Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001137886
Ethics application status
Approved
Date submitted
16/06/2021
Date registered
23/08/2021
Date last updated
24/02/2023
Date data sharing statement initially provided
23/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of an exercise program on social cognition, psychosocial wellbeing, and physical health in people with traumatic brain injury
Scientific title
The impact of an exercise program on social cognition, psychosocial wellbeing, and physical health in people with traumatic brain injury
Secondary ID [1] 304452 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Traumatic Brain Injury 322269 0
Depression 322270 0
Social Cognition 322271 0
Physical inactivity 322272 0
Psychosocial wellbeing 322273 0
Condition category
Condition code
Mental Health 319953 319953 0 0
Depression
Mental Health 319954 319954 0 0
Anxiety
Neurological 319955 319955 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 319956 319956 0 0
Other physical medicine / rehabilitation
Public Health 319957 319957 0 0
Health promotion/education
Injuries and Accidents 320357 320357 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention exist of a 12-week exercise program for the participants.
Prior to commencing the exercise program, participants will participate in a one-on-one consultation with an accredited exercise physiologist (AEP), in a 1-hour session. The AEP will select exercises for each individual’s program. This is particularly important for people with Traumatic Brain Injury (TBI) to ensure that the program is tailored according to the type and severity of their impairments (e.g., altered joint mechanics due to changes in muscle tone that have occurred post-injury) and thus accommodates their personal characteristics, as well as their baseline physical health and physical activity status. Following this, participants will meet with the AEP fortnightly for 30 min, to conduct follow-up consultations for the purpose of reviewing progress, monitoring technique and movement to minimise injury risk, and implementing modifications to the program accordingly. This consultation will take place during one of their weekly exercise visits in the CQUniversity Rockhampton gym. It will allow the AEP to monitor the participants and adjust the program as needed.
The systematic review by Vanderbeken and Kerckhofs (2017), reported cognitive gains in exercise programs, lasting eight weeks or more. Overall results show supporting evidence for a combination of aerobic and resistance training to have significant improvements on several cognitive measures (Kluding et al., 2011; Marzolini et al., 2013). These guidelines detailing the length (Vanderbeken et al, 2017) and content (Kluding et al., 2011; Marzolini et al., 2013) have been considered in the individual design of the 12-week intervention program, that will be executed by an accredited Exercise Physiologist.
Each participant’s exercise program will comprise approximately 20 minutes aerobic exercise (cycle or walking) at moderate intensity (~65% age-predicted maximal heart rate) and approximately 30 minutes of resistance exercise per session (free weights, resistance training machines, resistance tubing/bands) (3 times per week). This protocol is chosen as it incorporates the guidelines for cardiorespiratory and endurance training for people with TBI proposed by Mossberg, Amonette, and Masel (2010), alongside guidelines for developing musculoskeletal and neuromotor fitness for healthy adults (Garber et al., 2011). In addition, this protocol replicates exercise interventions typically undertaken at commercial fitness centers which will allow for easy translation to self-managed exercise on completion of the intervention, should participants so desire. The resistance exercise program will include approximately eight compound (multi-joint) exercises which focus on large muscle groups. Each exercise will be undertaken for two sets of 8-15 repetitions, with approximately one-minute rest between sets, at moderate intensity.
Following the initial consultation with the accredited exercise physiologist, participants will begin their 12-week exercise program. On odd-numbered weeks (e.g., 1, 3, 5, etc.), participants will attend 3 gym sessions per week at the CQUniversity Community Sports Centre. In even-numbered weeks (e.g., 2, 4, 6, etc.), participants will have their fortnightly follow-up session with the exercise physiologist during one of their regular sessions. The AEP will visit the CQUniversity gym to monitor the participants during their program and make adjustments if necessary. They will attend 3 gym sessions at the CQUniversity Community Sports Centre in the even-numbered weeks, including the above described session where the AEP will be present. Sessions will be completed independently, but participants will be contacted at the start of each week to remind them of any upcoming appointments with the accredited exercise physiologist and to remind them to attend their independent gym sessions. Outside of text-based reminders, Participants will be asked to collect their program from the reception staff at the gym, as well as fill out the Borg Rating of Perceived Exertion Scale upon finishing their session. The lead investigator will be in close contact with reception staff to collect this data and monitor participants' adherence to the program.
Intervention code [1] 320849 0
Rehabilitation
Comparator / control treatment
There will be no control group in this study. All participants will be allocated to the intervention group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327872 0
Differences in social cognition as measured by the Diagnostic Analysis of Non-Verbal Accuracy-2 Adult Facial expressions (DANVA 2-AF), Emotion Recognition Task (ERT), Toronto Alexithymia Scale (TAS-20) and Interpersonal Reactivity Index (IRI).
This primary outcome is a composite outcome comprised of facial recognition (DANVA-2 AF), emotion recognition (ERT), alexithymia (TAS-20), and empathy or the lack thereof (IRI).
Timepoint [1] 327872 0
Baseline, after completion of 12-week exercise program (should be in week 13), 12-weeks post their exercise program (week 25)
Primary outcome [2] 327873 0
Differences in Cognition as measured by the Trial Making Test (TMT), the Digit Span subtest from the Wechsler Adult Intelligence Scale IV (WAIS-IV) and the Arithmetic subtest from the WAIS-IV. Cognition is a composite primary outcome that includes executive functioning (TMT), verbal working memory (Digit Span and arithmetic from WAIS-IV).
Timepoint [2] 327873 0
Baseline, after completion of their 12-week exercise program (week 13), 12 weeks post their exercise program (week 25)
Primary outcome [3] 327874 0
Difference in Quality of Life, as measured by the 36-Item Short Form Health Survey (SF-36).
Timepoint [3] 327874 0
Baseline, After completion of their 12-week exercise program (week 13), 12 weeks post completion of their 12-week exercise program (week 25)
Secondary outcome [1] 396824 0
Difference in mental health scores, as measured by the DASS-21 scale.
Mental Health will be assessed as a composite secondary outcome.
Timepoint [1] 396824 0
Baseline measurement, after completion of their 12-week exercise program (week 13) and 12 weeks post their exercise program (week 25)
Secondary outcome [2] 396825 0
Difference in exercise capability, as measured by the Six-Minute Walking Test (6MWT).
Timepoint [2] 396825 0
Baseline measurement, after completion of their 12-week exercise program (week 13), and 12 weeks after the completion of their exercise program (week 25)
Secondary outcome [3] 398077 0
Difference in Social Reintegration, as measured by the Sydney Psychosocial Reintegration Scale 2 (SPRS-2)
Timepoint [3] 398077 0
Baseline measurement, after completion of their 12-week exercise program (week 13), and 12 weeks after the completion of their exercise program (week 25)
Secondary outcome [4] 398078 0
Difference in executive functioning, as measure by the Dysexecutive Questionnaire Revised (DEX-R)
Timepoint [4] 398078 0
Baseline measurement, after completion of their 12-week exercise program (week 13), and 12 weeks after the completion of their exercise program (week 25)
Secondary outcome [5] 398082 0
Difference in cardiovascular system and stress, as measured by Heart Rate Variability through the Polar RS800 watch and Heart Rate band.
Timepoint [5] 398082 0
Baseline measurement, after completion of their 12-week exercise program (week 13), and 12 weeks after the completion of their exercise program (week 25)
Secondary outcome [6] 399056 0
Difference in muscle strength as measured by a JAMAR hydraulic dynamometer
Timepoint [6] 399056 0
Baseline measurement, after completion of their 12-week exercise program (week 13), and 12 weeks after the completion of their exercise program (week 25)

Eligibility
Key inclusion criteria
Severity of TBI will be determined by the following criteria: Glasgow Coma Scale score of less than or equal to 8 at time of injury, post-traumatic amnesia (PTA) of more than or equal to 7 days, or loss of consciousness of more than or equal to 24 hours (Zupan & Neumann, 2016). This information will be obtained via medical records (with participant consent) or via self/caregiver report if medical records are unavailable (Neumann et al., 2015). Participants will be at least 1-year post-injury (Neumann et al., 2015; Vanderbeken & Kerckhofs, 2017), English speaking, and ambulatory.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they already participate in a structured exercise program and/or participate in more than 90 minutes of moderate to vigorous physical activity per week. Participants will also be excluded if they are unable to give informed consent, unable to follow simple verbal directions, have a diagnosed neurogenerative disorder (e.g., dementia) or self-reported alcohol/drug dependency.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
All participants will allocated to the intervention group
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis for the evaluation of this randomised controlled trial will use multilevel modelling in R (Bates et al., 2014) to test the effects of the intervention on the outcomes of social cognition, cognition, social participation, and physical and mental health. Given that there are two groups, including a waitlist control with an additional assessment, time will be estimated as a categorical comparison (‘pre-baseline’ [for waitlist control only], ‘baseline’, ‘post intervention’, and ‘follow-up’). rather than as linear time. This approach will allow for multiple planned comparisons (e.g., baseline to post intervention; post intervention to follow-up, etc.).
Prior to analyses, two types of potential data missingness will be evaluated and treated. The first would be drop-out of participants, which will be managed via Intention to Treat (Laan & Petersen, 2007). Additionally, any missing data unrelated to drop-out will be imputed through MICE (Multiple Imputation by Chained Equations) (Buuren & Groothuis-Oudshoorn, 2011). Additionally, assumption testing will be conducted to ensure the residuals are normally distributed and the cell-sizes are sufficient for generalizability of comparisons.
Prior to the analysis of the research questions, the assumptions of a multiple linear regression model will be tested. Hence, normality and homoscedascity of residuals as well as multicollinearity testing in R will take place. The testing of multicollinearity can occur via a Variance Inflation Factor (VIF) test and the investigation of correlations between dependent variables. Furthermore, the researcher will look at the outliers and the normal distribution of residuals, at the same time checking the model for overfitting.
For research question 1, (what is the impact of a structured exercise program on social cognition for people with TBI?), the dependent variable, social cognition, will be regressed onto time (categorical variable: ‘pre-baseline’ [for waitlist control only], ‘baseline’, ‘post intervention’, and ‘follow-up’) and intervention group (waitlist control vs immediate intervention). The hypothesis will be tested with the planned comparison of “baseline” to “post-intervention” and “post-intervention to follow-up”, while also looking at a comparison between “post-intervention” to “follow-up”.
Research questions 2 to 5 will follow the same procedure with a difference in dependent variables. These dependent variables include cognition (question 2), social participation (question 3), physical measures (question 4), and mental health measures (question 5).
The investigation of correlations between dependent measures is the sixth research question, where Pearson’s bivariate correlations will help answering that question.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/09/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2023
Actual
Date of last data collection
Anticipated
28/12/2023
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 34384 0
4701 - Central Queensland University

Funding & Sponsors
Funding source category [1] 308812 0
University
Name [1] 308812 0
Central Queensland University
Country [1] 308812 0
Australia
Primary sponsor type
University
Name
Central Queensland University
Address
554-700 Yaamba Rd,,
Norman Gardens, Rockhampton
QLD 4701
Country
Australia
Secondary sponsor category [1] 309731 0
None
Name [1] 309731 0
Address [1] 309731 0
Country [1] 309731 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308726 0
Human Ethics Committee, Central Queensland University
Ethics committee address [1] 308726 0
Ethics committee country [1] 308726 0
Australia
Date submitted for ethics approval [1] 308726 0
01/02/2019
Approval date [1] 308726 0
29/06/2021
Ethics approval number [1] 308726 0
0000021582

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

Contacts
Principal investigator
Name 111678 0
Mr Tom De Pauw
Address 111678 0
Central Queensland University,
Building 6, Office 2.15
554-700 Yaamba Rd,
Norman Gardens, Rockhampton
QLD 4701
Country 111678 0
Australia
Phone 111678 0
+61749309534
Fax 111678 0
Email 111678 0
[email protected]
Contact person for public queries
Name 111679 0
Tom De Pauw
Address 111679 0
Central Queensland University,
Building 6, Office 2.15
554-700 Yaamba Rd,
Norman Gardens, Rockhampton
QLD 4701
Country 111679 0
Australia
Phone 111679 0
+61749309534
Fax 111679 0
Email 111679 0
[email protected]
Contact person for scientific queries
Name 111680 0
Tom De Pauw
Address 111680 0
Central Queensland University,
Building 6, Office 2.15
554-700 Yaamba Rd,
Norman Gardens, Rockhampton
QLD 4701
Country 111680 0
Australia
Phone 111680 0
+61749309534
Fax 111680 0
Email 111680 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
1) we are not collecting consent to share IPD in any format
2) the funder does not require data sharing to occur


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.