Inspiratory Muscle Training During Hemodialysis

Individuals receiving regular hemodialysis may experience reduced inspiratory muscle strength, impaired lung function, dyspnea, reduced functional capacity, decreased daily physical activity, and changes in body composition. This single-center, open-label, randomized controlled study will evaluate the effect of intradialytic inspiratory muscle training on inspiratory muscle strength and related clinical and functional outcomes. All participants will first complete a 12-week observational period without study-protocolized inspiratory muscle training. Following the T0 assessment, participants will be randomly assigned in a 1:1 ratio to inspiratory muscle training plus usual care or usual care alone for 12 weeks. Participants assigned to inspiratory muscle training will perform training during hemodialysis using the POWERbreathe KH2 device. After the Week 12 assessment, participants initially assigned to inspiratory muscle training will undergo a second independent 1:1 randomization to either weekly maintenance inspiratory muscle training or discontinuation of study-protocolized training for 12 weeks. Participants initially assigned to usual care will continue usual care. Following the Week 24 assessment, no participant will receive study-protocolized inspiratory muscle training for 12 weeks. Follow-up assessments will be conducted through Week 52 after the initial randomization. The primary comparison is between inspiratory muscle training plus usual care and usual care alone at Week 12. Analyses of the second randomization and later follow-up assessments are exploratory.