Kidney Failure, Chronic
Conditions
Keywords
intradialytic training, Inspiratory Muscle Training, Diaphragm Hypertrophy, Functional capacity, End Stage Kidney Disease
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.
Interventions
DEVICEInspiratory Muscle Training
Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in respiratory muscle strength | Baseline, 3 months | Maximal Inspiratory Measure and Maximal Expiratory Measure: will be carried out by GlobalMed® MVD300 manovacuometry equipment. |
| Quality of Life assessed by KDQoL Short-Form | Baseline, 3 months | Assessed by Kidney Disease Quality of Life Short-Form |
Countries
Brazil
Contacts
Primary ContactMarcelo Teixeira, Master
Outcome results
None listed