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NOT YET RECRUITING
NCT07811947
NA

Inspiratory Muscle Training During Hemodialysis

Sponsor: Tecsam - Tecnologia e Servicos Medicos

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2026-09-20

Completion Date

2027-09

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

BEHAVIORAL

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.

OTHER

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.

Locations (1)

Tecsam - Tecnologia e Serviços Médicos

Mirandela, Braganza District, Portugal