NCT03041155

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

January 30, 2017

Last Update Submit

July 15, 2017

Conditions

Renal Failure

Outcome Measures

Primary Outcomes (1)

  • endothelium glycocalyx biomarkers

    plasma syndecan-1 (ng/mL)

    8 weeks

Secondary Outcomes (5)

  • Endothelium biomarker

    8 weeks

  • Endotehlium Biomarker

    8 weeks

  • Aberrant angiogenesis

    8 weeks

  • Oxidative stress

    8 weeks

  • Mean blood pressure

    8 weeks

Study Arms (2)

treatment

EXPERIMENTAL

Muscle respiratory training

Behavioral: Muscle respiratory training

control

NO INTERVENTION

No intervention

Interventions

Muscle respiratory trainingBEHAVIORAL

Muscle respiratory training during hemodialysis sessions

treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Maintenance hemodialysis for more than 3 months
  • No COPD diagnosis

You may not qualify if:

  • Decompensated Heart failure
  • Acute coronary disease in the last 3 months
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pronefron

Fortaleza, Ceará, 60165082, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 35018639DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Alexandre Liborio, PHD

    Universidade Federal do Ceara

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Visitant Professor

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 2, 2017

Study Start

February 1, 2017

Primary Completion

April 20, 2017

Study Completion

April 20, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)