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Mobile Subthreshold Exercise Program for Concussion (M-STEP)

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ClinicalTrials.gov Identifier: NCT03691363
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Chrisman, Seattle Children's Hospital

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

Condition or disease Intervention/treatment Phase
Brain Concussion Behavioral: M-STEP Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All youth will receive the intervention
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile Subthreshold Exercise Program (M-STEP) for Concussion
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


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 Name: Sub-threshold exercise




Primary Outcome Measures :
  1. Change in Health Behavior Inventory (HBI) [ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
    Self-report questionnaire regarding concussive symptoms


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Change in PROMIS Positive affect [ Time Frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks) ]
    Self-report questionnaire of positive mood levels

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691363


Contacts
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Contact: Nasira Sharma 206-884-1533 mstep@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98104
Contact: Sara Chrisman, MD, MPH    206-987-2028    sara.chrisman@seattlechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
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Principal Investigator: Sara PD Chrisman, MD, MPH Seattle Children's Research Institute

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Responsible Party: Sara Chrisman, Assistant Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03691363     History of Changes
Other Study ID Numbers: 00001039
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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

Keywords provided by Sara Chrisman, Seattle Children's Hospital:
child
Adolescent
exercise
rehabilitation
physical activity
virtual
mobile health

Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating
Central Nervous System Diseases
Nervous System Diseases