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

NCT01155128 | Unknown Phase 4

• 1 other identifier: EPI-0001-FB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Progression of renal disease

  randomized clinicals trials efficacy exercise in patients with chronic renal disease

  30 th weeks

Secondary Outcomes (5)

• quality of life

  30th weeks

• efficacy of physical exercise on blood pressure

  30 weeks

• Effects of exercise on endothelial progenitor cells in pre-dialysis patients

  30 weeks

• Ankle Brachial Pressure Index

  30 weeks

• blood lipids

  30 weeks

Study Arms (2)

Lifestyle interventions

EXPERIMENTAL

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

lifestyle interventions

PLACEBO COMPARATOR

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

Interventions

exercise aerobic BEHAVIORAL

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

Also known as: aerobic exercise, exercício físico

Lifestyle interventions; lifestyle interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Pelotas: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

University Federal of Pelotas

Pelotas, Rio Grande do Sul, 96020220, Brazil

Location

Related Publications (1)

• 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.

  PMID: 29615792 DERIVED

Related Links

• Center for Epidemiological Research

MeSH Terms

Conditions

Cardiovascular Diseases; Renal Insufficiency, Chronic; Hypertension; Motor Activity; Proteinuria; Disease Progression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Behavior; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pedro Hallal, phd

  university federal de pelotas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 1, 2010
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

BR (1)