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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01155128
• Other study ID #: EPI-0001-FB
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: June 30, 2010
• Last updated: March 1, 2012
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Federal University of Pelotas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Chronic Kidney Disease
• Chronic Renal Disease
• Hypertension
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• exercise aerobic
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

Locations

Country	Name	City	State
Brazil	University Federal of Pelotas	Pelotas	RS

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Pelotas	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of renal disease	randomized clinicals trials efficacy exercise in patients with chronic renal disease	30 th weeks	No
Secondary	quality of life	assessing quality of life in patients with chronic kidney disease receiving conservative treatment: a randomized clinical trial	30th weeks	No
Secondary	efficacy of physical exercise on blood pressure	same, patients pré-dialysis, randomized clinical trial	30 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	blood lipids	same, in patients pré-dialysis, randomized clinical tria	30 weeks	No

External Links

•   Center for Epidemiological Research