Clinical trial NCT01155128: Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease
Official title: Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiovascular Disease
Chronic Kidney Disease
Chronic Renal Disease
Hypertension
Keywords: 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
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2010-07-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Progression of renal disease
timeFrame: 30 th weeks
Secondary outcomes:
measure: quality of life
timeFrame: 30th weeks
measure: efficacy of physical exercise on blood pressure
timeFrame: 30 weeks
measure: Effects of exercise on endothelial progenitor cells in pre-dialysis patients
timeFrame: 30 weeks
measure: Ankle Brachial Pressure Index
timeFrame: 30 weeks
measure: blood lipids
timeFrame: 30 weeks
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: University Federal of Pelotas
state: RS
Study officials:
affiliation: university federal de pelotas
name: Pedro Hallal, phd
role: STUDY_DIRECTOR
References:
citation: Barcellos FC, Del Vecchio FB, Reges A, Mielke G, Santos IS, Umpierre D, Bohlke M, Hallal PC. Exercise in patients with hypertension and chronic kidney disease: a randomized controlled trial. J Hum Hypertens. 2018 Jun;32(6):397-407. doi: 10.1038/s41371-018-0055-0. Epub 2018 Apr 4.