Respiratory Muscle Training in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Renal Failure
• Interventions: Behavioral: Muscle respiratory training

• Registration Number: NCT03041155
• Lead Sponsor: Universidade Federal do Ceara

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-01-31
• Study Start: 2017-02-01
• Study First Posted: 2017-02-02
• Primary Completion: 2017-04-20
• Study Completion: 2017-04-20
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-15
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment	Muscle respiratory training	Muscle respiratory training

Primary Outcome Measures

Name	Time	Method
endothelium glycocalyx biomarkers	8 weeks	plasma syndecan-1 (ng/mL)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pronefron; 🇧🇷 Fortaleza, Ceara, Brazil