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The impact of an exercise program on social cognition, psychosocial wellbeing, and physical health in people with traumatic brain injury

The impact of an exercise program on social cognition, psychosocial wellbeing, and physical health in people with traumatic brain injury

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001137886
Enrollment
30
Registered
2021-08-23
Start date
2022-09-01
Completion date
2023-07-01
Last updated
2023-03-06

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

Conditions

None listed

Brief summary

People with traumatic brain injury (TBI) face social isolation and reduced quality of life because of the difficulties they have in recognising and responding to the emotions of others. People with TBI also face substantial health risks because of their low activity levels, which further impacts social engagement and quality of life. Increasing physical activity for people with TBI through a structured exercise program has been shown to improve aspects of cognition (e.g., recall of information) and mood and to decrease symptoms of depression. Given this, it is reasonable to suspect that increased physical activity may also positively impact social cognition for people with TBI. Social cognition is a construct that encompasses a wide array of skills that help people to recognise, accurately interpret, respond to the emotions of others. Some key skills associated with social cognition are facial and vocal emotion recognition, empathy, and social behaviour. The primary aim of the proposed study is to evaluate the impact of increased physical activity on social cognition for people with TBI. Our hypothesis is that the increase in exercise, will have a positive impact on the participants' life, hence increasing their social cognition. The study will include 30 people with moderate to severe TBI who will complete a 12-week supervised exercise program. The exercise program will be individually tailored to accommodate any physical needs participants have and to ensure safe progress throughout. Baseline and post-program measurements will assess social cognition, cognition, community participation, depression and anxiety, and health outcomes which will allow us to explore associations between these various factors. This is a novel study that will inform future, external funding applications.

Interventions

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 m

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.

Sponsors

Central Queensland University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026