidance	Self-report questionnaire completed by parent and child regarding their fear of concussive symptoms and avoidance of activities that might produce concussive symptoms	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms	Self-report questionnaire of depression symptoms	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality	Self-report 10-item questionnaire regarding difficulty falling asleep, night wakenings and other sleep issues	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms	Self-report questionnaire regarding anxiety symptoms (7-item)	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Study Satisfaction Questionnaire	8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction	6 weeks

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Principal Investigator: Sara PD Chrisman, MD, MPH, Seattle Children's Research Institute

Publications and helpful links

General Publications

• Chrisman SPD, Mendoza JA, Zhou C, Palermo TM, Gogue-Garcia T, Janz KF, Rivara FP. Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). Front Pediatr. 2021 May 28;9:645814. doi: 10.3389/fped.2021.645814. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 1, 2018

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Adolescent; physical activity; exercise; rehabilitation; mobile health; child; virtual
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 00001039

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No