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Mobile Subthreshold Exercise Program for Concussion (M-STEP)

Primary Purpose

Brain Concussion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
M-STEP
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Concussion focused on measuring child, Adolescent, exercise, rehabilitation, physical activity, virtual, mobile health

Eligibility Criteria

9 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

M-STEP

Arm Description

Mobile exercise intervention

Outcomes

Primary Outcome Measures

Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms
Self-report questionnaire regarding concussive symptoms

Secondary Outcome Measures

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
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
Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms
Self-report questionnaire of depression symptoms
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
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)
Study Satisfaction Questionnaire
8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction

Full Information

First Posted
September 27, 2018
Last Updated
January 4, 2021
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03691363
Brief Title
Mobile Subthreshold Exercise Program for Concussion
Acronym
M-STEP
Official Title
Mobile Subthreshold Exercise Program (M-STEP) for Concussion
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion
Keywords
child, Adolescent, exercise, rehabilitation, physical activity, virtual, mobile health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All youth will receive the intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M-STEP
Arm Type
Experimental
Arm Description
Mobile exercise intervention
Intervention Type
Behavioral
Intervention Name(s)
M-STEP
Other Intervention Name(s)
Sub-threshold exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms
Description
Self-report questionnaire regarding concussive symptoms
Time Frame
Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Secondary Outcome Measure Information:
Title
Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function
Description
Self-report questionnaire regarding Health-related quality of life
Time Frame
Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Title
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
Description
Self-report questionnaire completed by parent and child regarding their fear of concussive symptoms and avoidance of activities that might produce concussive symptoms
Time Frame
Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Title
Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms
Description
Self-report questionnaire of depression symptoms
Time Frame
Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Title
Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality
Description
Self-report 10-item questionnaire regarding difficulty falling asleep, night wakenings and other sleep issues
Time Frame
Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Title
Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms
Description
Self-report questionnaire regarding anxiety symptoms (7-item)
Time Frame
Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Title
Study Satisfaction Questionnaire
Description
8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara PD Chrisman, MD, MPH
Organizational Affiliation
Seattle Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34123963
Citation
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.
Results Reference
derived

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Mobile Subthreshold Exercise Program for Concussion

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