G. Mitsiou_SPIRIT_checklist.pdf “The effect of inspiratory muscle training on dysfunctional breathing and functional ability in patients with chronic heart failure. A study protocol for a randomized controlled trial”

Cardiac rehabilitation is considered standard care for patients with chronic heart failure (CHF) to improve cardiopulmonary symptoms. Inspiratory muscle training (IMT) in conjunction with exercise training programs is an effective complementary treatment for respiratory pattern retraining, improves dyspnea, pulmonary ventilation, and overall exercise capacity in patients with CHF. Only a limited number of studies have examined the effects of IMT alone in respiratory function in heart failure. Diaphragmatic function has been also poorly investigated. The aim of the study is to investigate the effect of IMT on dysfunctional breathing, diaphragmatic thickness and functional ability. Secondary objective is to investigate the effect of IMT on maximal inspiratory pressure (MIP), dyspnea, and quality of life in patients with CHF. This study includes a four-week intervention period. A total of 22 outpatients with CHF will be randomly assigned to two groups with a 1:1 ratio. The intervention group will be trained with IMT in conjunction with DB and the control group will receive only DB. There will be two measurements of the outcomes (0 and 4 weeks).The Ethics Committee of UNIWA approved the present study under protocol no. 51604/04-06-2025. The ethics approval was obtained on 4th June 2025 from the University of West Attica. The study fully adheres to the Helsinki Declaration's "Ethical Principles of Medical Research Involving Human Subjects." Any protocol modifications will be promptly disclosed to the Ethics Committee. The trial is registered at the Clinical trials.gov database with identification number NCT07104357.The results will contribute to the holistic management of patients with CHF by integrating respiratory physiotherapy into their rehabilitation, enabling them to control their breathing, self-manage dyspnea, and improve quality of life.