Clinical trial NCT04244734: Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.
Official title: Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Transplant
Rehabilitation
Keywords: lung transplantation
rehabilitation
respiratory muscle training
early mobilisation
Neuromuscular electrostimulation
in-bed cycling
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
First posted: 2020-01-28
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral lung transplantation.
* Age criteria (From 18 to 70 years old).
* Start the rehabilitation program between the first 15 days after lung transplantation.

Exclusion Criteria:

* Do not meet inclusion criteria.
* Fulfill some criterion of absolute contraindication for the use of electrostimulation in the lower extremities (pacemaker, pregnancy or unstable fracture that requires absolute rest and immobilization.
* Cognitive or psychiatric alteration that does not allow you to participate in the project.
* Not wanting to participate in the study.

Primary outcomes:
measure: Exercise Capacity
timeFrame: Through study completion, an average of 1 year
measure: Muscle strength
timeFrame: Through study completion, an average of 1 year
measure: Muscle mass
timeFrame: Through study completion, an average of 1 year
measure: Respiratory muscle strength
timeFrame: Through study completion, an average of 1 year
measure: Cough strength
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Frailty
timeFrame: Through study completion, an average of 1 year
measure: Muscle balance
timeFrame: Through study completion, an average of 1 year
measure: Pulmonary Capacity
timeFrame: Through study completion, an average of 1 year
measure: Oxygen consumption
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron Research Institute
Study officials:
affiliation: Hospital Universitari Vall d'Hebron Research Institute
name: Bernat Planas Pascual, PT, MSc
role: PRINCIPAL_INVESTIGATOR
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