Clinical trial NCT03041155: Respiratory Muscle Training in Hemodialysis Patients
Official title: Respiratory Muscle Training in Hemodialysis Patients: Effects on Physiologic Parameters and Endothelium-related Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
First posted: 2017-02-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: endothelium glycocalyx biomarkers
timeFrame: 8 weeks
Secondary outcomes:
measure: Endothelium biomarker
timeFrame: 8 weeks
measure: Endotehlium Biomarker
timeFrame: 8 weeks
measure: Aberrant angiogenesis
timeFrame: 8 weeks
measure: Oxidative stress
timeFrame: 8 weeks
measure: Mean blood pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Pronefron
state: Ceara
Study officials:
affiliation: Universidade Federal do Ceara
name: Alexandre Liborio, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.