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IRCT20260423069136N1 IRCT 2026-05-13 Yasouj University of Medical Sciences Early Inspiratory Muscle Training (IMT) on Lung Function and Sleep in Acute Asthma The impact of early initiation of inspiratory muscle training (IMT) on pulmonary function and sleep quality in patients with asthma attack: a randomized clinical trial study. 2026-06-05 anticipated 102 Recruiting https://irct.ir/trial/89870 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated using block randomization to ensure balanced group sizes. Group A is the intervention, and Group B is the control. The allocation sequence will be generated randomly using the Sealed Envelope website, and participants will be assigned accordingly. To minimize predictability, variable block sizes (2, 4, 6, and 8) will be used, Blinding description: This study is designed as a single-blind trial. Participants will be aware of the intervention they receive; however, the outcome assessor and the data analyst will be blinded to group allocation and the type of intervention administered. This approach is intended to reduce assessment and analytical bias and to enhance the validity of the study findings, while full blinding of participants is not feasible due to the nature of the intervention. 2-3 Asthma Attack. Intervention 1: Intervention group: Patients will receive inspiratory muscle training (IMT) using the IMT K5 POWERbreathe device for 6 weeks, with two sessions per week. Training intensity will initially be set at 30% of each patient’s baseline inspiratory pressure and progressively increased according to tolerance. Intervention 2: Control group: Patients will receive standard routine care without IMT intervention. Yes - There is a plan to make this available What will be shared: After the completion of the study, all study data will be shared after being de-identified When: The Commencement Of The Access Period Is 3 Months After The Publication Of The Results To whom: The study data will be available to academic and scientific researchers working in medical sciences centers. Conditions: Individuals associated with the medical and therapeutic fields may utilize the data from this study to conduct new research. Where to obtain: Via official email to the corresponding author at: sajad.hassanzadeh@gmail.com. How to obtain: The applicant must submit their formal request via the organization's email to the responsible author's email address. The accountable author will provide the information to the applicant within a maximum of two weeks after they confirm the information Comments:
public Sajjad Hassan-zadeh
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
Yasuj Iran (Islamic Republic of) 7591875111 +98 74 3323 5153 sajad.hassanzadeh@gmail.com Yasouj University of Medical Sciences scientific Sajjad Hassan-zadeh
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
Yasuj Iran (Islamic Republic of) 7591875111 +98 74 3323 5153 sajad.hassanzadeh@gmail.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Asthma attack exacerbation No long-term use of continuous positive airway pressure (CPAP) 18 years 65 years Both Presence of lung cancer or other end-stage malignancies J45.901 Unspecified asthma with (acute) exacerbation Treatment - Devices Treatment - Other Intervention group: Patients will receive inspiratory muscle training (IMT) using the IMT K5 POWERbreathe device for 6 weeks, with two sessions per week. Training intensity will initially be set at 30% of each patient’s baseline inspiratory pressure and progressively increased according to tolerance. Control group: Patients will receive standard routine care without IMT intervention. Pulmonary function. Timepoint: Before and immediately after the end of the intervention. Method of measurement: Pulmonary spirometry (using the Spiromax device manufactured by Teb Tasvir Company). Sleep Quality. Timepoint: Before and immediately after the end of the intervention. Method of measurement: Use of the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Dyspnea severity. Timepoint: Before and immediately after the end of the intervention. Method of measurement: Rating of Perceived Exertion ( RPE). Yasouj University of Medical Sciences Approved 2025-11-19 Ethics committee of Yasuj University of Medical Sciences Daneshgah St., Motahari Blvd., Jahad Town Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)