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

Primary Purpose

Cardiovascular Disease, Chronic Kidney Disease, Chronic Renal Disease

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
exercise aerobic
Sponsored by
Federal University of Pelotas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Federal of Pelotas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lifestyle interventions

lifestyle interventions

Arm Description

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

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

Outcomes

Primary Outcome Measures

Progression of renal disease
randomized clinicals trials efficacy exercise in patients with chronic renal disease

Secondary Outcome Measures

quality of life
assessing quality of life in patients with chronic kidney disease receiving conservative treatment: a randomized clinical trial
efficacy of physical exercise on blood pressure
same, patients pré-dialysis, randomized clinical trial
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
Ankle Brachial Pressure Index
same, association of Chronic Kidney Disease With the Spectrum of Ankle Brachial Index in patients pré-dialysis, randomized clinical trial
blood lipids
same, in patients pré-dialysis, randomized clinical tria

Full Information

First Posted
June 30, 2010
Last Updated
March 1, 2012
Sponsor
Federal University of Pelotas
Collaborators
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01155128
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
Collaborators
Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle interventions
Arm Type
Experimental
Arm Description
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
Arm Title
lifestyle interventions
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
exercise aerobic
Other Intervention Name(s)
aerobic exercise, exercício físico
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression of renal disease
Description
randomized clinicals trials efficacy exercise in patients with chronic renal disease
Time Frame
30 th weeks
Secondary Outcome Measure Information:
Title
quality of life
Description
assessing quality of life in patients with chronic kidney disease receiving conservative treatment: a randomized clinical trial
Time Frame
30th weeks
Title
efficacy of physical exercise on blood pressure
Description
same, patients pré-dialysis, randomized clinical trial
Time Frame
30 weeks
Title
Effects of exercise on endothelial progenitor cells in pre-dialysis patients
Description
same, endothelial progenitor cells in whole blood using flow cytometry (number)in pre-dialysis patients: randomized clinical trial
Time Frame
30 weeks
Title
Ankle Brachial Pressure Index
Description
same, association of Chronic Kidney Disease With the Spectrum of Ankle Brachial Index in patients pré-dialysis, randomized clinical trial
Time Frame
30 weeks
Title
blood lipids
Description
same, in patients pré-dialysis, randomized clinical tria
Time Frame
30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Hallal, phd
Organizational Affiliation
university federal de pelotas
Official's Role
Study Director
Facility Information:
Facility Name
University Federal of Pelotas
City
Pelotas
State/Province
RS
ZIP/Postal Code
96020220
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29615792
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.
Results Reference
derived
Links:
URL
http://www.epidemio-ufpel.org.br
Description
Center for Epidemiological Research

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

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