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Trial registered on ANZCTR


Registration number
ACTRN12624001341516
Ethics application status
Approved
Date submitted
7/10/2024
Date registered
5/11/2024
Date last updated
5/11/2024
Date data sharing statement initially provided
5/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating a physical exertion testing protocol in the assessment of balance and visual function following sport-related mild traumatic brain injury (mTBI).
Scientific title
Investigating a physical exertion testing protocol in the assessment of balance and visual function following sport-related mild traumatic brain injury (mTBI) for healthy and mTBI participants aged between 18 - 40 years old
Secondary ID [1] 311599 0
Nil known
Universal Trial Number (UTN)
U1111-1304-4526
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild traumatic brain injury 334909 0
sports-related concussion 334910 0
concussion 335060 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331456 331456 0 0
Physiotherapy
Neurological 331457 331457 0 0
Other neurological disorders
Injuries and Accidents 332051 332051 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to either the physical exertion exposure at their first session, or rest, The physical exertion exposure will be based on the Gapski-Goodman Test (GGT) (Marshall et al., 2019). This involves an initial ramped intensity 8 minute warm up on an exercycle, followed by 2 x 2 minute bursts of high-intensity intervals of maximum effort on for 20 seconds, off for 20 seconds separated by 1 minute of active rest (minimal resistance). Following the bike portion, participants will complete 4 plyometrics stations where they do 2 rounds of 1 minute of an exercise at maximum effort, separated by 30 seconds of rest. The exercises include 40cm box jumps, burpees, jump and turn, and 30cm hurdle step-overs. Participants will be verbally encouraged during plyometrics stages and high intensity exercycle intervals to give their maximum effort. Intensity will be monitored through the use of a heart rate monitor, and Borg Rate of Perceived Exertion (RPE), sampled at the conclusion of the bike portion and plyometrics portion.
This will be completed in a rehabilitation gym setting using standard sized equipment and will be supervised by a registered physiotherapist with 15 years experience, assisted by a research assistant. There will be a maximum of two participants per session. They will return to complete the alternative exposure a minimum of three and a maximum of 10 days later.
Intervention code [1] 329365 0
Rehabilitation
Intervention code [2] 329366 0
Treatment: Other
Comparator / control treatment
If the participant has been randomised to the rest exposure at their first session, they will be asked to rest in a quiet area of the gym. They can listen to music, or relax, but would be requested to avoid using screens during the 25min exposure period. They will return for a second testing session 3-10 days after the first to complete the other exposure.
Control group
Active

Outcomes
Primary outcome [1] 339206 0
Vestibular and Oculomotor performance (assessed as a composite primary outcome during differing conditions of Hart Strings test)
Timepoint [1] 339206 0
1. PRE-1 (Pre-test), (Time +5 for participants)
2. PRE-2 (5 minutes after completion of Pre1), (Time +15 for participants)
3. POST-1 (immediately post exposure), (Time +45 for participants)
4. POST-2 (15 minutes after cessation of exposure) (Time +60 for participants)
5. POST-3 (30 minutes after cessation of exposure). (Time +75 for participants)
Primary outcome [2] 339207 0
Gait and Balance postural sway assessed as a composite primary outcome using different conditions of the Gait & Balance app
Timepoint [2] 339207 0
1. PRE-1 (Pre-test), (Time +5 for participants)
2. PRE-2 (5 minutes after completion of Pre1), (Time +15 for participants)
3. POST-1 (immediately post exposure), (Time +45 for participants)
4. POST-2 (15 minutes after cessation of exposure) (Time +60 for participants)
5. POST-3 (30 minutes after cessation of exposure). (Time +75 for participants)
Primary outcome [3] 339208 0
Feasibility of the research protocol
Timepoint [3] 339208 0
At study conclusion
Secondary outcome [1] 439076 0
Heart rate variability (time and frequency domain measures)
Timepoint [1] 439076 0
HRV-1 (HRV 5-minute reading) = prior to PRE-1 (pre-test) primary measures
HRV-2 (HRV 5-minute reading) = after POST-1 (immediately post exposure cessation) primary measures and 2 min of rest
HRV-3 (HRV 5-minute reading) = after POST-2 (cessation +15min) primary measures and 2 min of rest
Secondary outcome [2] 439077 0
Fidelity - exertion exposure
Timepoint [2] 439077 0
At conclusion of study
Secondary outcome [3] 439078 0
Postural sway - alternative measure
Timepoint [3] 439078 0
1. PRE-1 (Pre-test), (Time +5 for participants)
2. PRE-2 (5 minutes after completion of Pre1), (Time +15 for participants)
3. POST-1 (immediately post exposure), (Time +45 for participants)
4. POST-2 (15 minutes after cessation of exposure) (Time +60 for participants)
5. POST-3 (30 minutes after cessation of exposure). (Time +75 for participants)
Secondary outcome [4] 440754 0
Heart rate,
Timepoint [4] 440754 0
PHYS-1 (HR, RPE) = prior to PRE-2 primary measures
PHYS-2 (HR, RPE): Exercise group: Immediately following the bike sequence. Rest group: PHYS-1 +10 min
PHYS-3 (HR, RPE): Exercise group: Immediately following cessation of exposure, Rest group: PHYS-2 +10 min
PHYS-4 (HR, RPE) = between POST-1 (immediately post cessation) and POST-2 (cessation +15min), prior to HRV-2 measures
Secondary outcome [5] 440755 0
Rate of perceived exertion
Timepoint [5] 440755 0
PHYS-1 (HR, RPE) = prior to PRE-2 primary measures
PHYS-2 (HR, RPE): Exercise group: Immediately following the bike sequence. Rest group: PHYS-1 +10 min
PHYS-3 (HR, RPE): Exercise group: Immediately following cessation of exposure, Rest group: PHYS-2 +10 min
PHYS-4 (HR, RPE) = between POST-1 (immediately post cessation) and POST-2 (cessation +15min), prior to HRV-2 measures
Secondary outcome [6] 440757 0
Safety - exertion exposure
Timepoint [6] 440757 0
Study conclusion
Secondary outcome [7] 440758 0
Adherence - exertion exposure
Timepoint [7] 440758 0
Study conclusion
Secondary outcome [8] 440760 0
Acceptability - exertion exposure
Timepoint [8] 440760 0
Study conclusion

Eligibility
Key inclusion criteria
Group 1: Physically active healthy participants
Inclusion criteria:
i: 18-40 years old
ii: currently participating in organised team sport and/or self-reporting that they participate in moderate and/or vigorous activity for more than 150 minutes per week (as defined in the World Health Organisation (WHO) guidelines).

Group 2: Sports-related mTBI participants who are close to returning to sport
Inclusion criteria:
i: 18-40 years old
ii: currently recovering from a diagnosis of SR-mTBI (sports-related mild traumatic brain injury) within the last six months, and are intending to return to sports
ii: prior to injury, participating in organised team sport and/or self-reporting that they participate in moderate and/or vigorous activity for more than 150 minutes per week (as defined in WHO guidelines).
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group 1: Physically active healthy participants
Exclusion criteria:
i: a self-reported history of mTBI in the previous 12 months or complaining of residual symptoms from a previous mTBI at any point.
ii: self-reported musculoskeletal or medical conditions that limit balance, the ability to participate in exercise and/or performance of the outcome measures (including diagnosed peripheral vestibular conditions such as BPPV, and/or oculomotor or visual problems that are not mitigated with wearing corrective lenses).
iii: self-reported acute illness; or a positive response to any of the COVID-19 screening questions indicating risk of potential infection.

Group 2: Sports-related mTBI participants who are close to returning to sport
Exclusion criteria:
i: a diagnosis of moderate/severe TBI
ii: self-reported musculoskeletal or medical conditions that limit balance, the ability to participate in exercise and/or performance of the outcome measures (including diagnosed peripheral vestibular conditions such as BPPV, and/or oculomotor or visual problems prior to the mTBI that are not mitigated with wearing corrective lenses).
iii: self-reported acute illness; or a positive response to any of the COVID-19 screening questions indicating risk of potential infection.
iiii: have already returned to sport from their most recent mTBI

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic balanced random allocation method via computer schedule will provide a balanced schedule to determine a) the order of rest vs exertion exposure and b) the order of testing measures.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The feasibility measures will be analysed descriptively. The other outcome measures will be examined for inconsistencies or outliers and descriptive statistics (mean, median, and standard deviation) will be calculated for each variable of interest. Normality will be assessed, and transformations applied if appropriate. In the case of persisting violations of non-normality, non-parametric methods will be utilised.

The initial sensitivity of the testing protocol to detect differences in the response to exertion between healthy and mTBI participants will be examined by calculating the effect size for the difference in pre-post exertion effect between healthy and SR-mTBI participants on sensorimotor outcomes. To be sensitive enough for use in a future powered study comparing mTBI versus healthy participants, the target effect size would be at least d = 0.4, to ensure a pragmatic sample size (for example, of 53, with alpha 0.05, power 80%, based on G*Power calculation for a repeated-measures ANOVA) (Faul et al., 2007).

The validity of the sensorimotor measures compared with gold-standard tests will be investigated using Pearson product-moment correlation coefficients.

The reliability of the sensorimotor measures will be explored through analysis of the repeated tests at the pre-exposure timepoints to determine within-session and between-session reliability. The measurement's standard error and intra-class correlation coefficient (ICC) will be calculated. Scatterplots will be generated to allow visual inspection of the data.

If a participant is unable to attend their second testing session or unable to complete a testing session, they will be considered a dropout and reported as such. This will be reflected in the feasibility aims.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/11/2024
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
10/10/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 26528 0
New Zealand
State/province [1] 26528 0
Auckland

Funding & Sponsors
Funding source category [1] 315906 0
Government body
Name [1] 315906 0
Health Research Council of NZ
Country [1] 315906 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Country
New Zealand
Secondary sponsor category [1] 318053 0
None
Name [1] 318053 0
Address [1] 318053 0
Country [1] 318053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314754 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 314754 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [1] 314754 0
New Zealand
Date submitted for ethics approval [1] 314754 0
11/07/2024
Approval date [1] 314754 0
02/09/2024
Ethics approval number [1] 314754 0
2024 FULL 19505
Ethics committee name [2] 316068 0
Auckland University of Technology Ethics Committee
Ethics committee address [2] 316068 0
https://www.aut.ac.nz/research/researchethics
Ethics committee country [2] 316068 0
New Zealand
Date submitted for ethics approval [2] 316068 0
06/09/2024
Approval date [2] 316068 0
04/10/2024
Ethics approval number [2] 316068 0

Summary
Brief summary
People returning to sports after a mild traumatic brain injury (mTBI, also known as a concussion) carry a two times greater risk of a subsequent injury than those without a history of mTBI. This indicates that for some, there is ongoing impairment associated with their mTBI that is responsible for this increased risk, and current return to play (RTP) testing is not sufficient to identify these impairments. Impairments associated with dysfunction of the sensorimotor systems (including balance, vision) have been hypothesised to contribute to this increased risk. The proposed study is part of a series of studies that aim to develop a RTP testing protocol that is more sensitive to the ongoing effects of mTBI. This protocol includes the use of pre- and post- exertion measures because these have been shown to add value to the assessment of concussion in other domains, such as cognition, and incorporates sensorimotor measures. The study hypotheses are a) that the study protocol, and the exertion protocol, will be acceptable and safe for participants and b) that the included measures will have acceptable reliability. Exploratory analysis of the results will allow the required sample size of future studies to be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132618 0
Ms Katherine Forch
Address 132618 0
Auckland University of Technology North Campus, 90 Akoranga Drive, Northcote, Auckland 0627
Country 132618 0
New Zealand
Phone 132618 0
+64 274450595
Fax 132618 0
Email 132618 0
[email protected]
Contact person for public queries
Name 132619 0
Katherine Forch
Address 132619 0
Auckland University of Technology North Campus, 90 Akoranga Drive, Northcote, Auckland 0627
Country 132619 0
New Zealand
Phone 132619 0
+64 274450595
Fax 132619 0
Email 132619 0
[email protected]
Contact person for scientific queries
Name 132620 0
Katherine Forch
Address 132620 0
Auckland University of Technology North Campus, 90 Akoranga Drive, Northcote, Auckland 0627
Country 132620 0
New Zealand
Phone 132620 0
+64 274450595
Fax 132620 0
Email 132620 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.