NCT03691363

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

September 27, 2018

Last Update Submit

January 4, 2021

Conditions

Brain Concussion

Keywords

childAdolescentexerciserehabilitationphysical activityvirtualmobile health

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function

    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

    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

    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

    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

    Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)

  • +1 more secondary outcomes

Study Arms (1)

M-STEP

EXPERIMENTAL

Mobile exercise intervention

Behavioral: M-STEP

Interventions

M-STEPBEHAVIORAL

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.

Also known as: Sub-threshold exercise
M-STEP

Eligibility Criteria

Age9 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- Already participating in \>30 minutes of MVPA/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 34123963DERIVED

MeSH Terms

Conditions

Brain ConcussionMotor Activity

Interventions

SE 1-step Futurabond M

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingBehavior

Study Officials

  • Sara PD Chrisman, MD, MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All youth will receive the intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 1, 2018

Study Start

March 6, 2018

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

January 6, 2021

Record last verified: 2021-01

Locations

US(1)