Respiratory Training in Hemodialysis Patients

NCT ID: NCT03153124

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-12

Study Completion Date

2019-04-30

Brief Summary

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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

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Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Respiratory muscle training

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

Group Type EXPERIMENTAL

Respiratory muscle training

Intervention Type OTHER

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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Respiratory muscle training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Profa. Dra. Vera Lúcia dos Santos Alves

PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Santa Casa of Sao Paulo Medical School

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 23732715 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17568785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25870564 (View on PubMed)

Other Identifiers

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64024117.4.0000.5479

Identifier Type: -

Identifier Source: org_study_id

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