# Effects of high-intensity interval inspiratory muscle training on diaphragm function and quality of life among tracheostomized patients: study protocol for a randomized controlled trial

## TL;DR

This study tests if high-intensity breathing exercises improve lung function and quality of life in patients with tracheostomies.

## Contribution

This is the first randomized controlled trial evaluating high-intensity interval inspiratory muscle training in tracheostomized patients.

## Key findings

- HI-IMT may improve diaphragm function and airway clearance in tracheostomized patients.
- The study will assess safety and effectiveness of HI-IMT on quality of life and decannulation rates.

## Abstract

Patients who undergo tracheostomy often experience respiratory muscle dysfunction and reduced airway clearance capacity, leading to reduced quality of life. While inspiratory muscle training (IMT) is effective at improving respiratory outcomes among mechanically ventilated patients, evidence about its clinical utility and safety, especially in tracheostomized populations, is limited. Moreover, the optimal IMT protocol for this patient cohort remains undefined. The aim of this study is to evaluate the effects of high-intensity interval inspiratory muscle training (HI-IMT) on diaphragmatic function, airway clearance capacity, anxiety levels, decannulation rates, quality of life, and safety outcomes among tracheostomy patients.

This is a single-center, single-blind, randomized controlled trial. Seventy tracheostomized patients (aged 40–70 years, with tracheostomy for 1–3 months) will be randomly assigned to either the HI-IMT group or the control group. The HI-IMT group will receive IMT at 50% of the maximal inspiratory pressure (MIP), 30 breaths/day, 5 days/week for 2 weeks. The control group will receive sham training, which will involve performing the same breathing cycles without any applied resistance. Both groups will receive standard care, including pharmacological therapy, rehabilitative nursing, and basic rehabilitation exercises. Diaphragmatic function, airway clearance ability, anxiety levels, and quality of life will be assessed using the MIP% predicted (primary outcome) and peak inspiratory flow (PIF), the Semi-Quantitative Cough Strength Score (SCSS), the standardized Zung Self-Rating Anxiety Scale (SAS), and the Tracheostomy-Specific Quality of Life (TQOL) scale. Additionally, decannulation rates and adverse events will be systematically recorded throughout the study period. Data will be analyzed using parametric or non-parametric tests for unadjusted between-group comparisons. All analyses will adhere to the intention-to-treat principle, with a p-value < 0.05 set for statistical significance.

This study is expected to provide valuable evidence about the efficacy and safety of HI-IMT in improving diaphragmatic function and overall outcomes among tracheostomized patients. These findings may contribute to the development of standardized respiratory rehabilitation protocols tailored to this patient population.

Chinese Clinical Trial, ChiCTR2500099091. Registered on 18 March 2025. https://www.chictr.org.cn/bin/project/edit?pid=265948.

The online version contains supplementary material available at 10.1186/s13063-025-09334-3.