Chronic Kidney Disease Clinical Trial
Official title:
Effects of High-intensity Inspiratory Muscle Training in Chronic Kidney Disease: Randomized Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 25 |
Est. completion date | June 2, 2017 |
Est. primary completion date | May 2, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Federal University of Health Science of Porto Alegre | Irmandade Santa Casa de Misericórdia de Porto Alegre |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional capacity | Functional capacity will be assessed by the distance walked in six-minute walk test (6MWT) | Five weeks | |
Secondary | Muscle strength of inspiratory muscle | Muscle strength will be assessed by manovacuometry | Five weeks | |
Secondary | 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). | Five weeks | |
Secondary | Endothelial function | Endothelial function will be assessed by flow mediated dilation technique | Five weeks | |
Secondary | Quality of Life | The quality of life will be assessed by questionnaire Kidney Disease and Quality-of-Life Short-Form (KDQOL-SFTM) | Five weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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