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Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients

Primary Purpose

Systemic Lupus Erythematosus

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Supervised physical exercise
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus, endothelium, exercise

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • female systemic lupus erythematosus patients
  • 18 to 45 years of age
  • Fulfilled at least four criteria classification for lupus (ACR criteria, 1997) - Signed the consent form approved by the ethics committee of the institution

Exclusion Criteria:

  • Hemoglobin < 10 mg/dL
  • Neuropsychiatric, pulmonary, articular or vascular damage that would prevent the practice of exercise
  • Coronary disease or heart failure, functional class ≥ II
  • Pulmonary hypertension
  • Uncontrolled hypertension
  • Creatinine ≥ 1.4 mg/dL
  • Body mass index (BMI) ≥ 35 kg/m2
  • Diabetes mellitus
  • Uncontrolled hypothyroidism
  • Smoking in the last 12 months
  • Pregnancy
  • Menopause
  • Use of statins in the last three months
  • Practice of physical exercise in past three months
  • Overlap with other autoimmune rheumatic diseases, except antiphospholipid syndrome.

Sites / Locations

  • Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supervised physical exercise

No supervised physical exercise

Arm Description

Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.

No intervention for 16 weeks

Outcomes

Primary Outcome Measures

Endothelial function and endothelial progenitor cells (EPCs) number
Patients were evaluated at baseline and after 16 weeks by high-resolution ultrasound of brachial artery in resting conditions, after reactive hyperaemia (flow-mediated dilation-FMD) and after oral glyceryl trinitrate to assess endothelial function; EPCs were evaluated by flow cytometry using anti-CD34 (cluster of differentiation 34) (FITC), anti-CD133 (PE) and anti-kinase domain receptor (KDR) (APC)

Secondary Outcome Measures

Quality of life
Short Form-36
Vascular endothelial growth factor (VEGF)
ELISA
Disease activity
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
perceived exertion
Borg scale
Fatigue
Severity fatigue scale
Ergospirometric variables
Cardiopulmonary exercise test

Full Information

First Posted
October 20, 2012
Last Updated
October 22, 2012
Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01712529
Brief Title
Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
Official Title
Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the effect of supervised physical exercise on endothelial function and number of endothelial progenitor cells (EPCs) in patients with systemic lupus erythematosus, as well as evaluate the effect of supervised physical exercise on endothelium derived growth factor (VEGF) levels, disease activity, quality of life, fatigue, perceived exertion and cardiopulmonary exercise test variables.
Detailed Description
Several studies have shown that cardiovascular morbimortality is more frequent and early in SLE patients than in the general population and cardiovascular disease is an important cause of morbidity and mortality in systemic lupus erythematosus patients. Disturbances in endothelial function are implicated in its pathogenesis. Endothelial function also depends on endothelial progenitor cells (EPCs) that enhance angiogenesis, promote vascular repair and have potential as a marker of cardiovascular disease. Systemic lupus erythematosus patients have endothelial dysfunction and fewer EPCs. There are studies showing improvement of endothelial function and EPCs after physical exercise program in individuals with heart failure, diabetes and coronary arterial disease, but there isn't studies evaluating endothelial function and EPCs after.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic lupus erythematosus, endothelium, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised physical exercise
Arm Type
Experimental
Arm Description
Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
Arm Title
No supervised physical exercise
Arm Type
No Intervention
Arm Description
No intervention for 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Supervised physical exercise
Intervention Description
Women with systemic lupus erythematosus with availability to perform physical exercise were allocated in exercise group (EG) to practice supervised physical exercise for one hour, three times a week for 16 weeks. Those who were not available for this activity were allocated in the control group (CG). Intervention consisted of walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
Primary Outcome Measure Information:
Title
Endothelial function and endothelial progenitor cells (EPCs) number
Description
Patients were evaluated at baseline and after 16 weeks by high-resolution ultrasound of brachial artery in resting conditions, after reactive hyperaemia (flow-mediated dilation-FMD) and after oral glyceryl trinitrate to assess endothelial function; EPCs were evaluated by flow cytometry using anti-CD34 (cluster of differentiation 34) (FITC), anti-CD133 (PE) and anti-kinase domain receptor (KDR) (APC)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
Short Form-36
Time Frame
16 weeks
Title
Vascular endothelial growth factor (VEGF)
Description
ELISA
Time Frame
16 weeks
Title
Disease activity
Description
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time Frame
16 weeks
Title
perceived exertion
Description
Borg scale
Time Frame
16 weeks
Title
Fatigue
Description
Severity fatigue scale
Time Frame
16 weeks
Title
Ergospirometric variables
Description
Cardiopulmonary exercise test
Time Frame
16 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female systemic lupus erythematosus patients 18 to 45 years of age Fulfilled at least four criteria classification for lupus (ACR criteria, 1997) - Signed the consent form approved by the ethics committee of the institution Exclusion Criteria: Hemoglobin < 10 mg/dL Neuropsychiatric, pulmonary, articular or vascular damage that would prevent the practice of exercise Coronary disease or heart failure, functional class ≥ II Pulmonary hypertension Uncontrolled hypertension Creatinine ≥ 1.4 mg/dL Body mass index (BMI) ≥ 35 kg/m2 Diabetes mellitus Uncontrolled hypothyroidism Smoking in the last 12 months Pregnancy Menopause Use of statins in the last three months Practice of physical exercise in past three months Overlap with other autoimmune rheumatic diseases, except antiphospholipid syndrome.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilia I Sato, MD, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Sao Paulo
City
Sao Paulo
ZIP/Postal Code
04021051
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23970541
Citation
dos Reis-Neto ET, da Silva AE, Monteiro CM, de Camargo LM, Sato EI. Supervised physical exercise improves endothelial function in patients with systemic lupus erythematosus. Rheumatology (Oxford). 2013 Dec;52(12):2187-95. doi: 10.1093/rheumatology/ket283. Epub 2013 Aug 22.
Results Reference
derived

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Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients

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