Mobile Subthreshold Exercise Program for Concussion

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Sara Chrisman，Seattle Children's Hospital

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 1, 2018

Last Update Posted Date

October 1, 2018

Actual Study Start Date ^ICMJE

March 6, 2018

Estimated Primary Completion Date

September 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in Health Behavior Inventory (HBI)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]

Self-report questionnaire regarding concussive symptoms

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Change in Pediatric Quality of Life Inventory (PedsQL)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report questionnaire regarding Health-related quality of life
Change in Fear of pain questionnaire (FOPQ)-P/C, adapted for concussion[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
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)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report questionnaire of depression symptoms
Change in PROMIS Positive affect[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report questionnaire of positive mood levels
Change in moderate to vigorous physical activity (MVPA)[ Time Frame: Change from baseline to 6 weeks ]
Average minutes per day of MVPA, measured using hip-mounted accelerometry
Change in Adolescent Sleep Wake Scale (ASWS)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report 10-item questionnaire regarding difficulty falling asleep, night wakenings and other sleep issues
Change in Sport participation questionnaire[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report questionnaire regarding sporting and recreational activities that a youth participated in that week
Change in Physical activity parenting[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report questionnaire (completed by parents) regarding their approach to physical activity with their child.
Change in Adult responses to child's symptoms (ARCS), adapted for concussion[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report questionnaire regarding parenting responses to child's concussive symptoms
Change in Generalized anxiety disorder--7 item (GAD7)[ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
Self-report questionnaire regarding anxiety symptoms (7-item)

Descriptive Information

Brief Title ^ICMJE

Mobile Subthreshold Exercise Program for Concussion

Official Title ^ICMJE

Mobile Subthreshold Exercise Program (M-STEP) for Concussion

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: All youth will receive the intervention
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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.

Study Arms

Experimental: M-STEP
Mobile exercise intervention

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 1, 2019

Estimated Primary Completion Date

September 1, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

9 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Sara Chrisman，Seattle Children's Hospital

Study Sponsor ^ICMJE

Seattle Children's Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Sara PD Chrisman, MD, MPH Seattle Children's Research Institute

PRS Account

Seattle Children's Hospital

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名