Clinical trial NCT06431139: Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury
Official title: Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury - a Randomised Pilot and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury
Intensive exercise
Rehabilitation
Randomised trial
Feasibility
Pilot
Sit-to-stand exercise
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this randomised multicentre clinical feasibility and pilot trial is to test if a sit-to-stand trial protocol is feasible regarding the increased intensity, trial recruitment, and completion of outcome data in patients with moderate to severe traumatic brain injury during the rehabilitation phase. For the trial to be feasible, all outcomes must be achieved.

The primary hypothesis is that it is feasible to progressively increase the number of repetitions of sit-to-stand exercises in patients with moderate to severe traumatic brain injury admitted to a rehabilitation department during the intervention period.

Furthermore, the investigators hypothesize that the increased number of repetitions will increase the participant's functional capabilities regarding sit-to-stand and walking, decrease resting heart rate, blood pressure, and metabolism, reduce inflammatory and brain injury biomarkers, and improve the cognitive performance.

Detailed description: This is a randomised multicentre clinical feasibility and pilot trial, where assessors and statisticians will be blinded. Forty-four participants with moderate to severe traumatic brain injury will be randomised to INSPIRE versus standard care as soon as they are able to understand and execute simple commands twice during one day. Participants in the INSPIRE group will undergo two weeks of intensive sit-to-stand exercise using an algorithm to increase the intensity daily. The trial uses predefined dose-limiting events to reduce training intensity in participants experiencing exercise-related adverse events that limit other daily activities and rehabilitation (e.g. muscle soreness and pain). Overall feasibility will be assessed by determining the inclusion rate, exercise completion rate, and completion of the Glasgow Outcome Scale - Extended. As exploratory clinical outcomes, the investigators will assess serious adverse events and adverse events not considered serious, physical function, cardiovascular and metabolic health, fatigue, and cognitive function.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe traumatic brain injury with Glasgow Coma Score \<13 within the first 24 hours (ICD10, DS06)
* Admitted for rehabilitation at the Department of Brain and Spinal Cord Injury, Division of Brain Injury, Rigshospitalet, the Regional Hospital, Hammel Neurocentre or the Acquired Brain Injury Rehabilitation Centre, Alfred Hospital
* 18 years old or older
* Patients (or next of kin) should be able to understand written and spoken Danish or English to consent to participation in the trial validly
* Specifically for Australian participants: eligibility for Medicare

Exclusion Criteria:

* Unstable fractures of the lower extremities
* Amputation of lower extremity
* Spinal cord injury
* Total paralysis of both lower extremities
* Agitated or combative behaviour
* Diagnosed with a progressive neurological disorder (e.g. Alzheimer's, Parkinson's disease, multiple sclerosis) prior to traumatic brain injury, as it could potentially interfere with serum biomarker levels
* Previous structural brain injury (e.g. stroke or brain surgery)
* No valid consent from the participant or next of kin

Primary outcomes:
measure: Number of sit-to-stand
timeFrame: during the intervention
Secondary outcomes:
measure: The number of participants included in the trial
timeFrame: 1,5 years
measure: Participants completing GOSE
timeFrame: 6 months, 1 year
Other outcomes:
measure: Dose-limiting events
timeFrame: during the intervention, 72-hours after end of intervention
measure: Glasgow Outcome Scale - Extended
timeFrame: at discharge, 6 months, 1 year
measure: Number of sit-to-stand exercises in each group during the intervention period (continuous outcome)
timeFrame: during the intervention
measure: Number of sit-to-stand exercises during the 30-second chair stand test (continuous outcome)
timeFrame: Baseline, 1 day after the intervention
measure: Walkers and non-walker (dichotomous outcome)
timeFrame: Baseline, 1 day after the intervention
measure: 10-meter walk test (continuous outcome)
timeFrame: Baseline, 1 day after the intervention
measure: 6-minute walking test (continuous outcome)
timeFrame: Baseline, 1 day after the intervention
measure: Resting blood pressure
timeFrame: Baseline, 1 day after the intervention
measure: Resting heart rate
timeFrame: Baseline, 1 day after the intervention
measure: Blood samples
timeFrame: Baseline, 1 day after the intervention
measure: The Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 1 day after the intervention, 6 months, 1 year
measure: Fatigue severity scale (FSS)
timeFrame: Baseline, 1 day after the intervention, 6 months, 1 year
Locations:
Study officials:
affiliation: Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet
name: Christian G Riberholt, PT, MR, PhD
role: STUDY_DIRECTOR
affiliation: Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet
name: Christina G Kruuse, Professor
role: STUDY_DIRECTOR
References: