Respiratory Muscle Training in Hemodialysis Patients: Effects on Endothelium and Oxidative Stress Biomarkers

Respiratory Muscle Training Clinical Trial

Official title:

Respiratory Muscle Training in Hemodialysis Patients: Effects on Endothelium and Oxidative Stress Biomarkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03075982
• Other study ID #: 43697715.0.0000.5053
• Status: Completed
• Phase: N/A
• First received: March 6, 2017
• Last updated: March 24, 2017
• Start date: January 6, 2017
• Est. completion date: March 24, 2017

Study information

• Verified date: March 2017
• Source: Universidade Federal do Ceara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hemodialysis patients have altered pulmonary function and this is associated with impaired endothelial function and cardiovascular events. Respiratory muscle training (RMT) has the potential to improve cardiovascular outcomes in patients undergoing maintenance HD.This is a randomized controlled clinical trial including 41 patients undergoing thrice-weekly maintenance HD. Patients were randomly assigned in a 2:1 ratio to receive or not RMT during HD sessions for 8 weeks. Main outcomes were change in levels of the biomarkers related to endothelium activation (vascular cell adhesion molecule 1, VCAM-1, and intercellular adhesion molecule 1, ICAM-1), glycocalyx derangement (syndecan-1), aberrant angiogenesis (angiopoietin-2) and oxidative stress (malondialdehyde) from baseline. Other outcomes included changes in functional capacity and in pulmonary function test

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 24, 2017
• Est. primary completion date: March 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients receiving thrice-weekly maintenance HD for at least 3 months,

• cognitive and physical abilities to perform the study protocol procedures

Exclusion Criteria:

• chronic pulmonary disease

• patients with acute coronary syndrome, decompensated heart failure, major infectious process or hospitalization within the last 3 months.

Related Conditions & MeSH terms

• Respiratory Muscle Training

Intervention

Behavioral:
• Respiratory muscle training
Respiratory muscle training with threshold

Locations

Country	Name	City	State
Brazil	Pronefron	Fortaleza	Ceara

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Ceara

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycocalyx biomarker	Plasma syndecan (ng/ml)	8 weeks
Secondary	Endothelium biomarker	Plasma VCAM(ng/mL)	8 weeks
Secondary	endothelium biomarker 2	Plasma ICAM (ng/mL)	8 weeks
Secondary	aberrant angiogenesis	Angiopoietin-2 (pg/mL)	8 weeks
Secondary	Oxidative stress	Plasma Malondialdehyde (mmol/L)	8 weeks
Secondary	Mean Blood Pressure	Blood pressure (MMHG)	8 WEEKS