Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000924257
Ethics application status
Approved
Date submitted
18/05/2018
Date registered
31/05/2018
Date last updated
14/06/2019
Date data sharing statement initially provided
14/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise intervention for slow-to-recover mild traumatic brain injury patients
Scientific title
ACTIVity and Exercise for TBI (ACTIVE-TBI) exercise intervention to reduce postconcussion symptoms in slow-to-recover mild traumatic brain injury patients
Secondary ID [1] 294422 0
Nil known
Universal Trial Number (UTN)
U1111-1211-2870
Trial acronym
ACTIVE-TBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Slow-to-recover from mild traumatic brain injury
 307169 0
Condition category
Condition code
Neurological 306282 306282 0 0
Other neurological disorders
Injuries and Accidents 307132 307132 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will attend the health clinic 3 times per week and undertake the ACTIVE-TBI protocol with the direct guidance of an accredited exercise physiologist. Pre and post measures of cognitive performance and DTI neuroimaging will be taken for all eligible participants.

Prescribed exercise commences as soon as feasible after study entry. The delivery of the intervention is closely supervised by an experienced, Exercise and Sports Science Australia (ESSA) AEP.

The Intervention Protocol incorporates: a) strictly defined warm-up and cool down-periods; b) a work phase (a circuit program that ensures sequenced exercises for antagonistic muscle groups); and c) cessation rules (the American College of Sports Medicine (ACSM) Guidelines).

The work phase involves individually-prescribed, supervised, and graded circuit resistance training. The requirements are individually determined using 1-Repetition Maximum (1-RM) strength testing for leg press, chest press and back pull exercises. The same person assesses the 1-RM attempts for all participants. The work phase dose for each participant is set at 50% of 1-RM, which is classified by ACSM as light intensity.

The clinic is equipped with pneumatic resistance training machines, specially designed for clinical populations (Ab HUR Oy, Finland). These machines enable precise quantification of resistance, and automated load control, which aids accuracy, safety, and usability (users do not require prior experience with exercise machines). This equipment electronically records all individual work phase data (intensity, volume).

The work phase comprises 13 light-resistance machine-based exercises in each aerobic circuit (chest press, leg press, shoulder press, lat pulldown, lat row, abdominals, back extension, tricep push down (cable), seated bicep curl (cable) and leg extension, leg curl, leg abduction and adduction). Participants will exercise for a 30-second period that includes 20 repetitions at the prescribed load, followed by a 30-second rest. All intervals are timed by the supervisor. The training is graduated by: a) increasing session duration e.g., from week, 1 circuit (12 mins) and up to week 8, 4 circuits (48 min), and; b) two repeat 1-RM tests (Weeks 3, 5) for revised load prescription, if required.

There are 8 weeks with 3 training sessions per week (24 sessions, total). The session duration varies as noted above. There is one session per day, with a minimum of 48 hours rest in between sessions. The pre and post assessments occur in the week immediately pre and post the intervention, respectively.

Participants in the ACTIVE-TBI group will be eligible to discontinue the exercise program if they meet any of the following criteria:

The participant is no longer at risk of persistent symptoms (measured using the RPQ-3)
Have been medically cleared to return to contact sport by their doctor.

1. American College of Sports Medicine Guidelines for exercise testing & prescription. 2014. (9th ed.).Baltimore: Lippincott Williams & Wilkins.
Intervention code [1] 300715 0
Other interventions
Comparator / control treatment
The control group will receive treatment as usual and receive no instructions beyond those provided by their doctor. Participants in the treatment as usual group will have their symptoms monitored and receive two health fitness assessments, at baseline and 8-10 weeks.
Control group
Active

Outcomes
Primary outcome [1] 305286 0
Neurobehavioural symptoms indicative of PCS diagnosis measured using the Rivermead Post Concussion Symptom Questionnaire.
Timepoint [1] 305286 0
Baseline and within one week post-intervention completion
Secondary outcome [1] 344734 0
Physical fitness assessed by an Accredited Exercise Physiologist using standard anthropometric measures include Weight (kg), Height (cm) and BMI (kg/m2); tape-measured assessment of waist and hip circumference; 6-min walk: distance (m) + speed (m/sec) + heart rate (9); and chest, hand grip (10), back and leg dynamometer strength testing (kg).
Timepoint [1] 344734 0
Baseline and within one week post-intervention completion
Secondary outcome [2] 345812 0
Health service utilisation measured by patient-reported, via a project questionnaire.
Timepoint [2] 345812 0
Within one week post-intervention completion
Secondary outcome [3] 347527 0
Return to work or study measured by patient-reported, via a project questionnaire
Timepoint [3] 347527 0
Baseline and within one week post-intervention completion
Secondary outcome [4] 371551 0
As an exploratory outcome, Diffusion Tensor Imaging measures (e.g. Mean Diffusivity (MD), fractional anisotropy (FA), radial diffusivity (RD) and axial diffusivity (AD)) will be taken before and after the intervention. MRI scanning will be carried out at the Herston Imaging Research Facility (HIRF) at Royal Brisbane Women Hospital.
Timepoint [4] 371551 0
Baseline and within one week of post-intervention completion
Secondary outcome [5] 371552 0
Cognitive functioning before and after the intervention using the National Institute of Health (NIH) Toolbox cognitive measures.
Example:
- Attention assessed using the NIH toolbox Flanker Control and Attention test
- Processing speed assessed using the NIH toolbox pattern comparison processing speed test
- Executive functioning assessed using the NIH toolbox dimensional change card sort test
Timepoint [5] 371552 0
Baseline and within one week of post-intervention completion

Eligibility
Key inclusion criteria
1. Arrive at ETC within 24 hours of injury; aged 18-65 years; adequate English.
2. Their mTBI is assessed medically by conventional standards, (i) greater than or equal to 1 of the following: confusion or disorientation; loss of consciousness for less than or equal to 30 minutes; posttraumatic amnesia less than 24 hours; and/or other transient neurological abnormalities such as focal signs, seizure, and intracranial lesion not requiring surgery, and; (ii) Glasgow Coma Scale of 13–15 at least 30 minutes post injury or later upon presentation for healthcare (all data are extracted); and iii) are medically cleared (not requiring neurosurgical follow-up).
3. They are willing to attend two fitness tests about 8 – 10 weeks apart, and if allocated to the gym group, to attend 3 gym sessions per week in between fitness tests.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. They are a follow up risk (e.g. interstate visitor, pregnant, require a transfer).
2. They have pre-existing or comorbid conditions that could confound neurobehavioural assessment (e.g. prior/current diagnosis of dementia/neurological condition, or intellectual disability; history of moderate or severe TBI; other significant medical conditions (e.g. cancer).
3. Their Index injury is not mild (it is moderate or severe) or there is significant co-occurring bodily injury (e.g. referral for outpatient rehabilitation (indicative of complications)).
4. At 3 weeks post injury they are not ‘at-risk’ of postconcussion symdrome (measured using RPQ-3 score)
5. At first fitness test there are exercise contraindications formally assessed as per the ACSM Guidelines.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Group comparisons will be made using GEE or GLMM to control for baseline. Pre-to-post comparisons will be via One-Way ANOVA using an intention-to-treat analysis. Correlations will be used to capture the expected decrease in participants meeting criteria for postconcussion syndrome pre to post intervention. Descriptive data will be used to capture symptom reduction will be associated with improvements in secondary outcomes. Symptom differences between the treatment as usual and ACTIVE-TBI participants are tested with ANOVA at program end.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/06/2019
Actual
Date of last participant enrolment
Anticipated
18/06/2021
Actual
Date of last data collection
Anticipated
20/08/2021
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10447 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 22156 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 299052 0
Charities/Societies/Foundations
Name [1] 299052 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 299052 0
Australia
Funding source category [2] 299054 0
University
Name [2] 299054 0
Queensland University of Technology School of Exercise and Nutrition Sciences
Country [2] 299054 0
Australia
Funding source category [3] 299329 0
University
Name [3] 299329 0
Queensland University of Technology School of Exercise and Nutrition Sciences
Country [3] 299329 0
Australia
Primary sponsor type
Individual
Name
Karen Sullivan
Address
School of Psychology and Counselling, Kelvin Grove Campus, Queensland University of Technology, Victoria Park Road, Kelvin Grove 4059, Queensland Australia.
Country
Australia
Secondary sponsor category [1] 298289 0
None
Name [1] 298289 0
Address [1] 298289 0
Country [1] 298289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299986 0
Royal Brisbane and Women’s Hospital HREC (EC00172)
Ethics committee address [1] 299986 0
Ethics committee country [1] 299986 0
Australia
Date submitted for ethics approval [1] 299986 0
07/06/2018
Approval date [1] 299986 0
25/03/2019
Ethics approval number [1] 299986 0
HREC/18/QRBW/366 (ERM ID: 41399)

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

Contacts
Principal investigator
Name 82170 0
Prof Karen Sullivan
Address 82170 0
School of Psychology and Counselling, O Block B Wing Room 523, Kelvin Grove Campus, Queensland University of Technology, Victoria Park Road, Kelvin Grove 4059, Queensland Australia
Country 82170 0
Australia
Phone 82170 0
+61 7 3138 4609
Fax 82170 0
Email 82170 0
[email protected]
Contact person for public queries
Name 82171 0
Karen Sullivan
Address 82171 0
School of Psychology and Counselling, O Block B Wing Room 523, Kelvin Grove Campus, Queensland University of Technology, Victoria Park Road, Kelvin Grove 4059, Queensland Australia
Country 82171 0
Australia
Phone 82171 0
+61 7 3138 4609
Fax 82171 0
Email 82171 0
[email protected]
Contact person for scientific queries
Name 82172 0
Karen Sullivan
Address 82172 0
School of Psychology and Counselling, O Block B Wing Room 523, Kelvin Grove Campus, Queensland University of Technology, Victoria Park Road, Kelvin Grove 4059, Queensland Australia
Country 82172 0
Australia
Phone 82172 0
+61 7 3138 4609
Fax 82172 0
Email 82172 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.