Inspiratory Muscle Training in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Inspiratory muscle training
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic kidney disease on hemodialysis for more than 3 months;
- Clearance of urea during hemodialysis (Kt/V ≥ 1.2).
Exclusion Criteria:
- Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form;
- Patients with recent sequel of stroke;
- Disabling musculoskeletal disease;
- Uncontrolled hypertension (Systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg);
- Grade IV heart failure (NYHA) or decompensated;
- Uncontrolled diabetes (blood glucose > 300 mg/dL);
- Unstable angina;
- Fever and/or infectious disease;
- Recent acute myocardial infarction (two months);
- Active smokers.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Inspiratory muscle training group
Control group
Arm Description
Six times a week (three supervised at hemodialysis unit and other three times at home), 5 series, 10 repetitions, two-minutes interval or according to the patient tolerance.
The patients in this group will be evaluated at baseline and reassessed after five weeks of follow-up.
Outcomes
Primary Outcome Measures
Functional capacity
Functional capacity will be assessed by the distance walked in six-minute walk test (6MWT)
Secondary Outcome Measures
Muscle strength of inspiratory muscle
Muscle strength will be assessed by manovacuometry
Proximal strength of lower limbs
Proximal strength of lower limbs will be assessed by the number of repetitions performed in sit-and-stand test (SST).
Endothelial function
Endothelial function will be assessed by flow mediated dilation technique
Quality of Life
The quality of life will be assessed by questionnaire Kidney Disease and Quality-of-Life Short-Form (KDQOL-SFTM)
Full Information
NCT ID
NCT03082404
First Posted
March 12, 2017
Last Updated
March 12, 2017
Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT03082404
Brief Title
Inspiratory Muscle Training in Chronic Kidney Disease
Official Title
Effects of High-intensity Inspiratory Muscle Training in Chronic Kidney Disease: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 3, 2017 (Anticipated)
Primary Completion Date
May 2, 2017 (Anticipated)
Study Completion Date
June 2, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
Collaborators
Irmandade Santa Casa de Misericórdia de Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Chronic kidney disease is a renal injury and progressive and irreversible loss of kidney function and in its most advanced stage is called chronic renal failure. Although hemodialysis replace some kidney function, patients suffer some alterations characterized by "uremic syndrome" typically expressed by: motor neuropathy and/ or autonomic neuropathy, cardiac or musculoskeletal myopathies, peripheral vascular changes, among others. Thereby, the the adoption of physical exercise should be encouraged. However, it is known that the ability to exercise the subject in hemodialysis is low and they present weakness of the peripheral muscular system, including inspiratory muscles. The aim of this study is to assess the effects of inspiratory muscle training (IMT) on ventilatory muscle strength and functional capacity of patients with chronic kidney disease in hemodialysis. For this the following assessments will be performed before and after intervention: six-minute walk test to functional capacity; Kidney Disease and Quality of Life - Short Form questionnaire for quality of life; flow-mediated dilatation to endothelial function; sit-to-stand test for proximal strength of lower limbs. The subjects will be randomized into two groups, IMTG (inspiratory muscle training group) and CG (control group). The first will receive the IMT, for five weeks, three times a week, during hemodialysis session and the patients will be oriented to realize more three days at home. The control group only will be evaluated and re-evaluated. Expected results at the end of the protocol with IMT are: increased inspiratory muscle strength; longest distance covered on the six-minute walk test; improved quality of life; increased muscle strength of the lower limbs; improved endothelial function.
Detailed Description
The research will be developed in the hemodialysis unit of the Santa Clara hospital of Santa Casa de Misericórdia de Porto Alegre. After the selection of patients for eligibility criteria they will be randomized into IMTG or control group. First all patients will be evaluated, and subsequently the patients in the IMTG will be trained six times per week (three times at hemodialysis unit and three times at home) for five weeks using a linear pressure load device (POWERbreathe Plus Light Resistance@, England). The sessions will take place in the first hour of dialysis and the training protocol will consist of five series with 10 repetitions, each serie with a two-minute interval or according to the patient´s feedback, using the Borg modified scale. The overload will be adjusted weekly, beginning with 50% of maximum inspiratory pressure and increasing until 70% along the protocol period. At the end of follow-up, both groups will be evaluated in order to compare.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Chronic kidney disease, Inspiratory muscle training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Inspiratory muscle training group
Arm Type
Experimental
Arm Description
Six times a week (three supervised at hemodialysis unit and other three times at home), 5 series, 10 repetitions, two-minutes interval or according to the patient tolerance.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The patients in this group will be evaluated at baseline and reassessed after five weeks of follow-up.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Other Intervention Name(s)
High intensity inspiratory muscle training
Intervention Description
Inspiratory muscle training will be performed during the first hour of hemodialysis treatment and the protocol will consist of five series with 10 repetitions, each series with a two-minute interval of according to patient tolerance. The overload will be adjusted weekly, beginning with 50% of the maximum inspiratory pressure, during the first week, 60% of maximum inspiratory pressure in the second and third week and 70% of maximum inspiratory pressure in the fourth and fifth weeks. Maximum inspiratory pressure will be evaluated before the protocol period and adjusted weekly by manovacuometry.
Primary Outcome Measure Information:
Title
Functional capacity
Description
Functional capacity will be assessed by the distance walked in six-minute walk test (6MWT)
Time Frame
Five weeks
Secondary Outcome Measure Information:
Title
Muscle strength of inspiratory muscle
Description
Muscle strength will be assessed by manovacuometry
Time Frame
Five weeks
Title
Proximal strength of lower limbs
Description
Proximal strength of lower limbs will be assessed by the number of repetitions performed in sit-and-stand test (SST).
Time Frame
Five weeks
Title
Endothelial function
Description
Endothelial function will be assessed by flow mediated dilation technique
Time Frame
Five weeks
Title
Quality of Life
Description
The quality of life will be assessed by questionnaire Kidney Disease and Quality-of-Life Short-Form (KDQOL-SFTM)
Time Frame
Five weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with chronic kidney disease on hemodialysis for more than 3 months;
Clearance of urea during hemodialysis (Kt/V ≥ 1.2).
Exclusion Criteria:
Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form;
Patients with recent sequel of stroke;
Disabling musculoskeletal disease;
Uncontrolled hypertension (Systolic blood pressure > 230 mmHg and diastolic blood pressure > 120 mmHg);
Grade IV heart failure (NYHA) or decompensated;
Uncontrolled diabetes (blood glucose > 300 mg/dL);
Unstable angina;
Fever and/or infectious disease;
Recent acute myocardial infarction (two months);
Active smokers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo DM Plentz, PhD
Phone
(+55) 5185955153
Email
roplentz@yahoo.con.br
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo DM Plentz, PhD
Phone
(+55) 5185955153
Email
roplentz@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo DM Plentz, PhD
Organizational Affiliation
Federal University of Health Sciences of Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31122717
Citation
Dipp T, Macagnan FE, Schardong J, Fernandes RO, Lemos LC, Plentz RDM. Short period of high-intensity inspiratory muscle training improves inspiratory muscle strength in patients with chronic kidney disease on hemodialysis: a randomized controlled trial. Braz J Phys Ther. 2020 May-Jun;24(3):280-286. doi: 10.1016/j.bjpt.2019.04.003. Epub 2019 May 6.
Results Reference
derived
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Inspiratory Muscle Training in Chronic Kidney Disease
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