Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

Hospital de Clinicas de Porto Alegre

Status: Not yet enrolling

Conditions: Kidney Failure, Chronic

Treatments: Device: Inspiratory Muscle Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04660383

2020-0458

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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36 participants in 3 patient groups

IMT 50

Experimental group

Description:

IMT intervention: IMT50 - 50% of the maximum inspiratory pressure (MIP), using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs.

Treatment:

Device: Inspiratory Muscle Training

IMT 30

Experimental group

Description:

IMT intervention: IMT30 - 30% of the maximum inspiratory pressure, using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs.

Treatment:

Device: Inspiratory Muscle Training

IMT 10

Sham Comparator group

Description:

IMT intervention: IMT10 - 10% of the maximum inspiratory pressure, using equipment "Threshold IMT®" or "Power Breathe®", which are respiratory incentives of linear pressure load, where the patient uses a nose clip and breathes through a mouthpiece with a resistance in the inspiratory branch, using the respective MIPs.

Treatment:

Device: Inspiratory Muscle Training