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IRCT20200611047727N7 IRCT 2025-06-23 Shahid Beheshti University of Medical Sciences The effect of using the inspiratory muscle training device (IMT) on the thickness and excursion of the diaphragm of COPD patients 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 2025-07-23 anticipated 221 Complete https://irct.ir/trial/84144 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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). 3 Chronic obstructive pulmonary disease. Intervention 1: Intervention group: Patients are hospitalized for 2 weeks and during this time they perform daily pulmonary rehabilitation exercises including diaphragmatic breathing, pursed lip breathing and respiratory stretching exercises along with aerobic exercise. In addition, patients use the IMT device. After 2 weeks, patients are discharged after receiving a home pulmonary rehabilitation program and exercise training. Patients continue their rehabilitation process at home as remote rehabilitation with the IMT device (for 6 weeks). To use the IMT device, the patient performs 30 repetitions in the morning and 30 repetitions in the afternoon every day, and the resistance of the device is gradually increased. At the end of 6 weeks, the patient returns to the hospital (rehabilitation department) and the desired evaluations will be performed. Intervention 2: Control group: Patients are hospitalized for 2 weeks and during this period, they perform daily breathing exercises including diaphragmatic breathing, pursed lip breathing, and respiratory stretching exercises for 20 minutes on the bed and under the direct supervision of a physiotherapist, along with aerobic exercise including at least 15 minutes of walking on a treadmill at a maximum speed equivalent to 80% of the six-minute walk test. After two weeks, patients are discharged after receiving a remote rehabilitation program and continue their rehabilitation program at home (under the supervision of the hospital rehabilitation team) for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Masoumeh Zoghali
Masih Daneshvari Hospital, Daarabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 masoumezoghali@gmail.com Shahid Beheshti University of Medical Sciences scientific Maryam Sadat Mirenayat
Masih Daneshvari Hospital, Daarabad
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2612 5050 MirenayaT_M@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Diagnosis of COPD based on GOLD 18 years no limit Both Hemoptysis embolism lung cancer pneumothorax acute cardiovascular problems diaphragmatic paralysis severe dyspnea preventing testing patient's unwillingness to continue participating in the research project J44 Other chronic obstructive pulmonary disease Treatment - Other Treatment - Other Intervention group: Patients are hospitalized for 2 weeks and during this time they perform daily pulmonary rehabilitation exercises including diaphragmatic breathing, pursed lip breathing and respiratory stretching exercises along with aerobic exercise. In addition, patients use the IMT device. After 2 weeks, patients are discharged after receiving a home pulmonary rehabilitation program and exercise training. Patients continue their rehabilitation process at home as remote rehabilitation with the IMT device (for 6 weeks). To use the IMT device, the patient performs 30 repetitions in the morning and 30 repetitions in the afternoon every day, and the resistance of the device is gradually increased. At the end of 6 weeks, the patient returns to the hospital (rehabilitation department) and the desired evaluations will be performed. Control group: Patients are hospitalized for 2 weeks and during this period, they perform daily breathing exercises including diaphragmatic breathing, pursed lip breathing, and respiratory stretching exercises for 20 minutes on the bed and under the direct supervision of a physiotherapist, along with aerobic exercise including at least 15 minutes of walking on a treadmill at a maximum speed equivalent to 80% of the six-minute walk test. After two weeks, patients are discharged after receiving a remote rehabilitation program and continue their rehabilitation program at home (under the supervision of the hospital rehabilitation team) for 6 weeks. Diaphragmatic excursion. Timepoint: At the beginning of hospitalization, after two weeks (at discharge), and also after 6 weeks of tele-rehabilitation. Method of measurement: Ultrasound. Diaphragmatic thickness. Timepoint: At the beginning of hospitalization, after two weeks (at discharge), and also after 6 weeks of tele-rehabilitation. Method of measurement: Ultrasound. Forced vital capacity (FVC). Timepoint: At the beginning of hospitalization, after two weeks (at discharge), and also after 6 weeks of tele-rehabilitation. Method of measurement: Spirometry. Forced expiratory volume in one second (FEV1). Timepoint: At the beginning of hospitalization, after two weeks (at discharge), and also after 6 weeks of tele-rehabilitation. Method of measurement: Spirometry. Predicted FVC. Timepoint: At the beginning of hospitalization, after two weeks (at discharge), and also after 6 weeks of tele-rehabilitation. Method of measurement: Spirometry. Six minute walk test distance. Timepoint: At the beginning of hospitalization, after two weeks (at discharge), and also after 6 weeks of tele-rehabilitation. Method of measurement: Six minute walk test. Dyspnea. Timepoint: At the beginning of hospitalization, after two weeks (at discharge), and also after 6 weeks of tele-rehabilitation. Method of measurement: Based on modified medical research council dyspnea scale questionnaire. Quality of life. Timepoint: At the beginning of hospitalization, after two weeks (at discharge), and also after 6 weeks of tele-rehabilitation. Method of measurement: Based on the St. George questionnaire. Shahid Beheshti University of Medical Sciences Approved 2025-05-27 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)