Respiratory Training in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Other: Respiratory muscle training

• Registration Number: NCT03153124
• Lead Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-12
• Study First Submitted: 2017-05-12
• Study First Submitted QC: 2017-05-12
• Study First Posted: 2017-05-15
• Primary Completion: 2017-09-30
• Study Completion: 2019-04-30
• Status Verified: 2019-11
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Respiratory muscle training	Respiratory muscle training	- three months of intradialytic training of a physical therapy protocol with PowerBreath.

Primary Outcome Measures

Name	Time	Method
Distance in six-minute walk test	change from baseline in distance at 3 months	analysis of distance
Spirometry	Change from baseline in Pulmonary Function at 3 months	Pulmonary Function
HRR1	change from HR six minute walk test and seven minute	heart rate recovery
Manovacuometry	Change from baseline in respiratory muscle force at 3 months	RESPIRATORY MUSCLE FORCE
Quality of life questionnaire	change from baseline in quality of life at 3 months	Analysis of the quality of life

Trial Locations

Locations (1)

Santa Casa of Sao Paulo Medical School; 🇧🇷 São Paulo, SP, Brazil