NCT04660383

Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

Effects of Intradialytic Inspiratory Muscle Training at Different Intensities on Diaphragm Hypertrophy and Functional Capacity in Patients Undergoing Hemodialysis: a Randomized Clinical Trial.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with end stage kidney disease (ESKD). With intervention of thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (MIP).

Detailed description

Introduction: Chronic kidney disease (CKD), especially in its final stage (ESKD), is associated with an increased risk of cardiovascular complications and mortality. Part of this risk can be attributed to the fact that patients with ESKD adopt sedentary behavior. Objectives: To investigate the effects of Inspiratory Muscle Training (IMT) performed during hemodialysis (HD) procedures in patients with ESKD. Methodology: Randomized double-blind clinical trial, controlled by sham. Location: Nephrology Sector, Hospital de Clínicas de Porto Alegre (HCPA) Participants: three groups of 12 patients with ESKD on HD randomized to three IMT intensities. Intervention: Thirty-six IMT sessions, performed three times a week, at an intensity of 50%, 30% and 10% (sham) of the maximum inspiratory pressure (Pimax). Main outcomes: Functional capacity, diaphragm hypertrophy, respiratory muscle strength, lung volume, blood pressure and quality of life. Statistical Analysis: Presentation of data in absolute and relative numbers, and through means and standard deviations. To compare the groups, ANOVA will be used, with significance less than 0.05.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
DEVICE	Inspiratory Muscle Training	Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-09-01
• Completion: 2024-03-01
• First posted: 2020-12-09
• Last updated: 2022-11-22

Locations

1 site across 1 country: Brazil