Effects of an Exercise Program in Patients With Hypertensive: a Randomized Clinical Trial Chronic Kidney Disease
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.
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Conditions
Cardiovascular Disease
Intervention
exercise aerobic
Location
Programa de Pós-graduação em Epidemiologia
Pelotas
/RS
Brazil
96020220
Status
Not yet recruiting
Source
Federal University of Pelotas
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01155128
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Exercise Test
Controlled physical activity, more strenuous than at rest, which is performed in order to allow assessment of physiological functions, particularly cardiovascular and pulmonary, but also aerobic capacity. Maximal (most intense) exercise is usually required but submaximal exercise is also used. The intensity of exercise is often graded, using criteria such as rate of work done, oxygen consumption, and heart rate.
Exercise Tolerance
The exercise capacity of an individual as measured by endurance (maximal exercise duration and/or maximal attained work load) during an EXERCISE TEST.
Microvascular Angina
ANGINA PECTORIS or angina-like chest pain with a normal coronary arteriogram and positive EXERCISE TEST. The cause of the syndrome is unknown. While its recognition is of clinical importance, its prognosis is excellent. (Braunwald, Heart Disease, 4th ed, p1346; Jablonski Dictionary of Syndromes & Eponymic Diseases, 2d ed). It is different from METABOLIC SYNDROME X, a syndrome characterized by INSULIN RESISTANCE and HYPERINSULINEMIA, that has increased risk for cardiovascular disease.
Pregnancy Complications, Cardiovascular
The co-occurrence of pregnancy and a cardiovascular disease. The disease may precede or follow FERTILIZATION and it may or may not have a deleterious effect on the pregnant woman or FETUS.
Anaerobic Threshold
The oxygen consumption level above which aerobic energy production is supplemented by anaerobic mechanisms during exercise, resulting in a sustained increase in lactate concentration and metabolic acidosis. The anaerobic threshold is affected by factors that modify oxygen delivery to the tissues; it is low in patients with heart disease. Methods of measurement include direct measure of lactate concentration, direct measurement of bicarbonate concentration, and gas exchange measurements.
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