Respiratory Training in Hemodialysis Patients
Primary Purpose
Chronic Kidney Diseases
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Respiratory muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases focused on measuring Respiratory muscle strength, Renal insufficiency, Respiratory muscle training
Eligibility Criteria
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
Sites / Locations
- Santa Casa of Sao Paulo Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Respiratory muscle training
Control
Arm Description
- three months of intradialytic training of a physical therapy protocol with PowerBreath.
No intervention
Outcomes
Primary Outcome Measures
Manovacuometry
RESPIRATORY MUSCLE FORCE
Spirometry
Pulmonary Function
Distance in six-minute walk test
analysis of distance
Quality of life questionnaire
Analysis of the quality of life
HRR1
heart rate recovery
Secondary Outcome Measures
Full Information
NCT ID
NCT03153124
First Posted
May 12, 2017
Last Updated
July 27, 2022
Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03153124
Brief Title
Respiratory Training in Hemodialysis Patients
Official Title
Effects of Respiratory Muscle Training in Muscle Force, Functional Capacity and Quality of Life in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 12, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Faculdade de Ciências Médicas da Santa Casa de São Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Respiratory muscle strength, Renal insufficiency, Respiratory muscle training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Respiratory muscle training
Arm Type
Experimental
Arm Description
- three months of intradialytic training of a physical therapy protocol with PowerBreath.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Respiratory muscle training
Intervention Description
The intervention group will perform three months of intradialytic training of a physical therapy protocol with PowerBreath
Primary Outcome Measure Information:
Title
Manovacuometry
Description
RESPIRATORY MUSCLE FORCE
Time Frame
Change from baseline in respiratory muscle force at 3 months
Title
Spirometry
Description
Pulmonary Function
Time Frame
Change from baseline in Pulmonary Function at 3 months
Title
Distance in six-minute walk test
Description
analysis of distance
Time Frame
change from baseline in distance at 3 months
Title
Quality of life questionnaire
Description
Analysis of the quality of life
Time Frame
change from baseline in quality of life at 3 months
Title
HRR1
Description
heart rate recovery
Time Frame
change from HR six minute walk test and seven minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Santa Casa of Sao Paulo Medical School
City
São Paulo
State/Province
SP
ZIP/Postal Code
01221-020
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23732715
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.
Results Reference
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PubMed Identifier
17568785
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. doi: 10.1038/sj.ki.5002343. Epub 2007 Jun 13.
Results Reference
background
PubMed Identifier
25870564
Citation
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.
Results Reference
background
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Respiratory Training in Hemodialysis Patients
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