Physiological Post-Concussion DisorderNCT03367507
Sub-maximal Exercise Prescription in Adolescents With Physiological Post-concussion Disorder
A study testing Sub-symptom aerobic exercise in people with Physiological Post-Concussion Disorder and Post-Concussion Syndrome, run by Sport Injury Prevention Research Centre at 2 sites in Canada.
Trial summary
Although the vast majority of individuals sustaining a sport-related concussion (SRC) will receive medical clearance to return to sport within 7-10 days, approximately 30% of children and adolescents reporting to the emergency department will experience symptoms that last longer than a month. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Physiological Post-Concussion Disorder, Post-Concussion Syndrome, Traumatic Brain Injury
- What is being tested?
- Sub-symptom aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Dec 2017to Nov 2019
- 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
- Age 13-19 years
- Physician diagnosed sports-related concussion, defined according to the 5th International Consensus Statement on Concussion in Sport (McCrory et al., 2017) as an injury caused by transmission of biomechanical forces to the brain leading to clinical symptoms affecting multiple domains of physical, cognitive, sleep, and neurobehavioral functioning (McCrory et al., 2017);
- persistent symptoms at 10-30 days post-concussion;
- a post-concussion symptom scale score greater than 5 for males and 8 for females (these are above the typically reported values for non-concussed athletes);
- self reported difficulties with exertion and/or a graded aerobic treadmill test demonstrating isolated Physiological Post Concussion Disorder;
- participant and parent/guardian informed consent;
- Participant must be able to reach a heart rate greater than 100 but less than 210 bpm, during and throughout the onset of exercise (to ensure their sub-symptom threshold is still above resting norms);
- Voluntary consent to wear an Actigraph (wGT3X-BT) accelerometer monitor for a minimum of 2 weeks and the provided Polar HR monitor during daily exercise.
Who cannot join
- clinical evidence of vestibulo-ocular dysfunction (Ellis, et al., 2015; 2017);
- clinical evidence of cervical spine soft tissue injury (Schneider et al., 2014);
- past medical history of International Classification of Diseases-3 beta version migraine headaches;
- undergoing active medical treatment for a psychiatric disorder (e.g. on medication for depression);
- contraindication to exercise testing (traumatic abnormality on neuroimaging studies, co-existing cardiac, respiratory or orthopedic contraindication to exercise testing, pregnancy);
- exercise intolerance reached before 100 bpm, or after 210 bpm (age predicted maximum heart rate) on graded exercise test;
- subjects refusal to wear Actigraph and Polar HR monitor;
- subjects resting HR above 99bpm or blood pressure greater than 144/94.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta
Kathryn J Schneider, PhD, DSc, 403 210 8951, kjschnei@ucalgary.ca
Shane Virani, MSc, shane.virani1@ucalgary.ca
Pan Am Sports Medicine Clinic
Winnipeg, Manitoba
Kelly Russell, PhD, 204-480-1312, KRussell@chrim.ca
Michael Ellis, 204-927-2766, mellis3@panamclinic.com
About this study
Official title: The Effect of Individually Tailored Sub-maximal Exercise Prescription in Adolescent Physiological Post-concussion Disorder: a Multi-institutional Randomized Controlled Trial
Although the vast majority of individuals sustaining a sport-related concussion (SRC) will receive medical clearance to return to sport within 7-10 days, approximately 30% of children and adolescents reporting to the emergency department will experience symptoms that last longer than a month. Research has demonstrated that exercise below the threshold that results in increases in symptoms, beyond those experienced at rest, (sub-symptom threshold aerobic exercise) may be beneficial in recovery. However, the optimal amount and intensity of aerobic exercise for an individual to experience the most beneficial outcomes is currently unknown. Unfortunately there are limited Randomized Controlled Trials (RCT's) evaluating the benefits of aerobic exercise in a youth population. The current evidence includes studies with relatively small sample sizes, unreliable measurements of physical activity (self-report), and inherent biases through inadequate blinding. There is a need to develop and validate evidence-informed interventions as a means of treatment for limiting time loss from sport, and school in adolescents who experience persistent symptoms of sports related concussion beyond 10 days.
Read the detailed description
Research statement:This study is a multi-centre RCT. The purpose of the RCT is to evaluate the efficacy of a moderate intensity (80% symptom threshold heart rate (HR), Borg Rating of Perceived exertion (RPE) 12-16) sub-symptom aerobic exercise prescription compared to a conservative low level aerobic exercise group (60% HR, Borg RPE 7-11) on time to medical clearance to return to play in adolescents (aged 13-19) with suggested physiological Post-Concussion Disorder (P-PCD).
Secondary objectives are to 1) Measure the adherence patterns of youth who are prescribed a specific aerobic home exercise programs. 2) Monitor longitudinal symptom reduction on the Sport Concussion Assessment Tool 5 (SCAT5) (week 0 and medical clearance) 3) Track longitudinal changes in patient-reported outcomes (symptoms) through the use of the Pediatric Quality of Life (PedsQL) questionnaire. 4) Evaluate the association between cognitive activity and time to receive medical clearance to return to sport.
Methods: A multisite RCT will be conducted at the Pan Am Concussion Program, Winnipeg, Manitoba and the Sport Injury Prevention Research Centre/Acute Sport Concussion Clinic, Sport Medicine Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta. Adolescents (n=136, 68 from each study site, ages 13-19 years) who are diagnosed with a sport-related concussion and have ongoing symptoms for more than 10 days but less than 30 days will be recruited for study participation. Participants will be randomized via permuted block to either a moderate intensity (80%) or a low intensity (60%) aerobic exercise intervention. Both groups will be instructed to perform their respective home aerobic exercise program the beginning the day after completing their first treadmill test. Participants will be instructed to exercise at their prescribed intensity for a maximum of 30 minutes a day, 4-5 days a week. In the unlikely event in which participants feel unable to continue their home exercise program they will be asked to postpone the exercise until the next day. Participants will undergo diagnostic treadmill tests every two weeks, which will be used to determine increases in exercise tolerance and serve as a parameter of physiological recovery. The treadmill tests will also be used to set a new threshold heart rate for a person to continue to exercise at for the following two weeks or until receiving medical clearance to initiate the return to play protocol. The treadmill test is made to represent the most similar form of exercise to mimic an adolescent's respective sport.
Participants will also be asked to fill out the SCAT5 symptom scores before and after treadmill testing along with the PedsQl questionnaire. Self-reported physical and cognitive activity will be tracked with daily exercise logs, these will be used in conjunction with Actigraph accelerometers and heart rate monitors which will serve as objective tools to track the quantification of physical activity.
Data safety and monitoring: The study team at the University of Manitoba have performed over 200 treadmill tests in a pediatric concussed population with no challenges regarding safety or tolerability. The study staff will be qualified to perform exercise stress tests in a safe manner based on standards of practice imposed by the University of Calgary and Canadian Society for Exercise Physiology. All study practices will be conducted under the supervision of a physician and exercise physiologist who are trained at a minimum level of cardio pulmonary resuscitation (CPR) level C and trained to use an automated external defibrillator (AED). All study personnel will know the location and how to use the on-site AED's. Monthly teleconferences will be held between the research team at the University of Manitoba and University of Calgary regarding, safety, logistics and proper manners in which to conduct exercise tests. Between both sites we will establish a data safety and monitoring committee to ensure the safety of all patients. This independent group of experts will monitor patient safety and treatment efficacy during the ongoing RCT and report their findings to the primary investigators. The committee's role will be to periodically review and evaluate the data collected thus far for any concerns related to patient safety or study conduct. If needed, they will also provide recommendations about the continuation, modification, or termination of the RCT.
- Conditions
- Physiological Post-Concussion Disorder, Post-Concussion Syndrome, Traumatic Brain Injury, Rehabilitation, Aerobic Exercise, Concussion, Brain
- Being tested
- Sub-symptom aerobic exercise
- Medical subject headings
- Post-Concussion Syndrome, Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-symptom aerobic exerciseBehavioural
Both groups will be instructed to perform their respective aerobic exercise program the following day after completing their first treadmill test. Participants will be instructed to exercise at their prescribed intensity for a maximum of 30 minutes a day, 4-5 days a week. They will be asked to postpone the exercise until the next day if they experience significant increases in symptoms from usual resting levels. Exercise type will be the participant's choice, however we will ask the participant refrain from contact/high risk activities including any modalities that might induce rapid and aggressive head movements.
| Study group | Role | What they receive |
|---|---|---|
| 80% Sub-symptom threshold aerobic exercise | Experimental | The moderate intensity intervention group will exercise at 80% of the maximum symptom free heart rate identified by their most recent graded treadmill test. The target heart rate zone will be within of the heart rate at which they experienced an increase in symptoms. The participants will be instructed to follow a program of moderate intensity activity in the form of their choice, we will recommend the following: stationary cycling, brisk walking, light jogging or the use of any available cardiovascular exercise equipment where they can control and monitor their heart rate wearing both the Actigraph and Polar HR monitor provided. Receives: Behavioral: Sub-symptom aerobic exercise |
| 60% Sub-symptom aerobic exercise | Active comparator | The light (conservative) intensity intervention group will exercise at 60% of the maximum symptom free heart rate identified by their most recent graded treadmill test. The target heart rate zone will be within of the heart rate at which they experienced an increase in symptoms. The low intensity group will perform their exercise program at their own discrepancy however we will advise either of the following activities: light walking, stationary cycling or the use of any available cardiovascular exercise equipment where they can control and monitor their heart rate while simultaneously wearing both the Actigraph and polar HR monitor. Receives: Behavioral: Sub-symptom aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to receive medical clearance to return to sport
The time it takes in days for the physician to provide clearance to the participant to return to sport (calculated from date of initiation of intervention)
Measured: up to 8 weeks
Secondary outcomes (7)
Pediatric Quality Of Life score (PedsQL)
Longitudinal changes in score on the PedsQL questionnaire (Teen;13-19, parent)
Measured: Assessed every two weeks from weeks 0 to 8 (or at time of medical clearance if prior to 8 weeks).
Sport Concussion Assessment tool 5 (symptom scores)
Longitudinal changes in symptom scores on the SCAT5 questionnaire ( Teen;13-19, parent)
Measured: Assessed weekly from weeks 0 and 8 (or time of medical clearance to return to sport if prior to 8 weeks)
Adherence to prescribed exercise
Self reported adherence patterns to youth prescribed home exercise programs
Measured: Assessed weekly from weeks 0 and 8 (or time of medical clearance if prior to 8 weeks).
Activity (kcal/day)
Amount of exercise induced (kcal/day) measured using an Actigraph)
Measured: 0-8 weeks (or time of medical clearance if prior to 8 weeks)
Symptom scores on the Sport Concussion Assessment Tool 5 (SCAT5)
The participants will rate their concussion symptoms using the SCAT5 symptom scale before and after every treadmill test to identify clinical symptom characteristics associated with physical exertion (0-132/132 where 0 indicates no symptoms)
Measured: 0-8 weeks (or time of medical clearance if prior to 8 weeks)
Cognitive activity
Cognitive activity as measured by the "Cognitive Activity Scale" (0-4/4)
Measured: Up to 8 weeks
Incidence of Migraines and Headaches
Evaluating the incidence of post-injury International Classification of Headache Disorders (ICHD-3) beta defined migraine headaches and psychiatric outcomes in each treatment group.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start10 Dec 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological Post-Concussion DisorderStudies 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
- Model description
- Research statement:This study is a multi-centre RCT. The purpose of the RCT is to evaluate the efficacy of a moderate intensity (80% symptom threshold HR, Borg RPE 12-16) sub-symptom aerobic exercise prescription compared to a lower level aerobic exercise group (60% HR, Borg RPE 7-11) on time to medical clearance to receive medical clearance to return to play in adolescents (aged 13-19) with suggested physiological Post-Concussion Disorder (P-PCD).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sport Injury Prevention Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Kathryn Schneider, PT, PhD, Principal investigator, Sport Injury Prevention Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367507
- Sponsor's protocol ID
- REB17-0570
- Status last verified
- Dec 2017
- First submitted
- 16 Nov 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Individually Tailored Sub-maximal Exercise Prescription in Adolescent Physiological Post-concussion Disorder: a Multi-institutional Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03367507
- Acronym / sponsor ID
- REB17-0570
- Conditions
- Physiological Post-Concussion Disorder, Post-Concussion Syndrome, Traumatic Brain Injury, Rehabilitation, Aerobic Exercise, Concussion, Brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Sport Injury Prevention Research CentreUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- 10 Dec 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 8 Dec 2017 (actual)
- 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.
Although the vast majority of individuals sustaining a sport-related concussion (SRC) will receive medical clearance to return to sport within 7-10 days, approximately 30% of children and adolescents reporting to the emergency department will experience symptoms that last longer than a month. Research has demonstrated that exercise below the threshold that results in increases in symptoms, beyond those experienced at rest, (sub-symptom threshold aerobic exercise) may be beneficial in recovery. However, the optimal amount and intensity of aerobic exercise for an individual to experience the most beneficial outcomes is currently unknown. Unfortunately there are limited Randomized Controlled Trials (RCT's) evaluating the benefits of aerobic exercise in a youth population. The current evidence includes studies with relatively small sample sizes, unreliable measurements of physical activity (self-report), and inherent biases through inadequate blinding. There is a need to develop and validate evidence-informed interventions as a means of treatment for limiting time loss from sport, and school in adolescents who experience persistent symptoms of sports related concussion beyond 10 days.
Detailed description
Research statement:This study is a multi-centre RCT. The purpose of the RCT is to evaluate the efficacy of a moderate intensity (80% symptom threshold heart rate (HR), Borg Rating of Perceived exertion (RPE) 12-16) sub-symptom aerobic exercise prescription compared to a conservative low level aerobic exercise group (60% HR, Borg RPE 7-11) on time to medical clearance to return to play in adolescents (aged 13-19) with suggested physiological Post-Concussion Disorder (P-PCD).
Secondary objectives are to 1) Measure the adherence patterns of youth who are prescribed a specific aerobic home exercise programs. 2) Monitor longitudinal symptom reduction on the Sport Concussion Assessment Tool 5 (SCAT5) (week 0 and medical clearance) 3) Track longitudinal changes in patient-reported outcomes (symptoms) through the use of the Pediatric Quality of Life (PedsQL) questionnaire. 4) Evaluate the association between cognitive activity and time to receive medical clearance to return to sport.
Methods: A multisite RCT will be conducted at the Pan Am Concussion Program, Winnipeg, Manitoba and the Sport Injury Prevention Research Centre/Acute Sport Concussion Clinic, Sport Medicine Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta. Adolescents (n=136, 68 from each study site, ages 13-19 years) who are diagnosed with a sport-related concussion and have ongoing symptoms for more than 10 days but less than 30 days will be recruited for study participation. Participants will be randomized via permuted block to either a moderate intensity (80%) or a low intensity (60%) aerobic exercise intervention. Both groups will be instructed to perform their respective home aerobic exercise program the beginning the day after completing their first treadmill test. Participants will be instructed to exercise at their prescribed intensity for a maximum of 30 minutes a day, 4-5 days a week. In the unlikely event in which participants feel unable to continue their home exercise program they will be asked to postpone the exercise until the next day. Participants will undergo diagnostic treadmill tests every two weeks, which will be used to determine increases in exercise tolerance and serve as a parameter of physiological recovery. The treadmill tests will also be used to set a new threshold heart rate for a person to continue to exercise at for the following two weeks or until receiving medical clearance to initiate the return to play protocol. The treadmill test is made to represent the most similar form of exercise to mimic an adolescent's respective sport.
Participants will also be asked to fill out the SCAT5 symptom scores before and after treadmill testing along with the PedsQl questionnaire. Self-reported physical and cognitive activity will be tracked with daily exercise logs, these will be used in conjunction with Actigraph accelerometers and heart rate monitors which will serve as objective tools to track the quantification of physical activity.
Data safety and monitoring: The study team at the University of Manitoba have performed over 200 treadmill tests in a pediatric concussed population with no challenges regarding safety or tolerability. The study staff will be qualified to perform exercise stress tests in a safe manner based on standards of practice imposed by the University of Calgary and Canadian Society for Exercise Physiology. All study practices will be conducted under the supervision of a physician and exercise physiologist who are trained at a minimum level of cardio pulmonary resuscitation (CPR) level C and trained to use an automated external defibrillator (AED). All study personnel will know the location and how to use the on-site AED's. Monthly teleconferences will be held between the research team at the University of Manitoba and University of Calgary regarding, safety, logistics and proper manners in which to conduct exercise tests. Between both sites we will establish a data safety and monitoring committee to ensure the safety of all patients. This independent group of experts will monitor patient safety and treatment efficacy during the ongoing RCT and report their findings to the primary investigators. The committee's role will be to periodically review and evaluate the data collected thus far for any concerns related to patient safety or study conduct. If needed, they will also provide recommendations about the continuation, modification, or termination of the RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Research statement:This study is a multi-centre RCT. The purpose of the RCT is to evaluate the efficacy of a moderate intensity (80% symptom threshold HR, Borg RPE 12-16) sub-symptom aerobic exercise prescription compared to a lower level aerobic exercise group (60% HR, Borg RPE 7-11) on time to medical clearance to receive medical clearance to return to play in adolescents (aged 13-19) with suggested physiological Post-Concussion Disorder (P-PCD).
| Arm | Type | Receives |
|---|---|---|
| 80% Sub-symptom threshold aerobic exercise | Experimental | Behavioral: Sub-symptom aerobic exerciseThe moderate intensity intervention group will exercise at 80% of the maximum symptom free heart rate identified by their most recent graded treadmill test. The target heart rate zone will be within of the heart rate at which they experienced an increase in symptoms. The participants will be instructed to follow a program of moderate intensity activity in the form of their choice, we will recommend the following: stationary cycling, brisk walking, light jogging or the use of any available cardiovascular exercise equipment where they can control and monitor their heart rate wearing both the Actigraph and Polar HR monitor provided. |
| 60% Sub-symptom aerobic exercise | Active comparator | Behavioral: Sub-symptom aerobic exerciseThe light (conservative) intensity intervention group will exercise at 60% of the maximum symptom free heart rate identified by their most recent graded treadmill test. The target heart rate zone will be within of the heart rate at which they experienced an increase in symptoms. The low intensity group will perform their exercise program at their own discrepancy however we will advise either of the following activities: light walking, stationary cycling or the use of any available cardiovascular exercise equipment where they can control and monitor their heart rate while simultaneously wearing both the Actigraph and polar HR monitor. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Age 13-19 years
- Physician diagnosed sports-related concussion, defined according to the 5th International Consensus Statement on Concussion in Sport (McCrory et al., 2017) as an injury caused by transmission of biomechanical forces to the brain leading to clinical symptoms affecting multiple domains of physical, cognitive, sleep, and neurobehavioral functioning (McCrory et al., 2017);
- persistent symptoms at 10-30 days post-concussion;
- a post-concussion symptom scale score greater than 5 for males and 8 for females (these are above the typically reported values for non-concussed athletes);
- self reported difficulties with exertion and/or a graded aerobic treadmill test demonstrating isolated Physiological Post Concussion Disorder;
Key exclusion criteria (8 listed)
- clinical evidence of vestibulo-ocular dysfunction (Ellis, et al., 2015; 2017);
- clinical evidence of cervical spine soft tissue injury (Schneider et al., 2014);
- past medical history of International Classification of Diseases-3 beta version migraine headaches;
- undergoing active medical treatment for a psychiatric disorder (e.g. on medication for depression);
- contraindication to exercise testing (traumatic abnormality on neuroimaging studies, co-existing cardiac, respiratory or orthopedic contraindication to exercise testing, pregnancy);
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-symptom aerobic exerciseBoth groups will be instructed to perform their respective aerobic exercise program the following day after completing their first treadmill test. Participants will be instructed to exercise at their prescribed intensity for a maximum of 30 minutes a day, 4-5 days a week. They will be asked to postpone the exercise until the next day if they experience significant increases in symptoms from usual resting levels. Exercise type will be the participant's choice, however we will ask the participant refrain from contact/high risk activities including any modalities that might induce rapid and aggressive head movements. | Behavioural | 60% Sub-symptom aerobic exercise, 80% Sub-symptom threshold aerobic exercise |
Primary outcome
Days to receive medical clearance to return to sport
Time frame: up to 8 weeks
The time it takes in days for the physician to provide clearance to the participant to return to sport (calculated from date of initiation of intervention)
7 secondary outcomes
Pediatric Quality Of Life score (PedsQL)
Time frame: Assessed every two weeks from weeks 0 to 8 (or at time of medical clearance if prior to 8 weeks).
Sport Concussion Assessment tool 5 (symptom scores)
Time frame: Assessed weekly from weeks 0 and 8 (or time of medical clearance to return to sport if prior to 8 weeks)
Adherence to prescribed exercise
Time frame: Assessed weekly from weeks 0 and 8 (or time of medical clearance if prior to 8 weeks).
Activity (kcal/day)
Time frame: 0-8 weeks (or time of medical clearance if prior to 8 weeks)
Symptom scores on the Sport Concussion Assessment Tool 5 (SCAT5)
Time frame: 0-8 weeks (or time of medical clearance if prior to 8 weeks)
Cognitive activity
Time frame: Up to 8 weeks
Incidence of Migraines and Headaches
Time frame: Up to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Physiological Post-Concussion Disorder
Active, not recruiting
Post-Concussion Differences Between Buffalo Concussion Treadmill Test (BCTT) and Modified Dynamic Exertion (mEXiT) Test
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.
Kathryn Schneider, PT, PhD principal investigator
Sport Injury Prevention Research Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-symptom aerobic exercise in people with Physiological Post-Concussion Disorder and Post-Concussion Syndrome, run by Sport Injury Prevention Research Centre at 2 sites 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 8 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: status not confirmed, as of the sponsor's last update on 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn J Schneider, PT, PhD (4032108951, kjschnei@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days to receive medical clearance to return to sport (time frame: up to 8 weeks). 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 8 Dec 2017.