Skip to main content
OpenTrials
Completed

NCT Number: NCT03153124

Respiratory Training in Hemodialysis Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Santa Casa of Sao Paulo Medical School

São Paulo, 01221-020, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

respiratory muscle training

Other

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

Primary outcomes

  1. Manovacuometry

    Time frame: Change from baseline in respiratory muscle force at 3 months

    RESPIRATORY MUSCLE FORCE

  2. Spirometry

    Time frame: Change from baseline in Pulmonary Function at 3 months

    Pulmonary Function

  3. Distance in six-minute walk test

    Time frame: change from baseline in distance at 3 months

    analysis of distance

  4. Quality of life questionnaire

    Time frame: change from baseline in quality of life at 3 months

    Analysis of the quality of life

  5. HRR1

    Time frame: change from HR six minute walk test and seven minute

    heart rate recovery

Sponsors and collaborators

Lead sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Other

Registry information

Official study title

Effects of Respiratory Muscle Training in Muscle Force, Functional Capacity and Quality of Life in Hemodialysis Patients

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
May 15, 2017
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.