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Inspiratory Muscle Training in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03082404
Recruitment Status : Not yet recruiting
First Posted : March 17, 2017
Last Update Posted : March 17, 2017
Sponsor:
Collaborator:
Irmandade Santa Casa de Misericórdia de Porto Alegre
Information provided by (Responsible Party):
Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: Inspiratory muscle training Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of High-intensity Inspiratory Muscle Training in Chronic Kidney Disease: Randomized Clinical Trial
Estimated Study Start Date : April 3, 2017
Estimated Primary Completion Date : May 2, 2017
Estimated Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Inspiratory muscle training group
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.
Other: Inspiratory muscle training
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.
Other Name: High intensity inspiratory muscle training

No Intervention: Control group
The patients in this group will be evaluated at baseline and reassessed after five weeks of follow-up.



Primary Outcome Measures :
  1. Functional capacity [ Time Frame: Five weeks ]
    Functional capacity will be assessed by the distance walked in six-minute walk test (6MWT)


Secondary Outcome Measures :
  1. Muscle strength of inspiratory muscle [ Time Frame: Five weeks ]
    Muscle strength will be assessed by manovacuometry

  2. Proximal strength of lower limbs [ Time Frame: Five weeks ]
    Proximal strength of lower limbs will be assessed by the number of repetitions performed in sit-and-stand test (SST).

  3. Endothelial function [ Time Frame: Five weeks ]
    Endothelial function will be assessed by flow mediated dilation technique

  4. Quality of Life [ Time Frame: Five weeks ]
    The quality of life will be assessed by questionnaire Kidney Disease and Quality-of-Life Short-Form (KDQOL-SFTM)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03082404


Contacts
Contact: Rodrigo DM Plentz, PhD (+55) 5185955153 roplentz@yahoo.con.br
Contact: Rodrigo DM Plentz, PhD (+55) 5185955153 roplentz@yahoo.com.br

Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Irmandade Santa Casa de Misericórdia de Porto Alegre
Investigators
Principal Investigator: Rodrigo DM Plentz, PhD Federal University of Health Sciences of Porto Alegre

Responsible Party: Rodrigo Della Méa Plentz, PhD, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT03082404     History of Changes
Other Study ID Numbers: HIIMT_CKD
First Posted: March 17, 2017    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre:
Chronic kidney disease
Inspiratory muscle training

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Respiratory Aspiration
Urologic Diseases
Renal Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes