Evidence map›Paper›PMID 35473570›Full record

ArticleTrials2022

Mobile Subthreshold Exercise Program (MSTEP) for concussion: study protocol for a randomized controlled trial.

Sara P D Chrisman, Beth J Bollinger, Jason A Mendoza, Tonya M Palermo, Chuan Zhou, M Alison Brooks, Frederick P Rivara

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04688255 (Randomized Controlled Trial Using Telehealth-delivered Rehabilitative Exercise to Treat Youth With Prolonged Concussion Recovery), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04688255 naactive not recruitingnot on this map

Randomized Controlled Trial Using Telehealth-delivered Rehabilitative Exercise to Treat Youth With Prolonged Concussion Recovery (Mobile Subthreshold Exercise Program, MSTEP-R01)

TypeinterventionalSponsorSeattle Children's HospitalRan2021 to 2025Enrolled200ConditionsConcussion, Brain, Concussion, Mild, Brain Injuries, Traumatic, Persistent Post Traumatic HeadacheArmsMSTEP, Stretching
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Sara P D ChrismanCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, PO Box 5371, CURE-03, Seattle, WA, 98145, USA. sara.chrisman@seattlechildrens.org.ORCID http://orcid.org/0000-0001-5373-7223
Beth J BollingerCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, PO Box 5371, CURE-03, Seattle, WA, 98145, USA.
Jason A MendozaCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, PO Box 5371, CURE-03, Seattle, WA, 98145, USA.
Tonya M PalermoCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, PO Box 5371, CURE-03, Seattle, WA, 98145, USA.
Chuan ZhouCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, PO Box 5371, CURE-03, Seattle, WA, 98145, USA.
M Alison BrooksUniversity of Wisconsin, Madison, USA.
Frederick P RivaraCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, PO Box 5371, CURE-03, Seattle, WA, 98145, USA.
Seattle Children's Hospital · USUniversity of Wisconsin–Madison · US

Funding

Mobile Subthreshold Exercise Program for Concussion (M-STEP)R01HD094722 · NICHD · SEATTLE CHILDREN'S HOSPITAL · PI CHRISMAN, SARA P.D. · 2020 to 2024
$3.2M
NICHD NIH HHS R01 HD094722
6 · The paper itself

Abstract

backgroundSubthreshold exercise, defined as aerobic exercise below the level that causes symptoms, has been utilized as a treatment for youth with persistent postconcussive symptoms (PPCS), but there is currently little evidence to guide use. In addition, prior studies of exercise for PPCS have all required multiple in-person visits. We developed a virtual approach for delivering subthreshold exercise to youth with PPCS called the Mobile Subthreshold Exercise Program (MSTEP), and we have now been funded to conduct a large national randomized controlled trial (RCT) to test its efficacy for reducing concussive symptoms and improving health-related quality of life.

methodsThis investigation is an RCT comparing MSTEP to an active control. We will recruit 200 adolescents 11-18 years old with postconcussive symptoms persisting for at least 1 week but less than 1 year. Youth will be randomized to receive either 6 weeks of subthreshold exercise (MSTEP) or a stretching condition (control). Youth and parents will complete surveys of concussive symptoms at baseline, weekly during the intervention, and at 3 and 6 months. The primary outcomes will be trajectory of concussive symptoms and health-related quality of life over the 6 months of the study. Secondary outcomes will include depression, anxiety, and sleep quality. We will also assess potential mediators of treatment effects including moderate-vigorous physical activity and fear avoidance of concussive symptoms. DISCUSSION: This multisite RCT of MSTEP will provide vital information regarding the efficacy of a virtually delivered subthreshold exercise program for youth with PPCS, and insight regarding potential mediators of treatment effects, including objectively measured physical activity and fear avoidance of concussive symptoms.

trial registrationClinicalTrials.gov NCT04688255. Registered on December 29, 2020.

Indexed as

Brain ConcussionPost-Concussion SyndromeAdolescentChildExerciseExercise TherapyHumansQuality of LifeRandomized Controlled Trials as TopicBrain concussionChildClinical trialExercisePhysical activityRandomized controlled trial

Identifiers

PMID35473570
PMCPMC9040347
OpenAlexW4224434490

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.