Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.

Conditions
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Lung Transplant, Rehabilitation

Intervention / Treatment
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* Other: Usual care treatment
* Other: New Treatment Protocol-MotoMED®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>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 (initially at 40% load from results in MIP). | Other: Usual care treatment<br>* All evaluations are the same in both groups: Baseline evaluation ICU admission (If patient hemodynamically stable initiates physiotherapy treatment within the first 15 days after surgery). Treatment:A daily session from Monday to Friday of 40 minutes according to patient functional status: Passive or active-assisted or active mobilizations, muscle enhancement, respiratory physiotherapy and inspiratory muscle training at 40% of the PIM value. 2nd evaluation when patient has a RASS -1/0 score: 3rd evaluation when ICU discharge. Treatment ward: A 60-minute daily session according to patient functional status in the gym (physiotherapy area in hospital): Cycloergometer, muscle enhancement, respiratory physiotherapy and inspiratory muscle training. 4th evaluation when hospital discharge 5th evaluation (1 month after discharge) 6th evaluation (4 months after discharge) 7th evaluation (1 year after surgery)<br>* Other names: usual care;|
| Experimental: Group 2<br>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 (initially at 60% load from results in MIP). | Other: New Treatment Protocol-MotoMED®<br>* Baseline evaluation ICU admission (If patient hemodynamically stable initiates physiotherapy treatment within the first 15 days after surgery). Treatment: A daily session from Monday to Friday of 40 minutes (5 minutes of warm-up, 30 of training and 5 of cooling). Combined quadriceps / biceps femoris electrotherapy: at 200-350μs intensity. Respiratory physiotherapy with the objectives: Airway permeabilization and inspiratory muscle training at 60% of the PIM value. 2nd evaluation when patient has a RASS -1/0 score: 3rd evaluation when ICU discharge. Treatment ward: A 60-minute daily session according to patient functional status in the gym (physiotherapy area in hospital): Cycloergometer, muscle enhancement, respiratory physiotherapy and inspiratory muscle training. 4th evaluation when hospital discharge 5th evaluation (1 month after discharge) 6th evaluation (4 months after discharge) 7th evaluation (1 year after surgery)<br>* Other names: MotoMED + NEMS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity | Measured with 6MWT It will be measured in different moments: Baseline Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge | Through study completion, an average of 1 year | 
| Muscle strength | Measured with dynamometer It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge | Through study completion, an average of 1 year | 
| Muscle mass | Measured with bioimpedanciometry It will be measured in different moments: Baseline Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge | Through study completion, an average of 1 year | 
| Respiratory muscle strength | Measured with MIP and MEP It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge | Through study completion, an average of 1 year | 
| Cough strength | Measured with Peak Cough Flow It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frailty | Measured with the short physical performance battery test (SPPB test) SPPB (maximum 12 points) 7 points or less: Frailty 8 to 9 points: Pre-frailty More than 10 points: Not frailty It will be measured in different moments: Baseline Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge | Through study completion, an average of 1 year | 
| Muscle balance | Measured with the Medical Research Council sum score test It will be measured in different moments Baseline When patient awake in ICU (RASS -1/0) Hospital discharge After 1 month of discharge After 4 month of discharge 1 year after the discharge | Through study completion, an average of 1 year | 
| Pulmonary Capacity | Measured with a spirometer We will interpret the data obtained from forced spirometry to evaluate how our patient's pulmonary functions is developing after the surgery. Data collection: FEV1/FVC: It represents the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC).The result of this ratio is expressed as FEV1%. The normal value for the FEV1/FVC ratio is 70% (and 65% in persons older than age 65). It will be measured in different moments Baseline 1 year after the discharge | Through study completion, an average of 1 year | 
| Oxygen consumption | Measured with the Cardiopulmonary effort test It will be measured in different moments After 1 month of discharge After 4 month of discharge 1 year after the discharge | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung transplantation, rehabilitation, respiratory muscle training, early mobilisation, Neuromuscular electrostimulation, in-bed cycling