Respiratory Training in Hemodialysis Patients

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153124
• Other study ID #: 64024117.4.0000.5479
• Status: Completed
• Phase: N/A
• Start date: April 12, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: November 2019
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 30, 2019
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Brazil	Santa Casa of Sao Paulo Medical School	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Kaltsatou A, Sakkas GK, Poulianiti KP, Koutedakis Y, Tepetes K, Christodoulidis G, Stefanidis I, Karatzaferi C. Uremic myopathy: is oxidative stress implicated in muscle dysfunction in uremia? Front Physiol. 2015 Mar 30;6:102. doi: 10.3389/fphys.2015.00102. eCollection 2015. Review. — View Citation

Levey AS, Atkins R, Coresh J, Cohen EP, Collins AJ, Eckardt KU, Nahas ME, Jaber BL, Jadoul M, Levin A, Powe NR, Rossert J, Wheeler DC, Lameire N, Eknoyan G. Chronic kidney disease as a global public health problem: approaches and initiatives - a position statement from Kidney Disease Improving Global Outcomes. Kidney Int. 2007 Aug;72(3):247-59. Epub 2007 Jun 13. — View Citation

Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007. — View Citation

Outcome

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