An interventional study of Sub-symptom aerobic exercise in Physiological Post-Concussion Disorder, Post-Concussion Syndrome and Traumatic Brain Injury, sponsored by Sport Injury Prevention Research Centre. Status unknown at 2 sites in Canada. Open to participants aged 13 Years to 19 Years. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by Sport Injury Prevention Research Centre · Not applicable, Interventional, and Treatment
Among 30 studies in Post-Concussion Syndrome with a site in Canada — 3 open to participants now, 5 under way, none of them phase 3. Post-Concussion Syndrome · Canada.
Among the 30 studies in Post-Concussion Syndrome with a site in Canada, this one is the 5th largest by planned enrollment, is one of 3 that started in 2017, is one of 26 with no phase, and was the 15th registered.
140 studies on the registry are indexed under Post-Concussion Syndrome; 33 are open to participants now.
Browse Post-Concussion Syndrome studies →3 of the 30 studies in Post-Concussion Syndrome with a site in Canada are open now. Recruiting first, the newest first:
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18–60
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18–60
Michael Zitney · Sites in Canada
Ages 18–70 · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 24 Post-Concussion Syndrome studies recruiting now, 3 (13%) set no upper age limit and 20 (83%) stop at 75 or younger; 2 take children under 18; 5 take healthy volunteers.
This study: 13 Years to 19 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
30 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 3 · Phase 3 1
First in 2004; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 136 is above the median of 52 across 113 interventional studies indexed under Post-Concussion Syndrome.
Median enrollment 40 across the 30 interventional studies. Of the 14 that completed or were terminated, 1 (7%) have results posted.
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1 of 30 have an industry lead sponsor. The 10 most frequent:
Sport Injury Prevention Research Centre is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Sport Injury Prevention Research Centre has 1 study filed under Post-Concussion Syndrome — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 30 studies in Post-Concussion Syndrome with a site in Canada, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Sub-symptom aerobic exercise
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.
Behavioral: Sub-symptom aerobic exercise
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.
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)
Time frame: up to 8 weeks
Pediatric Quality Of Life score (PedsQL)
Longitudinal changes in score on the PedsQL questionnaire (Teen;13-19, parent)
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)
Longitudinal changes in symptom scores on the SCAT5 questionnaire ( Teen;13-19, parent)
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
Self reported adherence patterns to youth prescribed home exercise programs
Time frame: 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)
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)
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)
Time frame: 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)
Time frame: 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.
Time frame: Up to 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2017; primary completion for Jun 2019, 18 months later.
Of 54 non-industry interventional studies with no phase under Post-Concussion Syndrome, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 58. This study's planned 18 months is below that.
Counting every sponsor, half of 56 studies reached it within 40 months; a quarter within 23 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Sport Injury Prevention Research Centre