Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

Not Applicable

Not yet recruiting

• Conditions: Kidney Failure, Chronic

• Registration Number: NCT04660383
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22
• Study Start: 2022-12
• Primary Completion: 2023-09
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• CKD patients who have been on HD for at least three months;
• In physical conditions to perform the tests proposed by the study;
• With stable CKD for at least 30 days (with no hospitalization);

Exclusion Criteria

• Patients with a recent history of arrhythmias;
• Recent hospitalization (<3 months);
• Recent acute myocardial infarction (<6 weeks);
• HD routine less than 2X / week;
• Muscle or respiratory changes (eg, chronic obstructive pulmonary disease (COPD));
• Unstable angina;
• Severe valve disease;
• Uncontrolled hypertension;
• Hemoglobin concentration <10 g / dL;
• Participation in a study with intradialytic exercise in the six months preceding this study;
• Refusal to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Functional Capacity (6MWT)	Baseline, 3 months	The 6MWT is a useful, validated, and well-tolerated tool that requires no specialized equipment, used to determine the functional capacity of individuals with chronic kidney disease. 19 In addition, the 6MWT is able to represent the submaximal level of functional capacity (e.g., daily physical activity). The results will be defined as the difference in meters in distance covered at weeks 0 and 12. Participants will be instructed to walk on a flat, straight corridor, and will be told that the objective of the test is to walk as far as possible for six minutes at a self-selected speed.
Change in Functional Capacity (CPET)	Baseline, 3 months	Patients will be submitted to CPET on an exercise bike, using an incremental loading protocol according to the guidelines published by the American Thoracic Society / American College of Chest Physicians.
Change in diaphragm hypertrophy	Baseline, 3 months	Mode B ultrasound (EnVisor C, Philips, Bothell, Washington) with a 12.0 MHz ultrasound probe (L12-3, Philips) will be used for the image of the diaphragm in the apposition zone, the vertical section that rests against the lateral portion of the right rib cage, with the method described by Wait et al.

Secondary Outcome Measures

Name	Time	Method
Change in respiratory muscle strength	Baseline, 3 months	Maximal Inspiratory Measure and Maximal Expiratory Measure: will be carried out by GlobalMed® MVD300 manovacuometry equipment.
Change in ambulatory blood pressure measurement (ABPM)	Baseline, 3 months	ABPM is a method that allows indirect and intermittent blood pressure recordings for a period of 24 hours, while patients perform their daily life activities.
Quality of Life assessed by KDQoL Short-Form	Baseline, 3 months	Assessed by Kidney Disease Quality of Life Short-Form

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil