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

NCT03367507 | Unknown DMC

• 1 other identifier: REB17-0570
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

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.

Conditions

Physiological Post-Concussion Disorder; Post-Concussion Syndrome; Traumatic Brain Injury; Rehabilitation; Aerobic Exercise; Concussion, Brain

Outcome Measures

Primary Outcomes (1)

• 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)

  up to 8 weeks

Secondary Outcomes (7)

• Pediatric Quality Of Life score (PedsQL)

  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)

  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

  Assessed weekly from weeks 0 and 8 (or time of medical clearance if prior to 8 weeks).

• Activity (kcal/day)

  0-8 weeks (or time of medical clearance if prior to 8 weeks)

• Symptom scores on the Sport Concussion Assessment Tool 5 (SCAT5)

  0-8 weeks (or time of medical clearance if prior to 8 weeks)

Study Arms (2)

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.

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.

Behavioral: Sub-symptom aerobic exercise

Interventions

Sub-symptom aerobic exercise BEHAVIORAL

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.

60% Sub-symptom aerobic exercise; 80% Sub-symptom threshold aerobic exercise

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sport Injury Prevention Research Centre: lead
• University of Manitoba: collaborator

Study Sites (2)

University of Calgary

Calgary, Alberta, Canada

Location

Pan Am Sports Medicine Clinic

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Kathryn Schneider, PT, PhD

  Sport Injury Prevention Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn J Schneider, PT, PhD

CONTACT

4032108951; kjschnei@ucalgary.ca

Carolyn Emery, PT, PhD

CONTACT

403-220-4608; caemery@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: December 8, 2017
• Study Start: December 10, 2017
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)