Respiratory Training in Hemodialysis Patients

NCT03153124 | Completed

• 1 other identifier: 64024117.4.0000.5479
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases

Keywords

Respiratory muscle strength; Renal insufficiency; Respiratory muscle training

Outcome Measures

Primary Outcomes (5)

• Manovacuometry

  RESPIRATORY MUSCLE FORCE

  Change from baseline in respiratory muscle force at 3 months

• Spirometry

  Pulmonary Function

  Change from baseline in Pulmonary Function at 3 months

• Distance in six-minute walk test

  analysis of distance

  change from baseline in distance at 3 months

• Quality of life questionnaire

  Analysis of the quality of life

  change from baseline in quality of life at 3 months

• HRR1

  heart rate recovery

  change from HR six minute walk test and seven minute

Study Arms (2)

Respiratory muscle training

EXPERIMENTAL

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

Other: Respiratory muscle training

Control

NO INTERVENTION

No intervention

Interventions

Respiratory muscle training OTHER

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

Respiratory muscle training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Faculdade de Ciências Médicas da Santa Casa de São Paulo: lead

Study Sites (1)

Santa Casa of Sao Paulo Medical School

São Paulo, São Paulo, 01221-020, Brazil

Location

Related Publications (3)

• 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.

  PMID: 23732715 BACKGROUND

• 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. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.

  PMID: 17568785 BACKGROUND

• 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.

  PMID: 25870564 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 15, 2017
• Study Start: April 12, 2017
• Primary Completion: September 30, 2017
• Study Completion: April 30, 2019
• Last Updated: July 29, 2022

Record last verified: 2019-11

Locations

BR (1)