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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
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Inspiratory muscle training

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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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