Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431139
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-05-07
Brief Title:
Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury
Sponsor:
Christian Riberholt
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Intensive Physical Exercise Versus Standard Exercise During Rehabilitation of Patients With Traumatic Brain Injury - a Randomised Pilot and Feasibility Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRE
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 participants 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
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 participants 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None