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NeuroMuscle Association between acute muscle wasting and functional deficits following severe traumatic brain injury: observational cohort study

NeuroMuscle Association between acute muscle wasting and functional deficits following severe traumatic brain injury: observational cohort study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621001196831
Enrollment
30
Registered
2021-09-08
Start date
2023-04-03
Completion date
2024-02-15
Last updated
2021-09-13

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 study aims to observe acute muscle loss in patients with an acute severe traumatic brain injury over the first 28 days. To date acute muscle loss following the first 7 days following traumatic brain injury has not been reported. This study will assist to determine if there is an association between acute muscle wasting and functional impairments following a severe traumatic brain injury. The study will also determine if enteral or parenteral nutritional intake whilst admitted to intensive care (energy and protein) is associated with acute muscle wasting. This observational study is expected to lay the foundation for future interventional studies to assess the effect of exercise or nutrition (or a combination of both) on muscle loss and functional recovery following a severe traumatic brain injury.

Interventions

To quantify acute phase muscle wasting in critically ill patients post severe traumatic brain injury and determine associations with functional outcomes and nutrition provision. From day 1-2 of intensive care unit (ICU) admission up to 28 days from initial scan. What is involved for participants; a) ultrasound of rectus femoris and vastus intermedius muscles, with each scan taking approximately 15 minutes; the ultrasound assessments will be performed by study researchers who are either physioth

To quantify acute phase muscle wasting in critically ill patients post severe traumatic brain injury and determine associations with functional outcomes and nutrition provision. From day 1-2 of intensive care unit (ICU) admission up to 28 days from initial scan. What is involved for participants; a) ultrasound of rectus femoris and vastus intermedius muscles, with each scan taking approximately 15 minutes; the ultrasound assessments will be performed by study researchers who are either physiotherapists, an intensive care specialist, or sonographers. The ultrasound assessments will be performed at 48 hours from intensive care admission, and 7, 14, 21, and 28 days post-ICU admission. The total duration of observation will be approximately 75 minutes (5 assessment timepoints that each will take approximately 15 minutes to complete). b) Three tests of physical functioning including: 1. 10 metre walk test (day 28 or acute hospital discharge if prior to day 28). 2. Timed up and go (day 28 or acute hospital discharge if prior to day 28). 3. Handgrip strength (day 28 or acute hospital discharge if prior to day 28). Each physical function test will take approximately 5 minutes to complete. These physical function tests will be performed by study researchers who are also physiotherapists. These physical assessments will only be performed once at day 28 or at acute hospital discharge if prior to day 28. The total duration of the physical assessments will be approximately 15 minutes. c) Follow-up phone call or interview 6-months following ICU admission. If the participant has been discharged from the hospital then the interview will be conducted over the telephone. If the participant remains in hospital the interview will be conducted in person. The follow-up will take approximately 15 minutes and the following assessments will be conducted: 1. Days alive and out of hospital, 2. Health related quality of life (EQ5D-5L), 3. Return to work (if working prior to admission), 4. Independence with ADLs (Barthel Index). The follow-up interviews / phone calls will be made by study researchers who are also physiotherapists. Demographic data and nutrition information will also be collected from medical records. Participants will not be required to perform or received any additional tests to ascertain this information. Following person responsible consent the following information will be collected from the patients medical records: Admission injury and illness severity scores (Acute Physiology And Chronic Health Evaluation III (APACHE III), admission Sequential Organ Failure Assessment (SOFA), modified Nutrition Risk Calculation (mNUTRIC) and Glasgow Coma Scale Scores (GCS)), duration of mechanical ventilation (hours), incidence of delirium in ICU (delirium free days) (Cognitive Assessment Measure (CAM ICU)), weight, height, body mass index, adjusted weight, diabetes on admission, nutrition received (name and volume of parental nutrition feed), volume of feed during ICU admission, volume of discarded gastric residual volumes, propofol received, type and volume of carbohydrate infusion, urea level, creatine level, blood glucose levels and units of insulin. Length of stay – ICU, acute hospital, rehabilitation. Acute hospital discharge destination (home, rehab, other hospital, died). Following the provision of consent the person responsible for the participant will be asked a few questions (less than 5 minutes duration) to enable a pre-admission Clinical Frailty Score, and SARC-F questionnaire to be completed. This will assist to quantify the participants pre-admission level of function.

Sponsors

Metro South Health
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Able to have a family member or next of kin consent on the patient’s behalf. 2. Traumatic brain injury (TBI) requiring an intensive care unit admission. Injuries may include: Intracerebral haemorrhage Epidural haemorrhage Subdural haemorrhage Subarachnoid haemorrhage Intraparenchymal Haemorrhage Diffuse axonal injury

Exclusion criteria

1. Dire prognosis (i.e. unlikely to survive the current admission) 2. Spinal cord injury 3. Acute injuries that prohibit ultrasound assessment of thigh musculature i.e. lacerations or open wounds. 4. People who are incarcerated. 5. Women who are pregnant 6. Participants with significant pre-existing cognitive impairment, intellectual disability or mental illness.

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 28, 2026