Respiratory Training in Hemodialysis Patients

Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT03153124
Collaborator
(none)
46
1
2
24.6
1.9

Study Details

Study Description

Brief Summary

Patients with chronic kidney disease in hemodialysis have complex syndrome with diverse effects on cardiovascular, nervous, respiratory, musculoskeletal, immune and endocrine-metabolic systems. With regard to the musculoskeletal structure, there is progressive muscular loss with consequent increase in muscle weakness, limited resistance, exercise intolerance and fatigue, as well as functional and morphological abnormalities characteristic of uremic myopathy. Respiratory muscles are also affected as a result of uremic myopathy, with decreased strength and resistance. Objective: to analyze the impact of respiratory muscle training on muscle strength, functional capacity and quality of life of patients with chronic kidney disease on hemodialysis. Method: This is a prospective, randomized study involving 46 patients followed by the dialysis unit of a university hospital, over 18 years old, of both genders who underwent hemodialysis for more than six months and who signed the informed consent form. Patients will be allocated into two groups: respiratory muscle training with PowerBreath and control. All will be evaluated for demographic data, respiratory muscle strength, lung function, functional capacity and quality of life. The intervention group will perform three months of intradialytic training of a physical therapy protocol with PowerBreath. Both groups will be reevaluated after three months.

Condition or Disease Intervention/Treatment Phase
  • Other: Respiratory muscle training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Respiratory Muscle Training in Muscle Force, Functional Capacity and Quality of Life in Hemodialysis Patients
Actual Study Start Date :
Apr 12, 2017
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Respiratory muscle training

- three months of intradialytic training of a physical therapy protocol with PowerBreath.

Other: Respiratory muscle training
The intervention group will perform three months of intradialytic training of a physical therapy protocol with PowerBreath

No Intervention: Control

No intervention

Outcome Measures

Primary Outcome Measures

  1. Manovacuometry [Change from baseline in respiratory muscle force at 3 months]

    RESPIRATORY MUSCLE FORCE

  2. Spirometry [Change from baseline in Pulmonary Function at 3 months]

    Pulmonary Function

  3. Distance in six-minute walk test [change from baseline in distance at 3 months]

    analysis of distance

  4. Quality of life questionnaire [change from baseline in quality of life at 3 months]

    Analysis of the quality of life

  5. HRR1 [change from HR six minute walk test and seven minute]

    heart rate recovery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients with chronic kidney disease undergoing hemodialysis for more than 6 months Both genders

  • ged 18 years or older

  • clinically stable

  • who agreed to participate in the study by signing a free informed consent form

Exclusion Criteria:
  • Patients with previous or current myoarticular or neurological disease;

  • That require some urgent or elective surgical intervention during the protocol;

  • Any cardiac decompensation such as arrhythmias, systolic blood pressure greater than 200mmHg or less than 60mmHg, diastolic blood pressure greater than 120mmHg or less than 40mmHg;

  • Decompensated diabetes mellitus and acute systemic infection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santa Casa of Sao Paulo Medical School São Paulo SP Brazil 01221-020

Sponsors and Collaborators

  • Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Profa. Dra. Vera Lúcia dos Santos Alves, PHD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:
NCT03153124
Other Study ID Numbers:
  • 64024117.4.0000.5479
First Posted:
May 15, 2017
Last Update Posted:
Jul 29, 2022
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Profa. Dra. Vera Lúcia dos Santos Alves, PHD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022