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.

To determine the effect of early initiation of inspiratory muscle training on pulmonary function in patients with acute asthma attacks.

A phase 2–3 randomized controlled clinical trial with parallel groups and a single-blind design will be conducted on 102 patients. Randomization will be performed using the Sealed Envelope website (sealedenvelope.com).

This randomized clinical trial will be conducted at Shahid Jalil Hospital, Yasuj, on patients with acute asthma. Participants will be randomly allocated using Sealed Envelope into intervention and control groups. The intervention group will receive 6 weeks of IMT, while the control group receives standard care. Pulmonary function and sleep quality will be assessed at baseline and at the end of the study. The study is single-blind, with blinded outcome assessors and data analysts.

Inclusion criteria: Patients with acute asthma attacks with at least three months since diagnosis, no long-term use of continuous positive airway pressure (CPAP) or similar positive pressure ventilation devices, and no history of stroke. Exclusion criteria: Presence of lung cancer or other end-stage malignancies.

In the intervention group, patients will undergo inspiratory muscle training using the IMT K5 POWERbreathe device for 6 weeks (two sessions per week). The intervention will begin 5–7 days after clinical stabilization. Training intensity will be individually set at 30% of baseline inspiratory pressure and adjusted progressively based on each patient’s tolerance. The control group will receive standard routine hospital care only. At the end of the intervention, all baseline assessments and questionnaires will be repeated in both groups.

Pulmonary functioy؛ Sleep Quality

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.

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.

After the completion of the study, all study data will be shared after being de-identified

The Commencement Of The Access Period Is 3 Months After The Publication Of The Results

The study data will be available to academic and scientific researchers working in medical sciences centers.

Individuals associated with the medical and therapeutic fields may utilize the data from this study to conduct new research.

Via official email to the corresponding author at: sajad.hassanzadeh@gmail.com.

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