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

Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04244734
• Other study ID #: PR(AG)49-2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: August 2021

Study information

• Verified date: November 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Transplant
• Rehabilitation

Intervention

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)
• 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)

Locations

Country	Name	City	State
Spain	Hospital Universitari Vall d'Hebron Research Institute	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Department of Health, Generalitat de Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (22)

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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