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

Not Applicable

• Conditions: Rehabilitation; Lung Transplant
• Interventions: Other: Usual care treatment; Other: New Treatment Protocol-MotoMED®

• Registration Number: NCT04244734
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-28
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-23
• Last Update Posted: 2020-11-24
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Usual care treatment	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).
Group 2	New Treatment Protocol-MotoMED®	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).

Primary Outcome Measures

Name	Time	Method
Muscle mass	Through study completion, an average of 1 year	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
Respiratory muscle strength	Through study completion, an average of 1 year	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
Cough strength	Through study completion, an average of 1 year	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
Exercise Capacity	Through study completion, an average of 1 year	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
Muscle strength	Through study completion, an average of 1 year	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

Secondary Outcome Measures

Name	Time	Method
Frailty	Through study completion, an average of 1 year	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
Muscle balance	Through study completion, an average of 1 year	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
Pulmonary Capacity	Through study completion, an average of 1 year	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
Oxygen consumption	Through study completion, an average of 1 year	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

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron Research Institute; 🇪🇸 Barcelona, Spain