Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

Kidney Failure, Chronic Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04660383
• Other study ID #: 2020-0458
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2022
• Est. completion date: March 2024

Study information

• Verified date: November 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Marcelo Teixeira, Master
• Phone: +55 51 992665901
• Email: msteix[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: March 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency
• Respiratory Aspiration

Intervention

Device:
• Inspiratory Muscle Training
Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Change in respiratory muscle strength	Maximal Inspiratory Measure and Maximal Expiratory Measure: will be carried out by GlobalMed® MVD300 manovacuometry equipment.	Baseline, 3 months
Secondary	Quality of Life assessed by KDQoL Short-Form	Assessed by Kidney Disease Quality of Life Short-Form	Baseline, 3 months