Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease: a Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cardiovascular Disease
- Sponsor
- Federal University of Pelotas
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Progression of renal disease
- Last Updated
- 14 years ago
Overview
Brief Summary
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
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.
Investigators
FRANKLIN CORREA BARCELLOS
Professor
Federal University of Pelotas
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Progression of renal disease
Time Frame: 30 th weeks
randomized clinicals trials efficacy exercise in patients with chronic renal disease
Secondary Outcomes
- blood lipids(30 weeks)
- efficacy of physical exercise on blood pressure(30 weeks)
- quality of life(30th weeks)
- Effects of exercise on endothelial progenitor cells in pre-dialysis patients(30 weeks)
- Ankle Brachial Pressure Index(30 weeks)