Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001549718
Ethics application status
Approved
Date submitted
2/12/2022
Date registered
15/12/2022
Date last updated
15/12/2022
Date data sharing statement initially provided
15/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Concussion GYM-T: Graded exercise in Youth to Maximise early recovery using Tele-exercise model: A Randomised Control Trial
Scientific title
Concussion GYM-T: Graded exercise in Youth to Maximise early recovery using Tele-exercise model: A Randomised Control Trial
Secondary ID [1] 308502 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion / Mild Traumatic Brain Injury 328317 0
Condition category
Condition code
Neurological 325358 325358 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 325359 325359 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 324985 0
Rehabilitation
Comparator / control treatment
Standard Care (SC):
The Standard Care group will receive a Nurse-led education via a phone call within 2 weeks of referral providing concussion management strategies including advice, reassurance, and educational resources including information regarding concussion, return to school and physical activity guidelines, sleep, headaches and fatigue. The Standard Care education is provided verbally as well as via email/mail. The families are directed to the kidsconcussion.com.au website for accurate and reliable information on their recovery. Families are also provided with the contact details of the QPRS reception which the families can call with any additional questions. Families are directed to call back if their child is not recovering as expected or if they are having increased issues with their symptoms. Families are only booked into a clinic appointment if the families re-contact our department. If they do not call back, we assume recovery or they have sought help elsewhere. For the purpose of this study, all children who are randomised to Control Group will receive a follow up phone call at 4 weeks to re-do the PSCI with nursing. Children will be scheduled an appointment immediately if there are any Red Flags identified as per the PACE. These children would not be eligible for this study as per our eligibility criteria. The standard care phone call average duration is 30-60 minutes depending on the participant needs.
Control group
Active

Outcomes
Primary outcome [1] 333272 0
Post Concussion Symptom Inventory (PSCI) change
Timepoint [1] 333272 0
PSCI - Initial Contact with Nursing Staff (Both sides of RCT)
PSCI - Week 1 (Initial Tele-exercise appointment (Intervention Group)
PSCI - Week 5 Either RedCap or Nursing Phone Call (Both sides of RCT)
Secondary outcome [1] 416423 0
Pediatric Quality of Life Inventory (PedsQL)
Timepoint [1] 416423 0
Initial Nursing phone call (both sides of RCT)
Week 1 - Initial Tele-exercise session (intervention Group only)
Week 5 - Either RedCap or Nursing Phone Call
Secondary outcome [2] 416424 0
Child Health Utility instrument (CHU9D) - used to measure of health-related quality of life. It consists of a short questionnaire and a set of preference weights using general population values. The questionnaire has 9 questions with 5 response levels per question and is self-completed by the child.
Timepoint [2] 416424 0
Initial Nursing phone call (both sides of RCT)
Week 1 - Initial Tele-exercise session (intervention Group only)
Week 5 - Either RedCap or Nursing Phone Call

Eligibility
Key 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
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomization strategy used will be Minimisation. This is used when randomizing the two treatment categories, stratifying for age, sex and previous prolonged recovery following mTBI (<1 week or >1 week) using MiniRand in R. This will allow us to account for the strong influence of age, sex and prior history of prolonged symptoms following mTBI (Zemek, 2016). The treatment allocation will be concealed until after all pre-treatment assessments have been completed. The treatment group will then be allocated using a computer algorithm using minirand by a member of the ABIC research team not involved in the study. The outcome assessor will be blinded to the group assignment however the physiotherapist and research assistant providing the treatments will not be blinded to the allocation. The participant and their family will not be blinded to the treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Mixed effect statistical model will be used to analyze the effect of group (SC vs exercise) on PCSI change (pre – post PCSI), allowing for age, sex, and time post injury (fixed effect), and participant (random effect) with a significance level of p=.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/04/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 23666 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 39092 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 312742 0
Hospital
Name [1] 312742 0
Children's Health Queensland - Study and Education Research Trust Account
Country [1] 312742 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital - Queensland Paediatric Rehabilitation Service
Address
Queensland Children's Hospital -
Queensland Paediatric Rehabilitation Service
Level 6G
Stanley St
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 314423 0
None
Name [1] 314423 0
Address [1] 314423 0
Country [1] 314423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312047 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 312047 0
Ethics committee country [1] 312047 0
Australia
Date submitted for ethics approval [1] 312047 0
12/07/2022
Approval date [1] 312047 0
20/07/2022
Ethics approval number [1] 312047 0
HREC/22/QCHQ/87292

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123266 0
Mrs Kirrilee Smith
Address 123266 0
Queensland Children's Hospital
Queensland Paediatric Rehabilitation Service
Level 6G
401 Stanley St
South Brisbane QLD 4101
Country 123266 0
Australia
Phone 123266 0
+61 7 30682950
Fax 123266 0
Email 123266 0
[email protected]
Contact person for public queries
Name 123267 0
Kirrilee Smith
Address 123267 0
Queensland Children's Hospital
Queensland Paediatric Rehabilitation Service
Level 6G
401 Stanley St
South Brisbane QLD 4101
Country 123267 0
Australia
Phone 123267 0
+61 7 30682950
Fax 123267 0
Email 123267 0
[email protected]
Contact person for scientific queries
Name 123268 0
Kirrilee Smith
Address 123268 0
Queensland Children's Hospital
Queensland Paediatric Rehabilitation Service
Level 6G
401 Stanley St
South Brisbane QLD 4101
Country 123268 0
Australia
Phone 123268 0
+61 7 30682950
Fax 123268 0
Email 123268 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data ONLY. Demographic and injury characteristics, outcome measures, dose, trial report data
When will data be available (start and end dates)?
Upon publication of the study. No end date determined
Available to whom?
Researchers with a reasonable research question will be considered
Available for what types of analyses?
Any reasonable research question
How or where can data be obtained?
Data will be shared via a secure link from the principle investigator (Kirrilee Smith). Contacted via email [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.