Persistent Concussion SymptomsSTEPNCT02673112
Study of an Exercise Program (STEP) for Youth With Concussion
A study testing Subthreshold exercise (STEP) with mobile health coaching and Light stretching (LS) in people with Persistent Concussion Symptoms, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Persistent Concussion Symptoms
- What is being tested?
- Subthreshold exercise (STEP) with mobile health coaching and Light stretching (LS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Sports-related concussion that occurred 1-6 months inclusive prior to the start of the study, and was diagnosed by a clinician trained in concussion management consistent with the Zurich definition of concussion ("a complex pathophysiological process affecting the brain, induced by biomechanical forces [that] results in a graded set of clinical symptoms that may or may not involve loss of consciousness")
- Persistent symptoms as defined by the presence of at least 2 concussive symptoms (from the Health Behavior Inventory, or HBI) at the time of recruitment which were not present prior to injury
- 11 to 18 years of age (inclusive) at time of recruitment
Who cannot join
- Non-English speaking youth or parents
- Unwilling or unable to travel to Seattle Children's Hospital or Seattle Children's Research Institute twice during the course of the study
- Cervical spine or vestibular issues requiring further targeted intervention
- Other injuries or medical conditions in addition to concussion which would preclude vigorous exercise
- Psychiatric hospitalization in the year prior to enrollment
- Significant cognitive deficits such as mental retardation or autism
- Lack of worsening of concussive symptoms with exertion
- Significant abnormalities on routine brain imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98136
About this study
To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms.
Read the detailed description
This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). The investigators are utilizing an active control (light stretching). The primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI) in the first month after randomization. Long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.
- Conditions
- Persistent Concussion Symptoms
- Being tested
- Subthreshold exercise (STEP) with mobile health coaching, Light stretching (LS)
- Keywords
- Concussion, mild traumatic brain injury, post concussion syndrome, child
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subthreshold exercise (STEP) with mobile health coachingBehavioural
Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching
Light stretching (LS)Behavioural
Brief daily stretching routine.
| Study group | Role | What they receive |
|---|---|---|
| STEP-mhc + LS | Experimental | Subjects will be asked to perform exercise at 80% of the heart rate threshold determined using the Balke protocol for 5 minutes greater than their measured minutes of MVPA/day at baseline (Subthreshold exercise program). They will also be given a light stretching protocol (5 stretches). The exercise intervention will last for 6 weeks and will be supported by weekly health coaching. Receives: Behavioral: Subthreshold exercise (STEP) with mobile health coaching; Behavioral: Light stretching (LS) |
| LS alone | Active comparator | Subjects will be given a light stretching program alone (5 stretches). The exercise program will last for 6 weeks. Receives: Behavioral: Light stretching (LS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Behavior Inventory (HBI)
Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI.
Measured: Baseline, Weekly from 1-6 weeks, 3 months, 6 months
Secondary outcomes (3)
PedsQL
Health related quality of life
Measured: Baseline, 6 weeks, 3 and 6 months
Fear of Pain Questionniare (FOPQ), child and parent
Measure of fear avoidance
Measured: Trajectory from baseline, 6 weeks, 3 months, 6 months
Moderate-vigorous physical activity (MVPA)
Hip-mounted research grade accelerometry
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionSep 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Concussion SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Chrisman, Seattle Children's Hospital
- Investigators
- Sara P Chrisman, MD MPH, Principal investigator, Seattle Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673112
- Sponsor's protocol ID
- 00000023
- Acronym
- STEP
- Status last verified
- Oct 2018
- First submitted
- 26 Jan 2016
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of an Exercise Program (STEP) for Youth With Concussion
- ClinicalTrials.gov ID
- NCT02673112
- Acronym / sponsor ID
- STEP / 00000023
- Conditions
- Persistent Concussion Symptoms
- Keywords
- Concussion, mild traumatic brain injury, post concussion syndrome, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of a sub-threshold aerobic exercise intervention provided with mobile health coaching (STEP-mhc) and a light stretching program (LS) to LS alone for 11-18 yo youth with persistent concussion symptoms.
Detailed description
This is a minimal risk randomized controlled trial whose aim is to test the efficacy of an exercise intervention (STEP) for youth 11-18 yo with persistent concussive symptoms (1-6 months inclusive). The investigators are utilizing an active control (light stretching). The primary outcome will be concussion symptoms measured with the Health-Behavior Inventory (HBI) in the first month after randomization. Long-term efficacy will be examined using standardized measures of quality of life and function over 6 months, and potential mediators will be explored including brain derived neurotrophic factor (BDNF), fear-avoidance and physical fitness. Physical activity will be measured with accelerometry to evaluate fidelity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEP-mhc + LS | Experimental | Behavioral: Subthreshold exercise (STEP) with mobile health coaching, Behavioral: Light stretching (LS)Subjects will be asked to perform exercise at 80% of the heart rate threshold determined using the Balke protocol for 5 minutes greater than their measured minutes of MVPA/day at baseline (Subthreshold exercise program). They will also be given a light stretching protocol (5 stretches). The exercise intervention will last for 6 weeks and will be supported by weekly health coaching. |
| LS alone | Active comparator | Behavioral: Light stretching (LS)Subjects will be given a light stretching program alone (5 stretches). The exercise program will last for 6 weeks. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Sports-related concussion that occurred 1-6 months inclusive prior to the start of the study, and was diagnosed by a clinician trained in concussion management consistent with the Zurich definition of concussion ("a complex pathophysiological process affecting the brain, induced by biomechanical forces [that] results in a graded set of clinical symptoms that may or may not involve loss of consciousness")
- Persistent symptoms as defined by the presence of at least 2 concussive symptoms (from the Health Behavior Inventory, or HBI) at the time of recruitment which were not present prior to injury
- 11 to 18 years of age (inclusive) at time of recruitment
Key exclusion criteria (8 listed)
- Non-English speaking youth or parents
- Unwilling or unable to travel to Seattle Children's Hospital or Seattle Children's Research Institute twice during the course of the study
- Cervical spine or vestibular issues requiring further targeted intervention
- Other injuries or medical conditions in addition to concussion which would preclude vigorous exercise
- Psychiatric hospitalization in the year prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subthreshold exercise (STEP) with mobile health coachingAerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching | Behavioural | STEP-mhc + LS |
| Light stretching (LS)Brief daily stretching routine. | Behavioural | LS alone, STEP-mhc + LS |
Primary outcome
Health Behavior Inventory (HBI)
Time frame: Baseline, Weekly from 1-6 weeks, 3 months, 6 months
Measure change in concussion symptoms from the baseline evaluation to post-intervention (6 weeks) using HBI.
3 secondary outcomes
PedsQL
Time frame: Baseline, 6 weeks, 3 and 6 months
Fear of Pain Questionniare (FOPQ), child and parent
Time frame: Trajectory from baseline, 6 weeks, 3 months, 6 months
Moderate-vigorous physical activity (MVPA)
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Persistent Concussion Symptoms
Not yet recruiting
Electroencephalography Markers of Brain Stimulation in Post-Concussion Patients
Patients With Persistent Post-concussion Symptoms
Active, not recruiting
Move&Connect: A Program for Youth With Concussion and Their Caregivers.
Post-Concussion Syndrome
RecruitingPhase 2
Hyperbaric Oxygen Therapy for Veterans With TBI and PCS: A Biomarker Study
Traumatic Brain Injury (TBI) Patients, Post Concussive Symptoms
RecruitingPhase 2/3
Randomized Controlled Trial of Treatment to Optimize Heart Rate Variability for Persistent Post-Concussion Symptoms
Autonomic Nervous System Disease, Concussive Injury
Recruiting
Targeting Neuroplasticity for Persistent Post-Concussive Cognitive Symptoms
Persistent Post Concussion Syndrome, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara P Chrisman, MD MPH principal investigator
Seattle Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subthreshold exercise (STEP) with mobile health coaching and Light stretching (LS) in people with Persistent Concussion Symptoms, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Behavior Inventory (HBI) (time frame: Baseline, Weekly from 1-6 weeks, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.