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IRCT20101107005123N4 IRCT 2024-02-25 Mashhad University of Medical Sciences Efficacy of using oscillatory-PEP device on pulmonary function based on spirometry indices in patient with cystic fibrosis Efficacy of using oscillatory-PEP device on pulmonary function based on spirometry indices in patient with cystic fibrosis (Randomized control trial) 2023-12-18 anticipated 90 Complete https://irct.ir/trial/73800 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method and description of each method: simple randomization Randomization Unit: Individual Randomization tool: table of random numbers Patients are divided into intervention and control groups based on a simple random allocation method (using a table of random numbers through a computer), and people are randomly assigned to one of the intervention and placebo groups, Blinding description: In this double-blind study, the evaluator and the analysts are unaware of each person participating in the study in the main intervention group (use of floater) or control (not using floater). For blinding, the assigned codes are written separately on separate sheets and placed inside separate envelopes, and the sheets are folded in such a way that the number written inside cannot be seen. After the visit of each patient who meets the entry criteria, an envelope is removed and according to the number written in it, the patient is placed in one of the two groups, A or B. N/A Cystic fibrosis. Intervention 1: Intervention group: In the group receiving physiotherapy with floater (intervention), in addition to 3 sessions of physiotherapy, 3 sessions of floater will be performed between morning and noon, between noon and evening and one session at the end of the night. Intervention 2: Control group: In the control group, there will be breathing physiotherapy in the traditional form by percussion and vibration method, which will be 3 times a day and each time for 15 minutes. Yes - There is a plan to make this available What will be shared: Individually nonidentifiable data of participants will be shared in this study. also, the protocol, results, and statistical analysis of the study will be published in the relevant articles. When: Access to data begins 6 months after publication of results. To whom: The unidentifiable personal data of the participants will be made available to other researchers at academic institutions. Conditions: The unidentifiable personal data of the participants can only be used for research. Where to obtain: Individually nonidentifiable information of participants can be obtained by sending an email to Dr. Saeedeh Talebi (TalebiS@mums.ac.ir) How to obtain: Other researchers in academic institutions can send their requests by email to Dr. Saeedeh Talebi. The data will be sent to them after consulting and approving the research team. Comments:
public Saeedeh Talebi
Ghaem hospital, Ahmad Abad St.
Mashhad Iran (Islamic Republic of) 9176756436 +98 51 3842 0718 talebis@mums.ac.ir Mashhad University of Medical Sciences scientific Saeedeh Talebi
No. 2.12, Taleghani 7., Ahmad Abad Street., Mashhad Town
Mashhad Iran (Islamic Republic of) 9176756436 +98 51 3842 0718 talebis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Cystic fibrosis patients who have been diagnosed based on clinical symptoms and sweat test and have referred to the clinic or office as an outpatient Entry age is above 5 years The percentage of oxygen saturation based on pulse oximetry should be greater than or equal to 90% at room temperature Be clinically stable Able to perform the spirometry maneuver and have a minimum FEV1 greater than or equal to 30% based on the normal population based on age, gender and height Informed consent has been obtained from the patients 5 years no limit Both Have evidence of severe complications of lung disease including severe hemoptysis or pneumothorax within the last 2 months Have an acute upper respiratory disease E84.9 Cystic fibrosis, unspecified Rehabilitation Rehabilitation Intervention group: In the group receiving physiotherapy with floater (intervention), in addition to 3 sessions of physiotherapy, 3 sessions of floater will be performed between morning and noon, between noon and evening and one session at the end of the night. Control group: In the control group, there will be breathing physiotherapy in the traditional form by percussion and vibration method, which will be 3 times a day and each time for 15 minutes. Forced expiratory volume1 (FEV1). Timepoint: At the beginning of the study and 4 weeks after the intervention. Method of measurement: CHESTGRAPH HI-105 spirometer device. Forced vital capacity (FVC). Timepoint: At the beginning of the study and 4 weeks after the intervention. Method of measurement: CHESTGRAPH HI-105 spirometer device. Forced expiratory flow 25–75 (FEF25-75%). Timepoint: At the beginning of the study and 4 weeks after the intervention. Method of measurement: CHESTGRAPH HI-105 spirometer device. Mashhad University of Medical Sciences Approved 2022-05-31 Research Ethics Committees of School of Medicine- Mashhad University of Medical Sciences Nutrition Department, School of Medicine, East door of Ferdowsi University, Azadi Sq. Mashhad Razavi Khorasan Iran (Islamic Republic of)