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IRCT20240630062284N2 IRCT 2025-12-06 Shahre-kord University of Medical Sciences Effects of active cycle breathing technique on health status, sleep quality, and health-related quality of life of people with chronic obstructive pulmonary disease Effects of active cycle breathing technique on health status, sleep quality, and health-related quality of life of people with chronic obstructive pulmonary disease 2025-12-22 anticipated 70 Complete https://irct.ir/trial/85952 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of assigning samples to groups will be in the form of random blocks with different numbers without permutation. For this purpose, first the letter A is considered for the control group and the letter B for the experimental group, and different states of the two groups will be written on the card, and each will be placed in a sealed and opaque envelope. To cover the assignment, blocks with different numbers will be used, that is, blocks of 6 and 2 will be included in the blocks. The block of 6 can be a combination of ABBABA and ... The block of 2 can also include AB, BA. These envelopes are placed in a box and the researcher will not know which group the units under study will be in until the card is selected. Before facing the research units, the ward nurse (unaware of the study and the groups) will determine which group the patients who will enter the study will be in, respectively, by removing one of the envelopes from the box. This process will continue until all the cards are removed from the box, and the cards will be returned to the box again, and this random selection will be repeated until the desired sample size is provided. N/A Chronic obstructive pulmonary disease. Intervention 1: Intervention group: Perform the active cycle breathing technique independently and without supervision, twice a day (morning and evening), each time for 15 to 20 minutes (preferably before meals or 1 hour after) at home for 3 months. It includes rest periods between other parts of this cycle and continues until the person feels ready to perform other parts of the cycle or start a new cycle. By relaxing his shoulders and using the lower parts of the chest, the person tries to perform diaphragmatic breathing at a natural depth and speed. 2- Thoracic Expansion Exercises (TEE): In this stage, by increasing lung volume, air flow and clearing secretions from narrow airways and air diffusion in healthy lung parts are improved. To do this, the patient holds the air for 2 to 3 seconds by taking a deep and active breath and then exhales the air slowly and completely with a passive exhalation. This stage is performed following the BC stage and is repeated up to 3 times. 3- Forced expiratory technique (FET): This stage is a combination of one or two forced exhalations (huffs) along with the (BC) stage. By suddenly contracting the respiratory and abdominal muscles and huffing or coughing, the speed of air exiting the small airways increases and helps clear secretions. Intervention 2: Control group: Routine treatment and care methods will be used, and the researcher will not have any role in providing this training and care to this group. Yes - There is a plan to make this available What will be shared: Biographical data such as age and gender are essential for better presentation of research results, and since this data is anonymous, there is no reason not to publish it. When: Due to the anonymity and coding of the data, they will be available after the study is completed. To whom: This data will be accessible to various health professionals and researchers. Conditions: No analysis of this data is permitted and it will only be used for comparison with and citation of results from other studies Where to obtain: The download of the resulting article will be done according to the policy of the journal that publishes it. Therefore, the use of biographical data tables and other sections of the journal is possible after downloading. The email address of the responsible author included in the article will be available for communication with other authors and for guidance. How to obtain: For this purpose, the applicant can contact the office of the journal that published the article, the corresponding author, and the Vice President for Research of Shahrekord University of Medical Sciences. The duration of access depends on the policy of the journal and the Vice President for Research of the university, but the corresponding author will respond to the request of colleagues within a week. Comments:
public Komeil Zamani
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3334 9509 komeilza50@gmail.com Shahre-kord University of Medical Sciences scientific Jaefar Moghaddasi
Deputy of Research and Technology, Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) ۸۸۱۵۷۱۳۴۷۱ +98 38 3334 9509 jaefar_moghaddasi@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Participants complete written consent to participate in the study. The age range of patients with chronic obstructive pulmonary disease is 20 to 70 years. The participants' disease was diagnosed by pulmonology specialists and confirmed based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, which are as follows: • Having symptoms of shortness of breath, cough, and increased sputum production or a history of exposure to risk factors • The ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) should be less than 0.7 (FEV1/FVC ratio < 70%). 20 years 70 years Both People with physical and mental problems that interfere with the learning process. People with severe respiratory problems and respiratory failure that lead to intolerance to the breathing technique J44 Other chronic obstructive pulmonary disease Rehabilitation N/A Intervention group: Perform the active cycle breathing technique independently and without supervision, twice a day (morning and evening), each time for 15 to 20 minutes (preferably before meals or 1 hour after) at home for 3 months. It includes rest periods between other parts of this cycle and continues until the person feels ready to perform other parts of the cycle or start a new cycle. By relaxing his shoulders and using the lower parts of the chest, the person tries to perform diaphragmatic breathing at a natural depth and speed. 2- Thoracic Expansion Exercises (TEE): In this stage, by increasing lung volume, air flow and clearing secretions from narrow airways and air diffusion in healthy lung parts are improved. To do this, the patient holds the air for 2 to 3 seconds by taking a deep and active breath and then exhales the air slowly and completely with a passive exhalation. This stage is performed following the BC stage and is repeated up to 3 times. 3- Forced expiratory technique (FET): This stage is a combination of one or two forced exhalations (huffs) along with the (BC) stage. By suddenly contracting the respiratory and abdominal muscles and huffing or coughing, the speed of air exiting the small airways increases and helps clear secretions. Control group: Routine treatment and care methods will be used, and the researcher will not have any role in providing this training and care to this group. Health status. Timepoint: before the start of the intervention, one week and 3 months after the start of the intervention. Method of measurement: The COPD Assessment Test (CAT). Sleep quality. Timepoint: before the start of the intervention, one week and 3 months after the start of the intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Health-related quality of life. Timepoint: before the start of the intervention, one week and 3 months after the start of the intervention. Method of measurement: St George's Respiratory Questionnaire (SGRQ). Shahre-kord University of Medical Sciences Approved 2025-11-10 Ethics Committee of Shahrekord University of Medical Sciences Shahrekord, Kashani Blvd., University Headquarters Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)