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IRCT20230214057418N1 IRCT 2023-04-14 Mashhad University of Medical Sciences The effect of breathing training on lung function and extubation The effect of respiratory muscle exercises on pulmonary functional indices and successful extubation in patients hospitalized in the intensive care unit." 2023-05-10 anticipated 60 Complete https://irct.ir/trial/69059 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples meeting the inclusion criteria will be selected, and then permuted blocks of size 4 and 2 will be generated using Stata software version 17 by a statistician. To conceal the allocation of each block, they will be placed in a packet, Blinding description: The method of closed envelopes is used to allocate patients to groups. In this way, the generated random sequences are kept in closed envelopes. When a patient with inclusion criteria is found, the envelope is opened to identify his group. The outcome assessor and the statistics professor will also be unaware of this allocation. N/A Weakness of respiratory muscles in patients under mechanical ventilation.. Intervention 1: Control group: Control group: Routine exercises include chest physiotherapy (Vibration & Percussion, etc.) in the form of creating passive movement in the organs, compression and percussion in the chest, compressive stretching and vibration on the chest and changing the position, which is done by the physiotherapist. It is performed once a day for an average of 15 minutes, the intensity of which will vary based on the patient's cooperation and vital signs. Intervention 2: Intervention group: Intervention group: in the test group, in addition to physical therapy routine exercises, inspiratory and expiratory muscle strengthening exercises will be added by the Threshold IMT/PEP device that is connected to the end of the tracheal tube. Respiratory muscle exercises twice a day for one week include: inspiratory muscle exercises under the supervision of the researcher in 5 sets of 10 breaths with an intensity of 40% of PImax and expiratory exercises with PEP: 7 cm H2O for half an hour. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mohammad Kazemi
Number 41, Shahid Rajabi 6 , North Tabarsi 10
Mashhad Iran (Islamic Republic of) 9149843112 +98 51 3211 9640 KazemiM4001@mums.ac.ir Mashhad University of Medical Sciences scientific Razieh Froutan
University Street, Mashhad
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 froutanr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) be under mechanical ventilation for more than 48 hours GCS ≥ 13 PI max ≤ -20 cmH2O PaO2>60 PaO2/FiO2 ≥ 200 SPO2>90 TV > 5 ml/kg RR<35 RSBI < 105 lit/min no fever stable in hemodynamic status age between 18-80 years old 18 years 80 years Both A history of neuromuscular disease that may affect respiratory muscle function. Z99.11 Dependence on respirator [ventilator] status Treatment - Devices Treatment - Devices Control group: Control group: Routine exercises include chest physiotherapy (Vibration & Percussion, etc.) in the form of creating passive movement in the organs, compression and percussion in the chest, compressive stretching and vibration on the chest and changing the position, which is done by the physiotherapist. It is performed once a day for an average of 15 minutes, the intensity of which will vary based on the patient's cooperation and vital signs. Intervention group: Intervention group: in the test group, in addition to physical therapy routine exercises, inspiratory and expiratory muscle strengthening exercises will be added by the Threshold IMT/PEP device that is connected to the end of the tracheal tube. Respiratory muscle exercises twice a day for one week include: inspiratory muscle exercises under the supervision of the researcher in 5 sets of 10 breaths with an intensity of 40% of PImax and expiratory exercises with PEP: 7 cm H2O for half an hour. Pulmonary functional indices. Timepoint: Every day before and after the intervention. Method of measurement: Ventilator. Successful extubation. Timepoint: 48 hours after extubation. Method of measurement: Clinical symptoms. Mashhad University of Medical Sciences Approved 2023-03-14 Ethics committee of Mashhad University of Medical Sciences Daneshgah Ave, Ghoeishi Building Mashhad Razavi Khorasan Iran (Islamic Republic of)