Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

NCT ID: NCT04660383

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2024-03-31

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.

Conditions

Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

IMT 50

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.

Group Type: EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type: DEVICE

Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.

IMT 30

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.

Group Type: EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type: DEVICE

Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.

IMT 10

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.

Group Type: SHAM_COMPARATOR

Inspiratory Muscle Training

Intervention Type: DEVICE

Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ricardo Stein, PhD

Role: STUDY_DIRECTOR

Hospital de Clínicas de Porto Alegre

Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Central Contacts

Marcelo Teixeira, Master

Role: CONTACT

msteix@gmail.com

+55 51 992665901

Facility Contacts

Marcelo Teixeira, Master

Role: primary

msteix@gmail.com

51992665901

References

Teixeira MS, Ferrari F, Dipp T, Carvalho G, Bitencourt EDS, Saffi M, Stein R. Effects of intradialytic inspiratory muscle training at different intensities on diaphragm thickness and functional capacity: clinical trial protocol in patients undergoing haemodialysis. BMJ Open. 2023 Jan 27;13(1):e066778. doi: 10.1136/bmjopen-2022-066778.

Reference Type: DERIVED

PMID: 36707111 (View on PubMed)

Other Identifiers

2020-0458

Identifier Type: -

Identifier Source: org_study_id