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IRCT20260104068543N1 IRCT 2026-01-30 Hamedan University of Medical Sciences ‏Effect of Breathing Exercises on Quality of Life in Patients with Asthma An Investigation into the Combined Effects of Diaphragmatic and Pursed-Lip Breathing Exercises on the Quality of Life of Patients with Asthma 2026-01-21 anticipated 60 Complete https://irct.ir/trial/88516 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To generate the random allocation sequence, restricted randomization with variable block sizes (2, 4, and 6) and a 1:1 allocation ratio was utilized to ensure the unpredictability of the assignments. The random sequence was generated by an independent statistician (who played no role in recruitment, intervention, or data analysis) using computer-generated random numbers in SPSS software version 26. The unit of randomization was individual, and eligible patients were assigned to two groups: intervention (A) and control (B). To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes (SNOSE) were used. The treatment group name was placed on a card inside each envelope. The envelopes were opened only after definitive patient registration and completion of baseline assessments by an independent administrative staff member (not involved in conducting the study), after which the contents were verified by the investigator. This rigorous protocol ensured that both investigators and patients remained completely blinded to the intervention type until the moment of envelope opening, eliminating any possibility of predicting or manipulating the group assignments. N/A Asthma. Intervention 1: Intervention group: The intervention involves performing breathing exercises, including diaphragmatic breathing and pursed-lip breathing. These exercises do not require special equipment, and patients perform them in a semi-sitting (relaxed) position. Initially, participants receive training in a single 90-minute session led by the researcher. In this session, the precise method of diaphragmatic breathing (inhaling through the nose with abdominal protrusion and exhaling gently through pursed lips) and pursed-lip breathing (inhaling through the nose and exhaling slowly and prolonged through the mouth with compressed lips) is taught. Following the training, patients perform the exercises once daily for a total duration of 20 minutes over a period of one month (4 weeks). The structure of each session consists of 5 minutes of diaphragmatic breathing followed by 15 minutes of pursed-lip breathing. All exercises are conducted under the direct supervision of the researcher to ensure correct execution. Intervention 2: Control group: Participants receive standard usual care without any additional breathing exercises. No - There is not a plan to make this available Justification or reason for not sharing IPD is No plan to share individual participant data is currently in place due to confidentiality concerns and the absence of a formal data sharing policy. No further information is available.
public Faezeh Saeedian
Hamadan University of Medical Sciences, Shahid Fahmideh St., Hamedan
Hamadan Iran (Islamic Republic of) 38698-65178 +98 81 3838 0535 Faezeh.saeediii96@gmail.com Hamedan University of Medical Sciences scientific Faezeh Saeedian
Hamadan University of Medical Sciences, Shahid Fahmideh St., Hamedan
Hamadan Iran (Islamic Republic of) 38698-65178 +98 81 3838 0535 Faezeh.saeediii96@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Confirmed diagnosis of asthma by a physician Age between 18 and 65 years Ability to perform breathing exercises Willingness to participate and signed informed consent 18 years 65 years Both Severe concurrent cardiac or pulmonary diseases Pregnancy J45 Asthma Behavior Behavior Intervention group: The intervention involves performing breathing exercises, including diaphragmatic breathing and pursed-lip breathing. These exercises do not require special equipment, and patients perform them in a semi-sitting (relaxed) position. Initially, participants receive training in a single 90-minute session led by the researcher. In this session, the precise method of diaphragmatic breathing (inhaling through the nose with abdominal protrusion and exhaling gently through pursed lips) and pursed-lip breathing (inhaling through the nose and exhaling slowly and prolonged through the mouth with compressed lips) is taught. Following the training, patients perform the exercises once daily for a total duration of 20 minutes over a period of one month (4 weeks). The structure of each session consists of 5 minutes of diaphragmatic breathing followed by 15 minutes of pursed-lip breathing. All exercises are conducted under the direct supervision of the researcher to ensure correct execution. Control group: Participants receive standard usual care without any additional breathing exercises. Quality of life . Timepoint: Measurement of quality of life at baseline (before starting the intervention), and at 4 and 8 weeks after beginning the breathing exercises. Method of measurement: Using the standard SF-36 questionnaire to assess quality of life. Quality of life related to respiratory health. Timepoint: Measurement of respiratory-related quality of life at baseline (before starting the intervention), and at 4 and 8 weeks after beginning the breathing exercises. Method of measurement: Using the standard Saint George’s Respiratory Questionnaire (SGRQ) to assess respiratory-related quality of life. Hamedan University of Medical Sciences Approved 2025-12-13 Ethics Committee of Hamedan University of Medical Sciences Hamadan University of Medical Sciences, Shahid Fahmideh St., Hamedan Hamedan Hamadan Iran (Islamic Republic of)