Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-01-08 @ 11:06 AM
Study NCT ID:
NCT04244734
Status:
UNKNOWN
Last Update Posted:
2020-11-24
First Post:
2020-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Organization:
Study Overview
Official Title:
Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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: Following pulmonary transplantation (PT), peripheral and respiratory muscle weakness, and associated global malfunction are some of the limiting factors in rapid recovery. Effective early implantation pulmonary rehabilitation programs are currently lacking.
Objectives: To introduce an early rehabilitation program in the ICU after PT to see if there is an improvement in functionality, an increase in strength and muscle mass, an improvement in the strength of the respiratory muscles and a shorter hospitalization time in the ICU and in the ward.
Methodology: A single-blind randomized clinical trial will be performed to divide patients with PT into one experimental group and another control group. Prior to the PT, those patients between the ages of 18 and 70 will be recruited, to be admitted to the ICU of Vall Hebron University Hospital, and who have been prescribed pulmonary rehabilitation with onset in the first 15 days after the surgery. The control group receives regular treatment in the ICU, which includes muscle strengthening exercises, passive/assisted or active mobilizations, and respiratory physiotherapy with breathing muscle strengthening in a medium load. The experimental group receives a new early rehabilitation program based on a patient's in-bed cycling that allows controlled and adapted training to the patient's situation, along with coordinated exercise with neuromuscular electrostimulation and respiratory physiotherapy with breathing muscle strengthening in a high load. Improvement will be observed through functional scales (6MWT), muscle dynamometry, manual muscle test (MRC-SumScore), bioimpedanciometry, inspiratory and maximal expiratory pressures, spirometry, frailty and sarcopenia tests and a long-term Cardiopulmonary Exercise Testing.
Expected Outcomes: Patients who perform the experimental group are expected to have an early discharge from the ICU and a reduction of the total hospital admission. Is also expected that the experimental group will improve the functional capacity and muscular strength, and they will have a lower risk of fragility in long term. It is also expected that the patients in the experimental group will soon be able to normalize their oxygen consumption a year after lung transplantation.
Objectives: To introduce an early rehabilitation program in the ICU after PT to see if there is an improvement in functionality, an increase in strength and muscle mass, an improvement in the strength of the respiratory muscles and a shorter hospitalization time in the ICU and in the ward.
Methodology: A single-blind randomized clinical trial will be performed to divide patients with PT into one experimental group and another control group. Prior to the PT, those patients between the ages of 18 and 70 will be recruited, to be admitted to the ICU of Vall Hebron University Hospital, and who have been prescribed pulmonary rehabilitation with onset in the first 15 days after the surgery. The control group receives regular treatment in the ICU, which includes muscle strengthening exercises, passive/assisted or active mobilizations, and respiratory physiotherapy with breathing muscle strengthening in a medium load. The experimental group receives a new early rehabilitation program based on a patient's in-bed cycling that allows controlled and adapted training to the patient's situation, along with coordinated exercise with neuromuscular electrostimulation and respiratory physiotherapy with breathing muscle strengthening in a high load. Improvement will be observed through functional scales (6MWT), muscle dynamometry, manual muscle test (MRC-SumScore), bioimpedanciometry, inspiratory and maximal expiratory pressures, spirometry, frailty and sarcopenia tests and a long-term Cardiopulmonary Exercise Testing.
Expected Outcomes: Patients who perform the experimental group are expected to have an early discharge from the ICU and a reduction of the total hospital admission. Is also expected that the experimental group will improve the functional capacity and muscular strength, and they will have a lower risk of fragility in long term. It is also expected that the patients in the experimental group will soon be able to normalize their oxygen consumption a year after lung transplantation.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: