Implementation of an Early Rehabilitation Program for the Patient With Lung Transplantation: From the ICU to Home.
NCT ID: NCT04244734
Last Updated: 2020-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
85 participants
INTERVENTIONAL
2019-05-23
2021-08-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
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)
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).
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)
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age criteria (From 18 to 70 years old).
* Start the rehabilitation program between the first 15 days after lung transplantation.
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Department of Health, Generalitat de Catalunya
OTHER_GOV
Hospital Universitari Vall d'Hebron Research Institute
OTHER
Responsible Party
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Principal Investigators
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Bernat Planas Pascual, PT, MSc
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Vall d'Hebron Research Institute
Locations
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Hospital Universitari Vall d'Hebron Research Institute
Barcelona, , Spain
Countries
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References
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Other Identifiers
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PR(AG)49-2019
Identifier Type: -
Identifier Source: org_study_id