Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06405529
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-01-07
Brief Title:
Rehabilitation of Patients From the ICU to the Post-hospital Phase
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Rehabilitation of Patients Submitted to Mechanical Ventilation From the ICU to the Post-hospital Phase Blinded Randomized Controlled Clinical Trial With Economic and Multicenter Evaluation
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:
None
Brief Summary:
Introduction Advances in knowledge have contributed to the increase in the number of patients who survive prolonged hospitalization in an Intensive Care Unit ICU and among them critically ill patients who develop acute respiratory failure and need for mechanical ventilation These individuals have their mobility restricted to bed and may suffer from pulmonary and systemic complications such as ICU-Acquired Muscle Weakness which increases the chances of resulting in reduced functional capacity or death Early mobilization in the ICU has demonstrated benefits but still with a low level of evidence However the type and intensity of exercise still need to be better defined and previous protocols did not offer continuous monitoring from the ICU to the ward and subsequent outpatient rehabilitation for these patients which is considered a limitation in some studies
Objective To investigate the effects of an early and intensive hospital mobilization and post-hospital rehabilitation program on indicators of functionality inflammation cost-effectiveness and mortality in critically ill patients undergoing invasive mechanical ventilation
Methods This is a Blind Randomized Controlled Clinical Trial that will be conducted in the ICUs of the Hospital das Clinicas and the Emergency Unit of the Faculty of Medicine of Ribeirao Preto of the University of São Paulo Patients of both sexes over 21 years of age who have been under invasive mechanical ventilation for at least 24 hours will be recruited Patients will be randomized into the Intervention Group IG with 30 to 60 minutes of exercise per day and the Control Group CG with 10 minutes of exercise per day both with the same protocol and based on the ICU Mobility Scale - IMS with continuity in the ward After hospital discharge participants will be allocated to the Guidance Group GIor and GCor and the Outpatient Rehabilitation Group GIreab and GCreab with functional exercise capacity as the main outcome assessed by the six-minute walk test 6MWT Volunteers will be monitored one three and six months after hospital discharge The sample calculation was based on the results of the 6MWT with a power of 80 for the assessments carried out at the proposing institution n206 and with a power of 90 for the multicenter project n275 considering a sample loss of 30 The following will be evaluated clinical parameters severity indexes functionality lung function and mechanics functional exercise capacity mortality inflammatory markers energy expenditure activities of daily living quality of life muscle assessment adherence barriers and facilitators and cost-effectiveness
Objective To investigate the effects of an early and intensive hospital mobilization and post-hospital rehabilitation program on indicators of functionality inflammation cost-effectiveness and mortality in critically ill patients undergoing invasive mechanical ventilation
Methods This is a Blind Randomized Controlled Clinical Trial that will be conducted in the ICUs of the Hospital das Clinicas and the Emergency Unit of the Faculty of Medicine of Ribeirao Preto of the University of São Paulo Patients of both sexes over 21 years of age who have been under invasive mechanical ventilation for at least 24 hours will be recruited Patients will be randomized into the Intervention Group IG with 30 to 60 minutes of exercise per day and the Control Group CG with 10 minutes of exercise per day both with the same protocol and based on the ICU Mobility Scale - IMS with continuity in the ward After hospital discharge participants will be allocated to the Guidance Group GIor and GCor and the Outpatient Rehabilitation Group GIreab and GCreab with functional exercise capacity as the main outcome assessed by the six-minute walk test 6MWT Volunteers will be monitored one three and six months after hospital discharge The sample calculation was based on the results of the 6MWT with a power of 80 for the assessments carried out at the proposing institution n206 and with a power of 90 for the multicenter project n275 considering a sample loss of 30 The following will be evaluated clinical parameters severity indexes functionality lung function and mechanics functional exercise capacity mortality inflammatory markers energy expenditure activities of daily living quality of life muscle assessment adherence barriers and facilitators and cost-effectiveness
Detailed Description:
None
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