Mobile Subthreshold Exercise Program for Concussion

Brain Concussion Clinical Trial

— M-STEP  

Official title:

Mobile Subthreshold Exercise Program (M-STEP) for Concussion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03691363
• Other study ID #: 00001039
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2021
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Pediatric Quality of Life Inventory (PedsQL), 23 item 0-4 likert, converted to a 0-100 scale, higher scores indicate improved function	Self-report questionnaire regarding Health-related quality of life	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Secondary	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	Self-report questionnaire completed by parent and child regarding their fear of concussive symptoms and avoidance of activities that might produce concussive symptoms	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Secondary	Change in Patient Health Questionnaire 9 (PHQ-9), 9 item 0-3 likert, higher scores indicate greater symptoms	Self-report questionnaire of depression symptoms	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Secondary	Change in Adolescent Sleep Wake Scale (ASWS), 10-item 0-5 likert, higher scores indicate improved sleep quality	Self-report 10-item questionnaire regarding difficulty falling asleep, night wakenings and other sleep issues	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Secondary	Change in Generalized anxiety disorder--7 item (GAD7), 7-item 0-3 likert, higher scores indicate more severe symptoms	Self-report questionnaire regarding anxiety symptoms (7-item)	Trajectory over 6 weeks (baseline, 3 weeks, 6 weeks)
Secondary	Study Satisfaction Questionnaire	8 item survey regarding satisfaction with study, 0-3 likert, higher scores indicate greater satisfaction	6 weeks