Inspiratory Muscle Training During Hemodialysis

Condition(s) studied

Investigational drug(s) / intervention(s)

Inspiratory Muscle Training: Intradialytic inspiratory muscle training will be performed using the POWERbreathe KH2 electronic device. Training will begin approximately 30 minutes after the start of the hemodialysis session after confirmation of clinical and hemodynamic stability. Participants will be seated in the hemodialysis chair with the backrest raised to at least 45 degrees. The initial program will be performed three times weekly for 12 weeks, for a total of 36 planned sessions. Each session will include three sets of 30 inhalations against a resistance corresponding to 50 percent of maximum inspiratory pressure, with a two-minute rest between sets. Maximum inspiratory pressure will be reassessed after every six completed sessions, and resistance will be adjusted to 50 percent of the newly measured value. Training will be interrupted for chest pain, intolerable dyspnea, desaturation, hypotension, arrhythmia, intolerable fatigue, participant request, or any sign or symptom raising clinical concern.

Usual Care: Usual care consists of the regular hemodialysis schedule and the clinical and nursing care routinely provided by the hemodialysis unit. No study-protocolized inspiratory muscle training will be administered.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Maximum Inspiratory Pressure From Baseline to Week 12 — Baseline at T0 and post-intervention at Week 12
  Maximum inspiratory pressure will be measured using the POWERbreathe KH2 device with the participant seated with back support before the second or third weekly hemodialysis session. The outcome is the change in maximum inspiratory pressure, expressed in cmH2O.

Trial sites (1)