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Completed

NCT Number: NCT03691363

Mobile Subthreshold Exercise Program for Concussion

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

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Key information

Conditions

Brain Concussion Behavior Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Motor Activity Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

9 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seattle Children's Hospital

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M-STEP

Behavioral

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

Primary outcomes

  1. Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptoms

    Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)

    Self-report questionnaire regarding concussive symptoms

Secondary outcomes

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

    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, 24 item (child) and 23 item (parent) 0-4 likert, higher scores indicate greater fear-avoidance

    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), 9 item 0-3 likert, higher scores indicate greater symptoms

    Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)

    Self-report questionnaire of depression symptoms

  4. Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality

    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

  5. Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms

    Time frame: Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)

    Self-report questionnaire regarding anxiety symptoms (7-item)

  6. Study Satisfaction Questionnaire

    Time frame: 6 weeks

    8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Registry information

Official study title

Mobile Subthreshold Exercise Program (M-STEP) for Concussion

Acronym: M-STEP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2018
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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