Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury

NCT06431139 | Not Yet Recruiting

• 1 other identifier: H-24001505
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; Intensive exercise; Rehabilitation; Randomised trial; Feasibility; Pilot; Sit-to-stand exercise

Outcome Measures

Primary Outcomes (1)

• Number of sit-to-stand

  The difference in the number of sit-to-stand performed in the INSPIRE group compared to the control group using linear regression during the two-week intervention period.

  during the intervention

Secondary Outcomes (2)

• The number of participants included in the trial

  1,5 years

• Participants completing GOSE

  6 months, 1 year

Other Outcomes (12)

• Dose-limiting events

  during the intervention, 72-hours after end of intervention

• Glasgow Outcome Scale - Extended

  at discharge, 6 months, 1 year

• Number of sit-to-stand exercises in each group during the intervention period (continuous outcome)

  during the intervention

Study Arms (2)

INSPIRE group

EXPERIMENTAL

Intervention group. Daily intensive sit-to-stand exercises following a described algorithm and utilising motor-relearning principles of feedback to increase the participant's motivation. This exercise is an addition to standard care.

Other: INSPIRE intervention protocol

Standard care group

NO INTERVENTION

Treatment in this group will be standard care interventions performed at the rehabilitation department.

Interventions

INSPIRE intervention protocol OTHER

2-week training program with daily sit-to-stand exercises. Each working day the participant's goals will be adjusted, until exercising a minimum of 100 repetitions using an exercise progression table. When participants complete one level, they will progress to the next level the following day. Participants who do not reach the goals at level one will continue to strive to reach the 100 repetitions. The number of repetitions can be split and performed throughout the day. As the participants' capacity for doing the exercises increases, so will the number of repetitions within each bout of sit-to-stand. Participants are allowed to do the number of repetitions from a higher exercise level if they can and will continue by progressing from that level on the next day. The repetitions will be done from a height that makes it possible to accomplish the sit-to-stand movement. Therefore, the height of the sitting surface will be adjusted according to the participant's abilities.

INSPIRE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Riberholt: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Christian G Riberholt, PT, MR, PhD

  Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

• Christina G Kruuse, Professor

  Dept. of Brain and Spinal Cord Injury, Division of Brain Injury, Copenhagen University Hospital - Rigshospitalet

  STUDY DIRECTOR

Central Study Contacts

Yasemin Ronahi Kücük, M.D

CONTACT

+4527841237; yasemin.ronahi.kuecuek@regionh.dk

Christian G Riberholt, PT, MR, PhD

CONTACT

christian.gunge.riberholt@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trial will use assessors blinded to the allocation and in charge of testing the following outcomes: 30 seconds chair stand test, 10-meter walk test, 6-minute walking test, and the Montreal Cognitive Assessment Scoring (MoCA) Two statisticians that will perform the statistical analysis are blinded to the allocation
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of therapy and senior researcher, PT, MR, PhD

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 28, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2025
• Study Completion: January 31, 2026
• Last Updated: May 28, 2024

Record last verified: 2024-05