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NOT YET RECRUITING
NCT06431139
NA

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

Sponsor: Christian Riberholt

View on ClinicalTrials.gov

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.

Official title: Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury - a Randomised Pilot and Feasibility Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

44

Start Date

2024-07-01

Completion Date

2026-01-31

Last Updated

2024-05-28

Healthy Volunteers

No

Interventions

OTHER

INSPIRE intervention protocol

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.