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Completed

NCT Number: NCT03041155

Respiratory Muscle Training in Hemodialysis Patients

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pronefron

Fortaleza, Ceará, 60165082, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle respiratory training

Behavioral

Muscle respiratory training during hemodialysis sessions

Primary outcomes

  1. endothelium glycocalyx biomarkers

    Time frame: 8 weeks

    plasma syndecan-1 (ng/mL)

Secondary outcomes

  1. Endothelium biomarker

    Time frame: 8 weeks

    ICAM (ng/mL)

  2. Endotehlium Biomarker

    Time frame: 8 weeks

    VCAM(ng/mL)

  3. Aberrant angiogenesis

    Time frame: 8 weeks

    Angiopoietin-2 (ng/mL)

  4. Oxidative stress

    Time frame: 8 weeks

    Plasma Malondialdehyde (mmol/L)

  5. Mean blood pressure

    Time frame: 8 weeks

    Blood pressure (mmHg)

Sponsors and collaborators

Lead sponsor

Universidade Federal do Ceara

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2017
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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