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Exercise intervention for slow-to-recover mild traumatic brain injury patients

ACTIVity and Exercise for TBI (ACTIVE-TBI) exercise intervention to reduce postconcussion symptoms in slow-to-recover mild traumatic brain injury patients

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000924257
Acronym
ACTIVE-TBI
Enrollment
50
Registered
2018-05-31
Start date
2019-06-20
Completion date
2021-06-18
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

This project establishes a proof of concept for an intervention that uses prescribed physical activity intervention, ACTIVE-TBI, to stop the progression of postconcussion symptoms. In patients slow-to-recover from mTBI, persistent postconcussion symptoms adversely impact on patients’ productivity, relationships, and quality of life. We predict a reduction in postconcussion symptoms after the physical activity intervention, ACTIVE-TBI. Other expected outcomes include: decrease of return-to-work or study times; decreased health service utilisation, and improved recovery outlook.

Interventions

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 P

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.

Sponsors

Karen Sullivan
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026