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Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

Primary Purpose

Kidney Failure, Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Failure, Chronic focused on measuring intradialytic training, Inspiratory Muscle Training, Diaphragm Hypertrophy, Functional capacity, End Stage Kidney Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;
  • Peripheral vascular disease;
  • Liver disease;
  • Hemoglobin concentration <10 g / dL;
  • Problem vascular access (fistula);
  • Participation in a study with intradialytic exercise in the six months preceding this study;
  • Refusal to participate in the study.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

IMT 50

IMT 30

IMT 10

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
Change in respiratory muscle strength
Maximal Inspiratory Measure and Maximal Expiratory Measure: will be carried out by GlobalMed® MVD300 manovacuometry equipment.
Quality of Life assessed by KDQoL Short-Form
Assessed by Kidney Disease Quality of Life Short-Form

Full Information

First Posted
December 1, 2020
Last Updated
November 17, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04660383
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
intradialytic training, Inspiratory Muscle Training, Diaphragm Hypertrophy, Functional capacity, End Stage Kidney Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMT 50
Arm Type
Experimental
Arm Description
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.
Arm Title
IMT 30
Arm Type
Experimental
Arm Description
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.
Arm Title
IMT 10
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.
Primary Outcome Measure Information:
Title
Change in Functional Capacity (6MWT)
Description
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.
Time Frame
Baseline, 3 months
Title
Change in Functional Capacity (CPET)
Description
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.
Time Frame
Baseline, 3 months
Title
Change in diaphragm hypertrophy
Description
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.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in ambulatory blood pressure measurement (ABPM)
Description
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.
Time Frame
Baseline, 3 months
Title
Change in respiratory muscle strength
Description
Maximal Inspiratory Measure and Maximal Expiratory Measure: will be carried out by GlobalMed® MVD300 manovacuometry equipment.
Time Frame
Baseline, 3 months
Title
Quality of Life assessed by KDQoL Short-Form
Description
Assessed by Kidney Disease Quality of Life Short-Form
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo Teixeira, Master
Phone
+55 51 992665901
Email
msteix@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Stein, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-170
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelo Teixeira, Master
Phone
51992665901
Email
msteix@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Intradialytic Inspiratory Muscle Training at Different Intensities and Functional Capacity

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