ConcussionNCT02674620
Trial of Aerobic Treadmill Exercise Treatment for Concussion
A study testing Aerobic Exercise in people with Concussion, run by Panam Clinic at 1 site in Canada.
Trial summary
A post-concussion syndrome (PCS) diagnosis has historically led to a recommendation of continued mental and physical rest to minimize symptoms. However, this conservative approach does not consider the pathophysiological mechanisms and neurological subsystem dysfunction which mediate persistent signs and symptoms. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Concussion
- What is being tested?
- Aerobic Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2015to 8 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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Must meet the diagnostic criteria of a concussion set forth by the Consensus Statement on Concussion in Sport 4th Annual Conference of Concussion in Sport, 2013 as determined by the treating neurosurgeon.
- Presence of concussion-related symptoms at the time of testing.
- Glasgow coma scale (GCS)=15
- Patients for who parental consent can be obtained.
Who cannot join
- Patients with a history of moderate or severe traumatic brain injury, epilepsy, or stroke.
- Patients who have been diagnosed with a skull fracture, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intraparenchymal hemorrhage, or cerebral contusion on previous neuro-imaging studies.
- Pregnant female patients.
- GCS ≤ 14.
- Patients with contraindications to exercise testing as assessed by PARmed-X assessment.
- Patients for who parental consent can not be obtained.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Aerobic Treadmill Exercise Treatment for Concussion
A post-concussion syndrome (PCS) diagnosis has historically led to a recommendation of continued mental and physical rest to minimize symptoms. However, this conservative approach does not consider the pathophysiological mechanisms and neurological subsystem dysfunction which mediate persistent signs and symptoms. Recently, developing research is recommending targeted therapies for specific post-concussion disorders (physiologic, vestibulo-ocular and cervicogenic). The Buffalo Concussion Treadmill Test (BCTT) is a graded aerobic test that has emerged as safe, reliable, and effective in distinguishing between post-concussion syndrome sub-types, quantifying physiological recovery, and guiding return to play decision making. It has been proposed that the results of a BCTT can be used to prescribe progressively intensifying whole body aerobic exercise (such as walking or biking), maintained at a sub-symptom threshold, to improve autoregulatory function with the potential to improve PCS symptoms. Positive results with BCTT have now made it the standard of care at the University of Buffalo Concussion Clinic and Pan Am Clinic during the management of sport related concussions. Despite its increased use in patients with post-concussion syndrome there is currently no data on the use of exercise treatment in the early stages of concussion recovery.
Read the detailed description
This is a randomized controlled trial of sub-threshold (symptom-threshold) exercise therapy versus relative rest treatment in subjects with an acute phase concussion.
If a participant is eligible and consent has been given the neurosurgeon will conduct a Physical Activity Readiness Medical Examination (PARmed-X) and the participant will complete an exercise tolerance test on a treadmill (Visit 1) under the supervision of the neurosurgeon and exercise scientist. Using a standardized Balke protocol, participants will perform an incremental treadmill test to the point of symptom onset of exacerbation (increase of 2 points on an overall condition Likert scale). Those who achieve a peak Heart Rate (HR) > 150 bpm will be excluded from the study since they are close to full recovery. Those who achieve a HR > 120 but < 150 bpm and who cannot exercise to exhaustion (defined as a final rating of perceived exertion (RPE) < 17 on a Borg scale) will be randomly assigned to sub-threshold aerobic exercise (exercise at a HR equivalent to 80% of their HR achieved at symptom onset or exacerbation) or to relative rest. Any participant who does not achieve a HR > 120 bpm will return the following week for a repeat treadmill test (Visit 2). If they achieve a HR > 120 bpm but cannot exercise to exhaustion during Visit 2, they will be randomly assigned to sub-threshold exercise or to relative rest. This is because participants must demonstrate a level of exercise tolerance to have a reasonable sub-threshold (80% of achieved HR) exercise treatment prescription.
Participants randomized to sub-threshold aerobic exercise will be given a HR monitor and a specific HR intensity to exercise at 30 minutes per day. Participants randomized to rest will be asked to rest for 30 minutes per day (no structured physical or cognitive activity for at least 30 minutes per day and no participation in structured aerobic exercise during the entire study). After randomization, all subjects will have treadmill testing at all subsequent follow-ups with the neurosurgeon (every 1 to 2 weeks) to determine physiological recovery. All participants will be asked to document their symptom data into a form between 7-10 PM each evening (following that day's exercise for the exercise group), along with hours of work/school, and minutes of exercise.
The study end point for each subject is at recovery (as determined by a normal exercise level and an exam from the treating neurosurgeon).
Data Analysis
All statistics will be presented as mean ± SD. Data will be analyzed with a two-way analysis of variance to compare physiological variables for the exercise and rest groups over the duration of the study. Total test duration, maximum heart rate achieved and peak respiratory rate will be compared between the two groups with an independent samples t-test. A repeated measures ANOVA will be used for all questionnaire analyses. All analysis will be completed using SPSS 22 (IBM corp, Armonk, NY, USA) with an alpha level set at p<0.05.
- Conditions
- Concussion
- Being tested
- Aerobic 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.
Aerobic ExerciseOther
Patients are treated with progressive exercise
| Study group | Role | What they receive |
|---|---|---|
| Conservative | No intervention | Standard conservative care of concussion |
| Treadmill | Experimental | Aerobic exercise treatment for concussion Receives: Other: Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days from injury to full recovery
To be considered at "Full recovery", participant must meet the following criteria - Asymptomatic at rest (PCSS score under 7), participating in full school activities (as pre-injury) without symptoms, normal neurological exam, and normal vestibulo-ocular exam
Measured: From date of injury (day 0) to date of recovery of symptoms (as defined in Outcome measure) or when the patient is discharged from care, whichever came first, assessed up to 180 days post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJun 2015
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ConcussionStudies 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
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter MacDonald, Panam Clinic
- Investigators
- Jeff R Leiter, PhD, Principal investigator, Pan Am Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674620
- Sponsor's protocol ID
- B2015:020
- Status last verified
- Feb 2018
- First submitted
- 25 Jan 2016
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Leddy JJ, Baker JG, Kozlowski K, Bisson L, Willer B. Reliability of a graded exercise test for assessing recovery from concussion. Clin J Sport Med. 2011 Mar;21(2):89-94. doi: 10.1097/JSM.0b013e3181fdc721.
PubMed 21358497Leddy JJ, Kozlowski K, Fung M, Pendergast DR, Willer B. Regulatory and autoregulatory physiological dysfunction as a primary characteristic of post concussion syndrome: implications for treatment. NeuroRehabilitation. 2007;22(3):199-205.
PubMed 17917170
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Aerobic Treadmill Exercise Treatment for Concussion
- ClinicalTrials.gov ID
- NCT02674620
- Acronym / sponsor ID
- B2015:020
- Conditions
- Concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 4 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.
A post-concussion syndrome (PCS) diagnosis has historically led to a recommendation of continued mental and physical rest to minimize symptoms. However, this conservative approach does not consider the pathophysiological mechanisms and neurological subsystem dysfunction which mediate persistent signs and symptoms. Recently, developing research is recommending targeted therapies for specific post-concussion disorders (physiologic, vestibulo-ocular and cervicogenic). The Buffalo Concussion Treadmill Test (BCTT) is a graded aerobic test that has emerged as safe, reliable, and effective in distinguishing between post-concussion syndrome sub-types, quantifying physiological recovery, and guiding return to play decision making. It has been proposed that the results of a BCTT can be used to prescribe progressively intensifying whole body aerobic exercise (such as walking or biking), maintained at a sub-symptom threshold, to improve autoregulatory function with the potential to improve PCS symptoms. Positive results with BCTT have now made it the standard of care at the University of Buffalo Concussion Clinic and Pan Am Clinic during the management of sport related concussions. Despite its increased use in patients with post-concussion syndrome there is currently no data on the use of exercise treatment in the early stages of concussion recovery.
Detailed description
This is a randomized controlled trial of sub-threshold (symptom-threshold) exercise therapy versus relative rest treatment in subjects with an acute phase concussion.
If a participant is eligible and consent has been given the neurosurgeon will conduct a Physical Activity Readiness Medical Examination (PARmed-X) and the participant will complete an exercise tolerance test on a treadmill (Visit 1) under the supervision of the neurosurgeon and exercise scientist. Using a standardized Balke protocol, participants will perform an incremental treadmill test to the point of symptom onset of exacerbation (increase of 2 points on an overall condition Likert scale). Those who achieve a peak Heart Rate (HR) > 150 bpm will be excluded from the study since they are close to full recovery. Those who achieve a HR > 120 but < 150 bpm and who cannot exercise to exhaustion (defined as a final rating of perceived exertion (RPE) < 17 on a Borg scale) will be randomly assigned to sub-threshold aerobic exercise (exercise at a HR equivalent to 80% of their HR achieved at symptom onset or exacerbation) or to relative rest. Any participant who does not achieve a HR > 120 bpm will return the following week for a repeat treadmill test (Visit 2). If they achieve a HR > 120 bpm but cannot exercise to exhaustion during Visit 2, they will be randomly assigned to sub-threshold exercise or to relative rest. This is because participants must demonstrate a level of exercise tolerance to have a reasonable sub-threshold (80% of achieved HR) exercise treatment prescription.
Participants randomized to sub-threshold aerobic exercise will be given a HR monitor and a specific HR intensity to exercise at 30 minutes per day. Participants randomized to rest will be asked to rest for 30 minutes per day (no structured physical or cognitive activity for at least 30 minutes per day and no participation in structured aerobic exercise during the entire study). After randomization, all subjects will have treadmill testing at all subsequent follow-ups with the neurosurgeon (every 1 to 2 weeks) to determine physiological recovery. All participants will be asked to document their symptom data into a form between 7-10 PM each evening (following that day's exercise for the exercise group), along with hours of work/school, and minutes of exercise.
The study end point for each subject is at recovery (as determined by a normal exercise level and an exam from the treating neurosurgeon).
Data Analysis
All statistics will be presented as mean ± SD. Data will be analyzed with a two-way analysis of variance to compare physiological variables for the exercise and rest groups over the duration of the study. Total test duration, maximum heart rate achieved and peak respiratory rate will be compared between the two groups with an independent samples t-test. A repeated measures ANOVA will be used for all questionnaire analyses. All analysis will be completed using SPSS 22 (IBM corp, Armonk, NY, USA) with an alpha level set at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | No intervention | –Standard conservative care of concussion |
| Treadmill | Experimental | Other: Aerobic ExerciseAerobic exercise treatment for concussion |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Must meet the diagnostic criteria of a concussion set forth by the Consensus Statement on Concussion in Sport 4th Annual Conference of Concussion in Sport, 2013 as determined by the treating neurosurgeon.
- Presence of concussion-related symptoms at the time of testing.
- Glasgow coma scale (GCS)=15
- Patients for who parental consent can be obtained.
Key exclusion criteria (6 listed)
- Patients with a history of moderate or severe traumatic brain injury, epilepsy, or stroke.
- Patients who have been diagnosed with a skull fracture, traumatic subarachnoid hemorrhage, subdural hematoma, epidural hematoma, intraparenchymal hemorrhage, or cerebral contusion on previous neuro-imaging studies.
- Pregnant female patients.
- GCS ≤ 14.
- Patients with contraindications to exercise testing as assessed by PARmed-X assessment.
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 |
|---|---|---|
| Aerobic ExercisePatients are treated with progressive exercise | Other | Treadmill |
Primary outcome
Number of days from injury to full recovery
Time frame: From date of injury (day 0) to date of recovery of symptoms (as defined in Outcome measure) or when the patient is discharged from care, whichever came first, assessed up to 180 days post-injury
To be considered at "Full recovery", participant must meet the following criteria - Asymptomatic at rest (PCSS score under 7), participating in full school activities (as pre-injury) without symptoms, normal neurological exam, and normal vestibulo-ocular exam
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 20 Mar 2019.
- Background: PubMed 21358497Leddy JJ, Baker JG, Kozlowski K, Bisson L, Willer B. Reliability of a graded exercise test for assessing recovery from concussion. Clin J Sport Med. 2011 Mar;21(2):89-94. doi: 10.1097/JSM.0b013e3181fdc721.
- Background: PubMed 17917170Leddy JJ, Kozlowski K, Fung M, Pendergast DR, Willer B. Regulatory and autoregulatory physiological dysfunction as a primary characteristic of post concussion syndrome: implications for treatment. NeuroRehabilitation. 2007;22(3):199-205.
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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.
Jeff R Leiter, PhD principal investigator
Pan Am Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Concussion, run by Panam Clinic at 1 site in Canada.
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 4 inclusion and 6 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 20 Mar 2019. 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 Canada. 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?
Number of days from injury to full recovery (time frame: From date of injury (day 0) to date of recovery of symptoms (as defined in Outcome measure) or when the patient is discharged from care, whichever came first, assessed up to 180 days post-injury). 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 NCT02674620, which also lists 2 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 20 Mar 2019.