Respiratory Muscle Training in Hemodialysis Patients

NCT ID: NCT03041155

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-04-20

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.

Conditions

Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

treatment

Muscle respiratory training

Group Type: EXPERIMENTAL

Muscle respiratory training

Intervention Type: BEHAVIORAL

Muscle respiratory training during hemodialysis sessions

control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Muscle respiratory training

Muscle respiratory training during hemodialysis sessions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Ceara

OTHER

Sponsor Role: lead

Responsible Party

Alexandre Braga Liborio

Visitant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandre Liborio, PHD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Ceara

Locations

Pronefron

Fortaleza, Ceará, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 35018639 (View on PubMed)

Other Identifiers

43697715.0.0000.5054

Identifier Type: -

Identifier Source: org_study_id

NCT03075982

Identifier Type: -

Identifier Source: nct_alias