Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease

Study Overview
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Brief Summary
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Introduction: Chronic kidney disease (CKD) is now an important public health issue. While 0.1% of the population is on dialysis, approximately 4.5% of subjects have renal dysfunction (glomerular filtration rate <60 ml/min/1.73 m2). These patients have a high mortality of cardiovascular disease (CVD) with low quality of life and survival, despite high expenditure on their treatment. Hypertension (SAH) is both a cause and a complication of CKD. In addition, CKD and hypertension are risk factors for CVD. The nephropathy that are not on dialysis are less studied than those on dialysis. Strategies are needed to maintain renal function in these patients and mitigate the risk factors for CVD. A sedentary lifestyle can be an important determinant of morbidity of mortality. This study aims to determine the effect of exercise in patients with CKD not yet on dialysis. Methodology: A randomized clinical trial in hypertensive patients with CRF. After recruitment of participants and completed baseline surveys, those eligible for inclusion and consented to participate in the study will be randomly assigned. We use the technique of randomization in blocks of fixed size of six persons. Variables to be collected: demographic, socioeconomic, behavioral, anthropometric, blood pressure, laboratory tests (anemia, the lipid profile, blood glucose, inflammatory markers and number of peripheral endothelial progenitor cells) and quality of life. These patients will be re-interviewed in the middle period of the study (10 weeks) at the end of the intervention (20 weeks) and 10 weeks after the end of the intervention. The intervention group will participate in two weekly sessions of exercise. Therefore, facing the epidemic of CKD, this study intends to fill the data gaps about the impact of physical activity in patients with CKD on dialysis.

Detailed Description
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Eligibility: Individuals hypertensives diagnosed with GFR between 15 and 59 ml/min./1.73m2 Will be excluded from the study following patients: Diabetes mellitus; Severe physical disability Acute myocardial infarction in the last six months; Uncontrolled hypertension (systolic pressure> 180 mmHg and / or diastolic pressure> 110 mmHg); Angina at rest (unstable) or triggered by exercise; Congestive heart failure (> class II New York Heart Association; table X); Cardiac arrhythmias (> Lown class II,> 30 premature beats per minute); Subjects with prior renal transplant or dialysis.

Official Title
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Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease: a Randomized Clinical Trial

Conditions
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Cardiovascular Disease, Chronic Kidney Disease, Chronic Renal Disease, Hypertension

Intervention / Treatment
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* Behavioral: exercise aerobic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who have hypertension diagnosed with Glomerular Filtration Rate from 15 to 59 ml/min./1.73m2 characterized, therefore, in stages 3 or 4 chronic kidney disease enrolled in Basic Health Units (BHU) in the urban area of Pelotas , RS. Exclusion Criteria: Ia) Subjects diagnosed with diabetes mellitus; b) Patients with severe physical disability (lower limb amputation without prosthesis, orthopedic diseases that worsen with exercise); c) Individuals who have had acute myocardial infarction in the last six months; d) Subjects with hypertension at rest uncontrolled (systolic> 180 mmHg and / or diastolic pressure> 110 mmHg); e) Patients with angina at rest (unstable) or triggered by exercise; f) Individuals with congestive heart failure (> class II New York Heart Association; Table X); g) Patients with cardiac arrhythmias (> Lown class II,> 30 premature beats per minute); h) Individuals with peripheral vascular disease or moderate to severe; i) Subjects with prior renal transplant or dialysis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle interventions<br>After recruitment of the participants and consented to participate those deemed eligible for inclusion completed baseline surveys will be randomly assigned to an intervention group and another control group that will receive the usual care | Behavioral: exercise aerobic<br>* The intervention will consist of physical exercise sessions for approximately 60 minutes and two weekly sessions. The classes will consist of an initial part to exercises heating joint flexibility and lasting 10 minutes, a major part consists of aerobic exercise, lasting 20-30 minutes, and a piece of muscular endurance with exercises upper and lower limbs and abdomen, lasting 10-20 minutes. The intensity will be controlled through the Subjective Perception Scale Borg<br>* Other names: exercício físico;|
| Placebo Comparator: lifestyle interventions<br>After recruitment of the participants and consented to participate those deemed eligible for inclusion completed baseline surveys will be randomly assigned to an intervention group and another control group that will receive the usual care | Behavioral: exercise aerobic<br>* The intervention will consist of physical exercise sessions for approximately 60 minutes and two weekly sessions. The classes will consist of an initial part to exercises heating joint flexibility and lasting 10 minutes, a major part consists of aerobic exercise, lasting 20-30 minutes, and a piece of muscular endurance with exercises upper and lower limbs and abdomen, lasting 10-20 minutes. The intensity will be controlled through the Subjective Perception Scale Borg<br>* Other names: exercício físico;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression of renal disease | randomized clinicals trials efficacy exercise in patients with chronic renal disease | 30 th weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | assessing quality of life in patients with chronic kidney disease receiving conservative treatment: a randomized clinical trial | 30th weeks | 
| efficacy of physical exercise on blood pressure | same, patients pré-dialysis, randomized clinical trial | 30 weeks | 
| Effects of exercise on endothelial progenitor cells in pre-dialysis patients | same, endothelial progenitor cells in whole blood using flow cytometry (number)in pre-dialysis patients: randomized clinical trial | 30 weeks | 
| Ankle Brachial Pressure Index | same, association of Chronic Kidney Disease With the Spectrum of Ankle Brachial Index in patients pré-dialysis, randomized clinical trial | 30 weeks | 
| blood lipids | same, in patients pré-dialysis, randomized clinical tria | 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, exercise, sedentarism, chronic renal disease, failure renal chronic, proteinuria, progression, Renal Protective Effects of Exercise, quality of life changes with exercise in CKD, Endothelial progenitor cells in CKD, Chronic Kidney Disease and Ankle Brachial Index