Inspiratory Muscle Training During Hemodialysis

Impact of Inspiratory Muscle Training on Functional Capacity, Lung Volumes, Electrical Activity and Inspiratory Muscle Strength in Hemodialysed Patients

This study will evaluate whether inspiratory muscle training performed during hemodialysis improves inspiratory muscle strength in adults receiving regular hemodialysis. After an initial 12-week period without study-protocolized inspiratory muscle training, participants will be randomly assigned to inspiratory muscle training plus usual care or usual care alone for 12 weeks. The primary outcome is the change in maximum inspiratory pressure from baseline to Week 12. The study will also assess lung function, walking capacity, handgrip strength, electrical activity of inspiratory muscles, dyspnea, body composition, health-related quality of life, and daily physical activity.

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.

Inclusion Criteria:

• Age 18 years or older
• Enrolled in a regular hemodialysis program for at least 3 months
• Receiving hemodialysis three times per week
• Able to understand study information
• Able to provide written informed consent

Exclusion Criteria:

• Recent history of clinically significant cardiac arrhythmia, acute myocardial infarction, unstable angina, severe valvular disease, or uncontrolled hypertension
• Medical condition that contraindicates an increase in intrathoracic negative pressure or performance of inspiratory muscle training
• Uncontrolled acute or decompensated medical condition that compromises participant safety or the validity of the assessments
• Severe cognitive impairment that prevents provision of informed consent or completion of study procedures