Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

NCT04660383 | Unknown

• 1 other identifier: 2020-0458
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Failure, Chronic

Keywords

intradialytic training; Inspiratory Muscle Training; Diaphragm Hypertrophy; Functional capacity; End Stage Kidney Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in ambulatory blood pressure measurement (ABPM)

  Baseline, 3 months

• Change in respiratory muscle strength

  Baseline, 3 months

• Quality of Life assessed by KDQoL Short-Form

  Baseline, 3 months

Study Arms (3)

IMT 50

EXPERIMENTAL

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

IMT 30

EXPERIMENTAL

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

IMT 10

SHAM COMPARATOR

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

Interventions

Inspiratory Muscle Training 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 30; IMT 50

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 91350-170, Brazil

Location

Related Publications (1)

• 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.

  PMID: 36707111 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo Stein, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Central Study Contacts

Marcelo Teixeira, Master

CONTACT

+55 51 992665901; msteix@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 9, 2020
• Study Start: December 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2024
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)