Concussion, MildNCT03170856
The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
A study testing Sub-maximal exercise in people with Concussion, Mild and Concussion, Brain, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Concussion, Mild, Concussion, Brain, Concussion, Severe
- What is being tested?
- Sub-maximal exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment
- Low or moderate cardiac risk according to American College of Sports Medicine
- Post-Concussion Symptom Scale (PCSS) score greater than 9
Who cannot join
- History of neurological surgery
- Seizure disorder
- Use of medication or medical device that would alter heart rate, blood pressure or autonomic function
- Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity
- Unable or unwilling to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Cambridge, Massachusetts, 02138
About this study
Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.
Read the detailed description
There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.
- Being tested
- Sub-maximal exercise
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-maximal exerciseOther
Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention Group | Experimental | Thse patients will undergo a sub-maximal exercise training as treatment for concussion. Receives: Other: Sub-maximal exercise |
| Usual Care Group | No intervention | These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.
Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer.
Measured: Measured at initial visit and 8-weeks.
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.
Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem).
Measured: The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.
Secondary outcomes (4)
End-tidal CO2
Will be monitored using infrared analyzer during sub-maximal exercise testing at baseline and 8-week post injury visits.
Measured: Measured at initial visit and 8-week post injury visit.
Heart Rate
Monitored via standard 3 lead ECG during sub-maximal exercise testing at initial and 8-week visits.
Measured: Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.
Volume of Self-reported Exercise Per Week
Volume exercise was monitored by self-reported exercise diary. All participants were asked to track their exercise and complete weekly exercise logs for the 8-week study duration. The participants randomized into the Exercise Intervention Group were prescribed a specific heart rate to exercise 5x/week for 8-weeks. Heart rate was determined by their performance from the corresponding exercise testing visit. Participants enrolled in the Usual Care Group were not prescribed any specific exercise. These participants were instructed to follow their Doctors requests. Values are presented as average minutes of exercise throughout the 8-week study period.
Measured: Average volume of exercise (min) that was self-reported by participants over the 8-week study period.
Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.
Using the Borg Scale. The Borg scale is a way of measuring physical intensity level. The scale ranges from 6- no exertion at all, to 20- maximal exertion. The higher the RPE reported, the harder the participant perceives themselves to be physically working.
Measured: Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Oct 2018
- Primary completion20 Jul 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Model description
- Patients will be randomly assigned to either the exercise intervention group or the usual care group.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, William Meehan III, Boston Children's Hospital
- Investigators
- William Meehan, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170856
- Sponsor's protocol ID
- P00024907
- Status last verified
- May 2022
- First submitted
- 25 May 2017
- Last updated
- 31 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Howell DR, Taylor JA, Tan CO, Orr R, Meehan WP 3rd. The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Med Sci Sports Exerc. 2019 Apr;51(4):647-652. doi: 10.1249/MSS.0000000000001829.
PubMed 30376513Howell DR, Lugade V, Taksir M, Meehan WP 3rd. Determining the utility of a smartphone-based gait evaluation for possible use in concussion management. Phys Sportsmed. 2020 Feb;48(1):75-80. doi: 10.1080/00913847.2019.1632155. Epub 2019 Jun 26.
PubMed 31198074Howell DR, Brilliant AN, Oldham JR, Berkstresser B, Wang F, Meehan WP 3rd. Exercise in the first week following concussion among collegiate athletes: Preliminary findings. J Sci Med Sport. 2020 Feb;23(2):112-117. doi: 10.1016/j.jsams.2019.08.294. Epub 2019 Sep 7.
PubMed 31522997Howell DR, Oldham J, Lanois C, Koerte I, Lin AP, Berkstresser B, Wang F, Meehan WP 3rd. Dual-Task Gait Recovery after Concussion among Female and Male Collegiate Athletes. Med Sci Sports Exerc. 2020 May;52(5):1015-1021. doi: 10.1249/MSS.0000000000002225.
PubMed 31985574Howell DR, Brilliant AN, Meehan WP 3rd. Tandem Gait Test-Retest Reliability Among Healthy Child and Adolescent Athletes. J Athl Train. 2019 Dec;54(12):1254-1259. doi: 10.4085/1062-6050-525-18. Epub 2019 Oct 28.
PubMed 31657636Howell DR, Hunt DL, Oldham JR, Aaron SE, Meehan WP 3rd, Tan CO. Postconcussion Exercise Volume Associations With Depression, Anxiety, and Dizziness Symptoms, and Postural Stability: Preliminary Findings. J Head Trauma Rehabil. 2022 Jul-Aug 01;37(4):249-257. doi: 10.1097/HTR.0000000000000718. Epub 2021 Jul 26.
PubMed 34320557
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Sub-maximal Exercise Program on Adolescents Who Sustained a Concussion
- ClinicalTrials.gov ID
- NCT03170856
- Acronym / sponsor ID
- P00024907
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 20 Jul 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Posted 31 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who sustain a concussion will undergo a sub-maximal exercise protocol throughout their recovery. Cerebrovascular function, heart rate, and symptom severity, and exercise volume will be monitored throughout.
Detailed description
There has been recent change to the management of concussion, including the addition of exercise while a patient may still be experiencing symptoms. Some patients will be given a dose-dependent exercise prescription based on their own sub-maximal output. They will aerobically exercise at this given threshold for 8 weeks, while heart rate and symptom duration is tracked. Some patients will only follow physician prescribed exercise, while undergoing the same heart rate and symptom monitoring for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomly assigned to either the exercise intervention group or the usual care group.
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group | Experimental | Other: Sub-maximal exerciseThse patients will undergo a sub-maximal exercise training as treatment for concussion. |
| Usual Care Group | No intervention | –These patients will not undergo a sub-maximal exercise training. They will follow the exercise instructions given to them by their physician. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Experienced a concussion within the last 2 weeks. Concussion will be diagnosed by board-certified sports medicine physicians, and defined as a direct or indirect blow to the head, face, neck, or elsewhere that manifests with the presence of symptoms and neurological impairment
- Low or moderate cardiac risk according to American College of Sports Medicine
- Post-Concussion Symptom Scale (PCSS) score greater than 9
Key exclusion criteria (5 listed)
- History of neurological surgery
- Seizure disorder
- Use of medication or medical device that would alter heart rate, blood pressure or autonomic function
- Any current, serious, chronic medical or psychiatric disease that, in the Principal Investigator's judgment, may interfere with study participation or data integrity
- Unable or unwilling to provide informed consent
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 |
|---|---|---|
| Sub-maximal exerciseSubjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate. | Other | Exercise Intervention Group |
Primary outcome
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits.
Time frame: Measured at initial visit and 8-weeks.
Cerebral vasoreactivity was determined by assessing cerebrovascular conductance response to incremental hypercapnia elicited by rebreathing. Participants were fitted with a mouthpiece attached to a three-way respiratory valve unit, which, in turn, was attached to a 5-L rubber rebreathing bag. The valve allowed for an instantaneous switch from room air to the rebreathing bag, which had been prefilled with room air. EtCO2 was measured continuously via a sample line connecting the mouthpiece to an infrared CO2 analyzer.
Change in Concussion Symptoms From Baseline, 4-weeks, and 8-weeks Post-injury, During an Exercise Intervention.
Time frame: The PSCI symptom severity be a repeated measured at the time of injury, 4 weeks post-injury and 8 weeks post-injury, to look for a change in symptom score over the duration of the study.
Symptoms measured by the Post-concussion Symptom Inventory (PSCI). The PCSI ranges from 0-150 for symptom severity. The greater the number of symptoms reported, the more symptomatic the participant is. The forms focus on symptoms in the cognitive, emotional, sleep, and physical domains. There are 25 possible symptoms total. Participants answer on a scale of 0-6 for symptom severity (0- not a problem, 3- moderate problem, 6- severe problem).
4 secondary outcomes
End-tidal CO2
Time frame: Measured at initial visit and 8-week post injury visit.
Heart Rate
Time frame: Measured at initial visit and 8 weeks to look for a change as a person becomes asymptomatic.
Volume of Self-reported Exercise Per Week
Time frame: Average volume of exercise (min) that was self-reported by participants over the 8-week study period.
Rate of Perceived Exhaustion at Baseline, 4-week, and 8-week Visits.
Time frame: Measured at initial visit, 4 weeks and 8 weeks to look for a change in perceived exhaustion as a person becomes asymptomatic
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30376513Howell DR, Taylor JA, Tan CO, Orr R, Meehan WP 3rd. The Role of Aerobic Exercise in Reducing Persistent Sport-related Concussion Symptoms. Med Sci Sports Exerc. 2019 Apr;51(4):647-652. doi: 10.1249/MSS.0000000000001829.
- Background: PubMed 31198074Howell DR, Lugade V, Taksir M, Meehan WP 3rd. Determining the utility of a smartphone-based gait evaluation for possible use in concussion management. Phys Sportsmed. 2020 Feb;48(1):75-80. doi: 10.1080/00913847.2019.1632155. Epub 2019 Jun 26.
- Background: PubMed 31522997Howell DR, Brilliant AN, Oldham JR, Berkstresser B, Wang F, Meehan WP 3rd. Exercise in the first week following concussion among collegiate athletes: Preliminary findings. J Sci Med Sport. 2020 Feb;23(2):112-117. doi: 10.1016/j.jsams.2019.08.294. Epub 2019 Sep 7.
- Background: PubMed 31985574Howell DR, Oldham J, Lanois C, Koerte I, Lin AP, Berkstresser B, Wang F, Meehan WP 3rd. Dual-Task Gait Recovery after Concussion among Female and Male Collegiate Athletes. Med Sci Sports Exerc. 2020 May;52(5):1015-1021. doi: 10.1249/MSS.0000000000002225.
- Background: PubMed 31657636Howell DR, Brilliant AN, Meehan WP 3rd. Tandem Gait Test-Retest Reliability Among Healthy Child and Adolescent Athletes. J Athl Train. 2019 Dec;54(12):1254-1259. doi: 10.4085/1062-6050-525-18. Epub 2019 Oct 28.
- Derived from this study: PubMed 34320557Howell DR, Hunt DL, Oldham JR, Aaron SE, Meehan WP 3rd, Tan CO. Postconcussion Exercise Volume Associations With Depression, Anxiety, and Dizziness Symptoms, and Postural Stability: Preliminary Findings. J Head Trauma Rehabil. 2022 Jul-Aug 01;37(4):249-257. doi: 10.1097/HTR.0000000000000718. Epub 2021 Jul 26.
- Individual participant dataSharing planned: No
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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.
William Meehan, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-maximal exercise in people with Concussion, Mild and Concussion, Brain, run by Boston 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 5 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 31 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Vasoreactivity During Exercise at Baseline and 8-week Visits. (time frame: Measured at initial visit and 8-weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03170856, which also lists 6 linked publications.
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 31 Jan 2023.