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IRCT20210505051181N2 IRCT 2022-01-29 Iran University of Medical Sciences Evaluation of the effect of priority of chest physiotherapy and prone position in covid 19 The effect of priority of chest physiotherapy and prone position on respiratory indicators in patients with covid 19: Randomize clinical trial 2022-01-21 anticipated 30 Complete https://irct.ir/trial/57481 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: In this study, the limited randomization method of block randomization will be used. Blockage is usually used to balance the number of samples allocated to each of the studied groups. The size of all the blocks is equal and in this trial which includes 30 patients in 2 groups, we will have blocks with size of 6. Random allocation software is also used for randomization. In order to conceal allocation of participants to the groups, sequentially numbered, sealed, opaque envelopes (SNOSE) will be used, Blinding description: This study is a double blind study. Examiners of this study, who assess patients respiratory indicators, will be unaware of the randomization process and assignment of participants to each group and this will be done by someone else and thus bias is prevented. Patients also unware of how to group. It should be noted that the therapist is aware of how to group and the patient in each group. N/A Condition 1: COVID19, virus identified. Condition 2: COVID 19 virus not identified. Intervention 1: Intervention group 1: In this group in 6 sessions, chest physiotherapy will be performed once a day for 30 minutes. Chest physiotherapy procedures performed in this group are: 1- Percussion in which the physiotherapist with free wrist and hand in a cup and hollow position transmits energy to the peripheral airways by performing rhythmic clapping on the chest. 2- Vibration, in which a series of small oscillating movements are performed by the hands on the chest wall, while exhaling after performing a deep breath. 3- Diaphragmatic breathing in which the patient is required to have abdominal breathing. 4- Segmental breathing: In this method, the patient sits comfortably, the physiotherapist places his hand on both sides of the chest in different lobes of the patient's lungs and asks the person to guide the air under the therapist's hand while breathing so that the therapist's hand movement can be seen and other parts of the lungs are relaxed. After performing chest physiotherapy techniques, patients will be in a prone position for 3 hours on the same day. Intervention 2: Intervention group 2: In 6 sessions, patients are first placed in a prone position for 3 hours a day. Then on the same day, chest physiotherapy will be performed for 30 minutes. Same as intervention group1, chest physiotherapy procedures performed in this group are: 1- Percussion in which the physiotherapist with free wrist and hand in a cup and hollow position transmits energy to the peripheral airways by performing rhythmic clapping on the chest. 2- Vibration, in which a series of small oscillating movements are performed by the hands on the chest wall, while exhaling after performing a deep breath. 3- Diaphragmatic breathing in which the patient is required to have abdominal breathing. 4- Segmental breathing: In this method, the patient sits comfortably, the physiotherapist places his hand on both sides of the chest in different lobes of the patient's lungs and asks the person to guide the air under the therapist's hand while breathing so that the therapist's hand movement can be seen and other parts of the lungs are relaxed. Yes - There is a plan to make this available What will be shared: Data can be shared after making participants unrecognizable. When: Start access period 6 months after the results publication To whom: People in medicine and rehabilitation field Conditions: Performing any analysis to any data resulted form this study will be allowed only with the permission of corresponding author. Where to obtain: Email the researcher- Ali Rezaee- alireza722012@yahoo.com How to obtain: 6 months after the publication of the results, information will be given to the applicant within a week by emailing the researcher. Comments:
public Ali Rezaee Chamanabad
Unit 8, Arman Building, 3rd East Alley, Bustan Alley, Golestan St., Central Janatabad St.
Tehran Iran (Islamic Republic of) 1475654343 +98 21 4604 8909 alireza722012@yahoo.com Iran University of Medical Sciences scientific Mehrnaz Kajbafvala
Shahid Shahid Dastgerdi (Zafar) Ave, Aliasghar Children Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6688 kajbafvala.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) People who have been hospitalized for Covid 19 and are fully conscious Covid 19 affection have been confirmed by laboratory findings ( CT scan, PCR test and serology test) and infectious disease specialist and the patient does not need mechanical ventilation Based on the classification of Covid 19 phases in radiological findings, patient should be in the progressive or acute phase Patients should be the same in terms of medication type and dose (Corticosteroids and Remdesivir) 35 years 75 years Both Patients who need mechanical ventilation due to the severe progression of the disease Patients with neurological disorders Patients with history of chest or abdominal surgery in the last 4 months Patients with blood coagulation disorders Patients with active bleeding in the chest area or rib fractures U07.1 U07. 2 COVID19, virus identified COVID 19 virus not identified Rehabilitation Rehabilitation Intervention group 1: In this group in 6 sessions, chest physiotherapy will be performed once a day for 30 minutes. Chest physiotherapy procedures performed in this group are: 1- Percussion in which the physiotherapist with free wrist and hand in a cup and hollow position transmits energy to the peripheral airways by performing rhythmic clapping on the chest. 2- Vibration, in which a series of small oscillating movements are performed by the hands on the chest wall, while exhaling after performing a deep breath. 3- Diaphragmatic breathing in which the patient is required to have abdominal breathing. 4- Segmental breathing: In this method, the patient sits comfortably, the physiotherapist places his hand on both sides of the chest in different lobes of the patient's lungs and asks the person to guide the air under the therapist's hand while breathing so that the therapist's hand movement can be seen and other parts of the lungs are relaxed. After performing chest physiotherapy techniques, patients will be in a prone position for 3 hours on the same day. Intervention group 2: In 6 sessions, patients are first placed in a prone position for 3 hours a day. Then on the same day, chest physiotherapy will be performed for 30 minutes. Same as intervention group1, chest physiotherapy procedures performed in this group are: 1- Percussion in which the physiotherapist with free wrist and hand in a cup and hollow position transmits energy to the peripheral airways by performing rhythmic clapping on the chest. 2- Vibration, in which a series of small oscillating movements are performed by the hands on the chest wall, while exhaling after performing a deep breath. 3- Diaphragmatic breathing in which the patient is required to have abdominal breathing. 4- Segmental breathing: In this method, the patient sits comfortably, the physiotherapist places his hand on both sides of the chest in different lobes of the patient's lungs and asks the person to guide the air under the therapist's hand while breathing so that the therapist's hand movement can be seen and other parts of the lungs are relaxed. Oxygen saturation percentage. Timepoint: before beginning physiotherapy interventions and after completion 6 physiotherapy sections corresponding to each group. Method of measurement: pulse oximetry. Partial pressure of oxygen ( Pao2). Timepoint: before beginning physiotherapy interventions and after completion 6 physiotherapy sections corresponding to each group. Method of measurement: arterial blood gases (ABG). Forced vital capacity (FVC). Timepoint: before beginning physiotherapy interventions and after completion 6 physiotherapy sections corresponding to each group. Method of measurement: spirometer. Forced expiratory volume in the first second (FEV1 ). Timepoint: before beginning physiotherapy interventions and after completion 6 physiotherapy sections corresponding to each group. Method of measurement: spirometer. Fraction of inspired oxygen (Fio2). Timepoint: before beginning physiotherapy interventions and after completion 6 physiotherapy sections corresponding to each group. Method of measurement: oxygen meter. Partial pressure of oxygen to fraction of inspired oxygen ratio (Pao2/Fio2). Timepoint: before beginning physiotherapy interventions and after completion 6 physiotherapy sections corresponding to each group. Method of measurement: mathematical calculation. Forced expiratory volume in the first second to forced vital capacity ratio (FEV1/FVC). Timepoint: before beginning physiotherapy interventions and after completion 6 physiotherapy sections corresponding to each group. Method of measurement: mathematical calculation. Iran University of Medical Sciences Approved 2021-10-16 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)