Investigating the effect of using the inspiratory muscle training device (IMT) on the thickness and excursion of the diaphragm of COPD patients undergoing lung rehabilitation

Investigating the effect of using the inspiratory muscle training device (IMT) on the thickness and excursion of the diaphragm of COPD patients undergoing lung rehabilitation

A controlled, single-blind, randomized, phase 3 clinical trial with parallel groups on 22 patients, using a random number table for randomization.

Two groups of patients hospitalized in the Pulmonary Rehabilitation Department of Masih Hospital perform rehabilitation exercises, with the difference that in the intervention group, patients also use the IMT device. The radiologist who performs and evaluates the patients' ultrasound is blind.

Inclusion criteria included age over 18 years, diagnosis of COPD based on GOLD, literacy, and exclusion criteria included hemoptysis, embolism, lung cancer, pneumothorax, acute cardiovascular problems, diaphragmatic paralysis, severe shortness of breath preventing testing, patient unwillingness to continue participating in the research project, and not having a smartphone.

In the intervention group, patients perform daily pulmonary rehabilitation exercises along with aerobic exercise during 2 weeks of hospitalization. Patients use the IMT device. Patients continue the rehabilitation process at home as remote rehabilitation with the IMT device (for 6 weeks). In the control group, patients perform daily breathing exercises and stretching exercises along with aerobic exercise during 2 weeks of hospitalization. Then they continue their rehabilitation program at home for 6 weeks.

Exercise capacity, dyspnea, health-related quality of life, sit to stand test, S-index derived from IMT, diaphragm excursion and thickness

Randomization method: Simple, Randomization unit: Individual, Randomization tool: Random number table. Simple randomization method is used for randomization with the help of a random number table. For this purpose, two groups are named A and B. We choose one of the rows of the random number table at will and the numbers of each row will be between 0 and 9. We assign the numbers 0-4 to treatment A and the numbers 5-9 to treatment B.

Ultrasound scans of patients are performed by an experienced radiologist blind to the patient's other tests (on two occasions before the start of rehabilitation and at the end of the rehabilitation period).