Mobile Subthreshold Exercise Program for Concussion

NCT ID: NCT03691363

Last Updated: 2021-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-06

Study Completion Date

2019-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Brain Concussion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All youth will receive the intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M-STEP

Mobile exercise intervention

Group Type EXPERIMENTAL

M-STEP

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Sub-threshold exercise

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sara PD Chrisman, MD MPH

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sara PD Chrisman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Chrisman SPD, Mendoza JA, Zhou C, Palermo TM, Gogue-Garcia T, Janz KF, Rivara FP. Pilot Study of Telehealth Delivered Rehabilitative Exercise for Youth With Concussion: The Mobile Subthreshold Exercise Program (MSTEP). Front Pediatr. 2021 May 28;9:645814. doi: 10.3389/fped.2021.645814. eCollection 2021.

Reference Type DERIVED
PMID: 34123963 (View on PubMed)

Other Identifiers

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00001039

Identifier Type: -

Identifier Source: org_study_id

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