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 (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04244734

Collaborator

Department of Health, Generalitat de Catalunya (Other)

Enrollment

Location

Arms

26.3

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Transplant Rehabilitation	Other: Usual care treatment Other: New Treatment Protocol-MotoMED®	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 23, 2019

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 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 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) Other Names: usual care
Experimental: Group 2 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® 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) Other Names: MotoMED + NEMS

Arm

Intervention/Treatment

Active Comparator: Group 1

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

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)

Other Names:

usual care

Experimental: Group 2

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®

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)

Other Names:

MotoMED + NEMS

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.