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Concussion GYM-T: Graded exercise in Youth to Maximise early recovery using Tele-exercise model: A Randomised Control Trial

Concussion GYM-T: Graded exercise in Youth to Maximise early recovery using Tele-exercise model: A Randomised Control Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001549718
Enrollment
100
Registered
2022-12-15
Start date
2023-04-04
Completion date
2024-10-31
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Concussion is a significant public health concern among Australian children and adolescents. A large population of children who experience a concussion (approximately 30%) will go on to experience persistence post-concussion symptoms for more than 4 weeks following their injury. These symptoms can limit their ability to attend and engage in school, extra-curricular activities and can lead to reduced quality of life. International consensus on Concussion recommends a brief period of physical rest immediately after concussion (24-48 hours) followed by a graduated return to physical activity at a level that does not provoke significant symptom exacerbation . Active rehabilitation involving sub-symptom threshold aerobic activity is a growing area of research with evidence showing reduced symptoms and improvements in recovery following concussion. The primary aim of the study is to evaluate whether a telehealth-supervised sub-symptom, graded return to aerobic exercise program improves recovery for children and adolescents who have sustained a concussion when compared to standard care. This study will be commenced once the Phase 1 - Validation of Modified Shuttle Test has been completed. We aim to see children by 3 months post-injury in the Complex Concussion Clinic: our current wait time is 3 months. While the child is waiting to be seen, PPCS limits physical activity and quality of life limiting their ability to participate in school and recreational activities. The longer symptoms persist the more difficult it is to treat these persistent symptoms and more health-related interventions are often needed to aid the child to return to normal school and sport activities. If the trial is successful, children will be able to return to these activities quicker, with a resultant decrease in the burden of the injury, and improvement in quality of life. A later cost-effectiveness of the intervention will be performed. The projected outcome of the project is to have a fully completed study protocol, with ethics approval, and a completed RCT within the specified timeline (24 months). This project is significant because not only will it impact QPRS, but the results of the study will have a far reach, Queensland wide with a more equitable service able to be provided to patients across the state. Information gained from the study could potentially lead to a change in current practice within QPRS and lead to future studies looking a how to translate this knowledge across QLD and Australia.

Interventions

A randomized controlled trial of a 4-week tele-exercise program compared to standard care to improve recovery from concussion in children and youth. The study will be conducted as a randomized controlled study to determine if the additional of supervised and graded return to aerobic exercise has an impact on the reduction in symptoms of children/adolescents following a concussion. The RCT design was chosen as it is considered to provide the most reliable evidence on the effectiveness of the in

A randomized controlled trial of a 4-week tele-exercise program compared to standard care to improve recovery from concussion in children and youth. The study will be conducted as a randomized controlled study to determine if the additional of supervised and graded return to aerobic exercise has an impact on the reduction in symptoms of children/adolescents following a concussion. The RCT design was chosen as it is considered to provide the most reliable evidence on the effectiveness of the interventions because the processes we will use during the conduct of the RCT minimizes the risk of other factors influencing the results. Our study will assess a home-based individualized graded exercise program tailored for the child and family circumstances (using telehealth) for 4 weeks. This will involve weekly tele-exercise check-in sessions with a study physiotherapist. Here, aerobic exercise activity will gradually increase until pre-injury exercise is achieved. Exercise will be gradually increased based on the child/youth’s perceived exertion (as informed by the 10m Modified Shuttle Test (MST) - ACTR12622001051730). The OMNI (Omnibus) perceived exercise scale has been shown to be comparable to a heart rate monitor. This design allows the exercise program to be developed and tailored to fit patient tolerance levels but also to fit within the family circumstances and equipment. The gradual resumption of activities is based upon the Return to Sport – General Guidelines and Sport Concussion Return to Play Guidelines. The program includes 4 physiotherapy telehealth/phone calls updating a home program, updated weekly in line with symptoms. Our study will differ from other studies as we will be aiming to complete all sessions via a Tele-health model without the need for a heart rate monitor or any other specialized equipment other than access to the internet/video phone. The telehealth sessions with take between 20-45 minutes. These appointments will be conducted weekly, with a minimum of 6 days between appointments and a maximum of 8 days between appointments. The sessions will be run using the same telehealth platform. The physiotherapist will review the participants progress by looking at their Symptom Progress Exercise Diary. If the participant has been able to complete the exercise at the required level for 3 or more days, the exercise intensity will be increased for the following week. If the participant was unable or did not complete the required exercise intervention over the week, the therapist will troubleshoot with the participant to determine the barriers to exercise. The level of exercise intensity prescribed will initially be low (as per results from the 10m MST) with increasing intensity dependent on the participants recovery and symptoms as per the Return to Sport Guidelines for Concussion. Week 1: 15 minutes of exercise at least 3 days per week at their sub-symptomatic OMNI level. Week 2: 20 minutes of exercise at least 3 days per week at their baseline OMNI + 1 level Week 3: 20 minutes of exercise at least 3 times per week at their week 2 OMNI + 1 level Week 4: 30 Minutes of exercise at least 3 times per week at their week 3 OMNI + 1 level The exercises will be based on participant previous physical activities/available home equipment but can include walking around the block, using a stationary bike, using a stationary rowing machine, boxing using a boxing bag - any activity which increases their aerobic output to a level that is comparable to the MST. A specific exercise will not be uniform between patients.

Sponsors

Queensland Children's Hospital - Queensland Paediatric Rehabilitation Service
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

- Any child age 8 to 18 years of age - Mild traumatic brain injury/concussion (as above) - Any increase in symptoms compared to pre-injury symptoms score - Access to device and internet to complete telehealth sessions (Telehealth in the Home checklist) - Overall symptoms of less than 6/10 at rest - Ability to walk independently (eg. Dizziness/imbalance not a risk factor for falls) - Access to space for exercise

Exclusion criteria

- a significant medical history that would contraindicate a home exercise program - a previous concussion within the last 3 months, - persistent symptoms following a previous concussion - inability to complete questionnaires - parents unable to provide informed consent (diminished understanding or comprehension, or a language other than English spoken and an interpreter unavailable), or - inability to provide intervention due to a lack of computer, internet service, or mobile phone

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026