Efficacy of using oscillatory-PEP device on pulmonary function based on spirometry indices in patient with cystic fibrosis (Randomized control trial)

Improving pulmonary function based on spirometry indicators in patients with cystic fibrosis using a vibrating positive pressure device (floater)

A controlled, parallel-group, double-blind, randomized clinical trial on 90 patients using web-based randomization.

90 patients will be selected based on the inclusion criteria among outpatients diagnosed with cystic fibrosis referring to Akbar hospital clinic in Mashhad. The evaluators and analysts are unaware of the allocation of the study groups. In a group (control), there will be breathing physiotherapy in the traditional form by percussion and vibration method, 3 times a day and each time for 15 minutes, and in the group receiving physiotherapy with a floater (intervention), in addition to 3 sessions of physiotherapy, 3 sessions Flutter will also be done and finally the lung function will be evaluated through spirometry.

Cystic fibrosis patients must have clinical symptoms of the disease and the sweat test indicates the disease. Also, patients should be able to perform the spirometry maneuver and FEV1 should be more than 30% of normal based on age, gender and height. Oxygen saturation should be greater than or equal to 90% and the disease should also be clinically stable. and exclussion criteria contain hemoptysis, pneumothorax, acute respiratory diseases.

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, and in the intervention group, in addition to receiving 3 times, 3 times of floater between morning and noon, between There will be a shift in the afternoon and evening and a shift at the end of the night.

expiratory fluctuating positive pressure, cystic fibrosis, lung function

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.

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.

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.

Access to data begins 6 months after publication of results.

The unidentifiable personal data of the participants will be made available to other researchers at academic institutions.

The unidentifiable personal data of the participants can only be used for research.

Individually nonidentifiable information of participants can be obtained by sending an email to Dr. Saeedeh Talebi (TalebiS@mums.ac.ir)

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.