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Sub-maximal Exercise Prescription in Adolescents With Physiological Post-concussion Disorder

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ClinicalTrials.gov Identifier: NCT03367507
Recruitment Status : Not yet recruiting
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Collaborator:
University of Manitoba
Information provided by (Responsible Party):
Sport Injury Prevention Research Centre

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Physiological Post-Concussion Disorder Post-Concussion Syndrome Traumatic Brain Injury Rehabilitation Aerobic Exercise Concussion, Brain Behavioral: Sub-symptom aerobic exercise Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: Participants will not be blinded to group assignment, as it would be impossible to make them unaware of how intense their exercise prescription should be but they will be blinded to the other treatment assignment and masked to the study hypothesis. The treating sport medicine physician will be blinded to group assignment. There will be an exercise physiologist who will be responsible for conducting the treadmill tests and, prescribing aerobic exercise programs. The study exercise physiologist will not be blinded and will not relay any information pertaining to group assignment to other members involved in the study other than the participants themselves and their parents. Those assessing adverse events will not be masked and if needed to facilitate clinical care the managing physician will be made aware of the treatment group. Compliance will be tracked through the use of Actigraph accelerometers, heart rate monitors and daily activity logs.
Primary Purpose: Treatment
Official Title: The Effect of Individually Tailored Sub-maximal Exercise Prescription in Adolescent Physiological Post-concussion Disorder: a Multi-institutional Randomized Controlled Trial
Estimated Study Start Date : December 10, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 80% Sub-symptom threshold aerobic exercise
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
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.

Active Comparator: 60% 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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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). ]
    Longitudinal changes in score on the PedsQL questionnaire (Teen;13-19, parent)

  2. 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) ]
    Longitudinal changes in symptom scores on the SCAT5 questionnaire ( Teen;13-19, parent)

  3. Adherence to prescribed exercise [ Time Frame: Assessed weekly from weeks 0 and 8 (or time of medical clearance if prior to 8 weeks). ]
    Self reported adherence patterns to youth prescribed home exercise programs

  4. Activity (kcal/day) [ Time Frame: 0-8 weeks (or time of medical clearance if prior to 8 weeks) ]
    Amount of exercise induced (kcal/day) measured using an Actigraph)

  5. 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) ]
    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)

  6. Cognitive activity [ Time Frame: Up to 8 weeks ]
    Cognitive activity as measured by the "Cognitive Activity Scale" (0-4/4)

  7. Incidence of Migraines and Headaches [ Time Frame: Up to 8 weeks ]
    Evaluating the incidence of post-injury International Classification of Headache Disorders (ICHD-3) beta defined migraine headaches and psychiatric outcomes in each treatment group.



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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 13-19 years
  2. 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);
  3. persistent symptoms at 10-30 days post-concussion;
  4. 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);
  5. self reported difficulties with exertion and/or a graded aerobic treadmill test demonstrating isolated Physiological Post Concussion Disorder;
  6. participant and parent/guardian informed consent;
  7. 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);
  8. 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.

Exclusion Criteria:

  1. clinical evidence of vestibulo-ocular dysfunction (Ellis, et al., 2015; 2017);
  2. clinical evidence of cervical spine soft tissue injury (Schneider et al., 2014);
  3. past medical history of International Classification of Diseases-3 beta version migraine headaches;
  4. undergoing active medical treatment for a psychiatric disorder (e.g. on medication for depression);
  5. contraindication to exercise testing (traumatic abnormality on neuroimaging studies, co-existing cardiac, respiratory or orthopedic contraindication to exercise testing, pregnancy);
  6. exercise intolerance reached before 100 bpm, or after 210 bpm (age predicted maximum heart rate) on graded exercise test;
  7. subjects refusal to wear Actigraph and Polar HR monitor;
  8. subjects resting HR above 99bpm or blood pressure greater than 144/94.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367507


Contacts
Contact: Kathryn J Schneider, PT, PhD 4032108951 kjschnei@ucalgary.ca
Contact: Carolyn Emery, PT, PhD 403-220-4608 caemery@ucalgary.ca

Locations
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada
Contact: Kathryn J Schneider, PhD, DSc    403 210 8951    kjschnei@ucalgary.ca   
Contact: Shane Virani, MSc       shane.virani1@ucalgary.ca   
Principal Investigator: Kathryn J Schneider, DSc, PhD         
Sub-Investigator: Keith O Yeates, PhD         
Principal Investigator: Carolyn A Emery, PhD         
Sub-Investigator: Brian Brooks, PhD         
Canada, Manitoba
Pan Am Sports Medicine Clinic Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Kelly Russell, PhD    204-480-1312    KRussell@chrim.ca   
Contact: Michael Ellis    204-927-2766    mellis3@panamclinic.com   
Sponsors and Collaborators
Sport Injury Prevention Research Centre
University of Manitoba
Investigators
Principal Investigator: Kathryn Schneider, PT, PhD Sport Injury Prevention Research Centre

Responsible Party: Sport Injury Prevention Research Centre
ClinicalTrials.gov Identifier: NCT03367507     History of Changes
Other Study ID Numbers: REB17-0570
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Brain Injuries
Brain Injuries, Traumatic
Post-Concussion Syndrome
Brain Concussion
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating