Respiratory Muscle Training in Hemodialysis Patients
Primary Purpose
Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Muscle respiratory training
Sponsored by
About this trial
This is an interventional prevention trial for Renal Failure
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
Sites / Locations
- Pronefron
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
treatment
control
Arm Description
Muscle respiratory training
No intervention
Outcomes
Primary Outcome Measures
endothelium glycocalyx biomarkers
plasma syndecan-1 (ng/mL)
Secondary Outcome Measures
Endothelium biomarker
ICAM (ng/mL)
Endotehlium Biomarker
VCAM(ng/mL)
Aberrant angiogenesis
Angiopoietin-2 (ng/mL)
Oxidative stress
Plasma Malondialdehyde (mmol/L)
Mean blood pressure
Blood pressure (mmHg)
Full Information
NCT ID
NCT03041155
First Posted
January 30, 2017
Last Updated
July 15, 2017
Sponsor
Universidade Federal do Ceara
1. Study Identification
Unique Protocol Identification Number
NCT03041155
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
April 20, 2017 (Actual)
Study Completion Date
April 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Ceara
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
Muscle respiratory training
Arm Title
control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Muscle respiratory training
Intervention Description
Muscle respiratory training during hemodialysis sessions
Primary Outcome Measure Information:
Title
endothelium glycocalyx biomarkers
Description
plasma syndecan-1 (ng/mL)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Endothelium biomarker
Description
ICAM (ng/mL)
Time Frame
8 weeks
Title
Endotehlium Biomarker
Description
VCAM(ng/mL)
Time Frame
8 weeks
Title
Aberrant angiogenesis
Description
Angiopoietin-2 (ng/mL)
Time Frame
8 weeks
Title
Oxidative stress
Description
Plasma Malondialdehyde (mmol/L)
Time Frame
8 weeks
Title
Mean blood pressure
Description
Blood pressure (mmHg)
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Liborio, PHD
Organizational Affiliation
Universidade Federal do Ceara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pronefron
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60165082
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35018639
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.
Results Reference
derived
Learn more about this trial
Respiratory Muscle Training in Hemodialysis Patients
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