Inspiratory Muscle Training in Chronic Kidney Disease
Effects of High-intensity Inspiratory Muscle Training in Chronic Kidney Disease: Randomized Clinical Trial
1 other identifier
interventional
25
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2017
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2017
CompletedFirst Posted
Study publicly available on registry
March 17, 2017
CompletedStudy Start
First participant enrolled
April 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2017
CompletedMarch 17, 2017
March 1, 2017
29 days
March 12, 2017
March 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functional capacity
Functional capacity will be assessed by the distance walked in six-minute walk test (6MWT)
Five weeks
Secondary Outcomes (4)
Muscle strength of inspiratory muscle
Five weeks
Proximal strength of lower limbs
Five weeks
Endothelial function
Five weeks
Quality of Life
Five weeks
Study Arms (2)
Inspiratory muscle training group
EXPERIMENTALSix 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.
Control group
NO INTERVENTIONThe patients in this group will be evaluated at baseline and reassessed after five weeks of follow-up.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with chronic kidney disease on hemodialysis for more than 3 months;
- Clearance of urea during hemodialysis (Kt/V ≥ 1.2).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 31122717DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodrigo DM Plentz, PhD
Federal University of Health Sciences of Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 12, 2017
First Posted
March 17, 2017
Study Start
April 3, 2017
Primary Completion
May 2, 2017
Study Completion
June 2, 2017
Last Updated
March 17, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share