Respiratory Muscle Training in Hemodialysis Patients

Respiratory Muscle Training in Hemodialysis Patients: Effects on Physiologic Parameters and Endothelium-related Biomarkers

The research protocol is a Randomized Clinical Trial that has the effectiveness of a given respiratory muscle training protocol over the indicative variables: Pulmonary function; Markers of oxidative stress and inflammation, endothelial markers and Quality of life in patients with chronic kidney disease undergoing hemodialysis. According to the Investigators, this topic was proposed since it is known that several pulmonary complications occur as a consequence of chronic kidney disease due to uremic myopathy. Therefore, the hypothesis is that the application of a respiratory muscle training protocol will contribute positively pulmonary functionality and a decrease in oxidative stress and inflammation in chronic kidney patients, consequently, will bring improvement in the quality of life for these patients. The Patients will be divided into two groups: control group - No intervention of the Muscular Training (CG) And Intervention Group (GI). The intervention protocol will be composed of respiratory muscle training And lasts for two (2) months, with three (3) visits per week. It will be carried out through Threshold PeP appliance. The twelve (12) first training sessions will have a total duration of 30 minutes 15 minutes with inspiratory load of 20 cmH2O and 15 minutes with expiratory load of 20 CmH 2 O; and the others (12) twelve sessions will last 40 minutes each, with 20 minutes with an inspiratory load of 20 CmH2O and 20 minutes with expiratory load of 20 cmH2O. The variables evaluated will be: muscular strength Respiratory (maximum inspiratory pressure and maximum expiratory pressure - Pimáx and Pemáx); Lung function (Slow Vital Capacity - CVL, forced expiratory volume in the first minute - VEF1, Vital Capacity Forced - CVF and Maximum Voluntary Ventilation - VVM); Serum levels of oxidative stress markers, endothelial markers and endothelin.

Study Overview

• Status: Completed
• Conditions: Renal Failure
• Intervention / Treatment: Behavioral: Muscle respiratory training

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Ceara
    • Fortaleza, Ceara, Brazil, 60165082
      • Pronefron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Maintenance hemodialysis for more than 3 months
• No COPD diagnosis

Exclusion Criteria:

• Decompensated Heart failure
• Acute coronary disease in the last 3 months
• Active infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; No intervention
Experimental: treatment; Muscle respiratory training	Behavioral: Muscle respiratory training; Muscle respiratory training during hemodialysis sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endothelium glycocalyx biomarkers	plasma syndecan-1 (ng/mL)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelium biomarker	ICAM (ng/mL)	8 weeks
Endotehlium Biomarker	VCAM(ng/mL)	8 weeks
Aberrant angiogenesis	Angiopoietin-2 (ng/mL)	8 weeks
Oxidative stress	Plasma Malondialdehyde (mmol/L)	8 weeks
Mean blood pressure	Blood pressure (mmHg)	8 weeks

Collaborators and Investigators

• Sponsor: Universidade Federal do Ceara
• Investigators: Principal Investigator: Alexandre Liborio, PHD, Universidade Federal do Ceara

Publications and helpful links

General Publications

• Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): April 20, 2017
• Study Completion (Actual): April 20, 2017

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (Estimate): February 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 15, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: 43697715.0.0000.5054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No