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

November 23, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: 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
Through study completion, an average of 1 year
Muscle strength
Time Frame: 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
Through study completion, an average of 1 year
Muscle mass
Time Frame: 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
Through study completion, an average of 1 year
Respiratory muscle strength
Time Frame: 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
Through study completion, an average of 1 year
Cough strength
Time Frame: 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
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty
Time Frame: 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
Through study completion, an average of 1 year
Muscle balance
Time Frame: 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
Through study completion, an average of 1 year
Pulmonary Capacity
Time Frame: 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
Through study completion, an average of 1 year
Oxygen consumption
Time Frame: 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
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

Department of Health, Generalitat de Catalunya

Investigators

  • Principal Investigator: Bernat Planas Pascual, PT, MSc, Hospital Universitari Vall d'Hebron Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2019

Primary Completion (Anticipated)

August 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

January 17, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 23, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PR(AG)49-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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