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

Phase 4

• Conditions: Hypertension; Chronic Kidney Disease; Chronic Renal Disease; Cardiovascular Disease
• Interventions: Behavioral: exercise aerobic

• Registration Number: NCT01155128
• Lead Sponsor: Federal University of Pelotas

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.

Study Timeline

• Study First Submitted: 2010-06-30
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Study Start: 2011-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-05
• Primary Completion: 2012-11
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle interventions	exercise aerobic	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
lifestyle interventions	exercise aerobic	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

Primary Outcome Measures

Name	Time	Method
Progression of renal disease	30 th weeks	randomized clinicals trials efficacy exercise in patients with chronic renal disease

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Federal of Pelotas; 🇧🇷 Pelotas, RS, Brazil