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Respiratory Muscle Training in Hemodialysis Patients

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ClinicalTrials.gov Identifier: NCT03041155
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Alexandre Braga Liborio, 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.

Condition or disease Intervention/treatment Phase
Renal Failure Behavioral: Muscle respiratory training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Respiratory Muscle Training in Hemodialysis Patients: Effects on Physiologic Parameters and Endothelium-related Biomarkers
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : April 20, 2017
Actual Study Completion Date : April 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: treatment
Muscle respiratory training
Behavioral: Muscle respiratory training
Muscle respiratory training during hemodialysis sessions

No Intervention: control
No intervention



Primary Outcome Measures :
  1. endothelium glycocalyx biomarkers [ Time Frame: 8 weeks ]
    plasma syndecan-1 (ng/mL)


Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041155


Locations
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Brazil
Pronefron
Fortaleza, Ceara, Brazil, 60165082
Sponsors and Collaborators
Universidade Federal do Ceara
Investigators
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Principal Investigator: Alexandre Liborio, PHD Universidade Federal do Ceara
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Responsible Party: Alexandre Braga Liborio, Visitant Professor, Universidade Federal do Ceara
ClinicalTrials.gov Identifier: NCT03041155    
Obsolete Identifiers: NCT03075982
Other Study ID Numbers: 43697715.0.0000.5054
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases