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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
FRANKLIN CORREA BARCELLOS, Federal University of Pelotas
ClinicalTrials.gov Identifier:
NCT01155128
First received: June 30, 2010
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Cardiovascular Disease
Chronic Kidney Disease
Chronic Renal Disease
Hypertension
Behavioral: exercise aerobic
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of an Exercise Program in Patients With Hypertensive Chronic Kidney Disease: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Federal University of Pelotas:

Primary Outcome Measures:
  • Progression of renal disease [ Time Frame: 30 th weeks ] [ Designated as safety issue: No ]
    randomized clinicals trials efficacy exercise in patients with chronic renal disease


Secondary Outcome Measures:
  • quality of life [ Time Frame: 30th weeks ] [ Designated as safety issue: No ]
    assessing quality of life in patients with chronic kidney disease receiving conservative treatment: a randomized clinical trial

  • efficacy of physical exercise on blood pressure [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    same, patients pré-dialysis, randomized clinical trial

  • Effects of exercise on endothelial progenitor cells in pre-dialysis patients [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    same, endothelial progenitor cells in whole blood using flow cytometry (number)in pre-dialysis patients: randomized clinical trial

  • Ankle Brachial Pressure Index [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    same, association of Chronic Kidney Disease With the Spectrum of Ankle Brachial Index in patients pré-dialysis, randomized clinical trial

  • blood lipids [ Time Frame: 30 weeks ] [ Designated as safety issue: No ]
    same, in patients pré-dialysis, randomized clinical tria


Estimated Enrollment: 200
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyle interventions
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
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
Other Names:
  • aerobic exercise
  • exercício físico
Placebo Comparator: lifestyle interventions
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
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
Other Names:
  • aerobic exercise
  • exercício físico

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155128

Locations
Brazil
University Federal of Pelotas
Pelotas, RS, Brazil, 96020220
Sponsors and Collaborators
Federal University of Pelotas
Ministry of Health, Brazil
Investigators
Study Director: Pedro Hallal, phd university federal de pelotas
  More Information

Additional Information:
No publications provided

Responsible Party: FRANKLIN CORREA BARCELLOS, Professor, Federal University of Pelotas
ClinicalTrials.gov Identifier: NCT01155128     History of Changes
Other Study ID Numbers: EPI-0001-FB
Study First Received: June 30, 2010
Last Updated: March 1, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Pelotas:
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

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Vascular Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 26, 2014