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Mobile Subthreshold Exercise Program for Concussion

Mobile Subthreshold Exercise Program (M-STEP) for Concussion

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03691363
Acronym
M-STEP
Enrollment
19
Registered
2018-10-01
Start date
2018-03-06
Completion date
2019-09-01
Last updated
2021-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Concussion

Keywords

child, Adolescent, exercise, rehabilitation, physical activity, virtual, mobile health

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.

Interventions

BEHAVIORALM-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.

Sponsors

Seattle Children's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

All youth will receive the intervention

Eligibility

Sex/Gender
ALL
Age
9 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Health Behavior Inventory (HBI), 21 item 0-3 likert, higher scores indicate more severe symptomsTrajectory over 6 weeks (baseline, 3 weeks, 6 weeks)Self-report questionnaire regarding concussive symptoms

Secondary

MeasureTime frameDescription
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-avoidanceTrajectory 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), 9 item 0-3 likert, higher scores indicate greater symptomsTrajectory over 6 weeks (baseline, 3 weeks, 6 weeks)Self-report questionnaire of depression symptoms
Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved functionTrajectory over 6 weeks (baseline, 3 weeks, 6 weeks)Self-report questionnaire regarding Health-related quality of life
Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptomsTrajectory over 6 weeks (baseline, 3 weeks, 6 weeks)Self-report questionnaire regarding anxiety symptoms (7-item)
Study Satisfaction Questionnaire6 weeks8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction
Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep qualityTrajectory over 6 weeks (baseline, 3 weeks, 6 weeks)Self-report 10-item questionnaire regarding difficulty falling asleep, night wakenings and other sleep issues

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026