Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Device: Inspiratory Muscle Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT 50<br>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. | Device: Inspiratory Muscle Training<br>* Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.<br>|
| Experimental: IMT 30<br>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. | Device: Inspiratory Muscle Training<br>* Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.<br>|
| Sham Comparator: IMT 10<br>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. | Device: Inspiratory Muscle Training<br>* Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Capacity (6MWT) | 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. | Baseline, 3 months | 
| Change in Functional Capacity (CPET) | 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. | Baseline, 3 months | 
| Change in diaphragm hypertrophy | 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. | Baseline, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ambulatory blood pressure measurement (ABPM) | 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. | Baseline, 3 months | 
| Change in respiratory muscle strength | Maximal Inspiratory Measure and Maximal Expiratory Measure: will be carried out by GlobalMed® MVD300 manovacuometry equipment. | Baseline, 3 months | 
| Quality of Life assessed by KDQoL Short-Form | Assessed by Kidney Disease Quality of Life Short-Form | Baseline, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intradialytic training, Inspiratory Muscle Training, Diaphragm Hypertrophy, Functional capacity, End Stage Kidney Disease