Clinical trial NCT04660383: Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity
Official title: Effects of Intradialytic Inspiratory Muscle Training at Different Intensities on Diaphragm Hypertrophy and Functional Capacity in Patients Undergoing Hemodialysis: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Failure, Chronic
Keywords: intradialytic training
Inspiratory Muscle Training
Diaphragm Hypertrophy
Functional capacity
End Stage Kidney Disease
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Functional Capacity (6MWT)
timeFrame: Baseline, 3 months
measure: Change in Functional Capacity (CPET)
timeFrame: Baseline, 3 months
measure: Change in diaphragm hypertrophy
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in ambulatory blood pressure measurement (ABPM)
timeFrame: Baseline, 3 months
measure: Change in respiratory muscle strength
timeFrame: Baseline, 3 months
measure: Quality of Life assessed by KDQoL Short-Form
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Ricardo Stein, PhD
role: STUDY_DIRECTOR
References: