Systemic Lupus ErythematosusNCT01712529
Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
A study testing Supervised physical exercise in people with Systemic Lupus Erythematosus, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Supervised physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Supervised physical exercise
- Keywords
- Systemic lupus erythematosus, endothelium, exercise
- Medical subject headings
- Lupus Erythematosus, Systemic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised physical exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised physical exercise | Experimental | Walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter. Receives: Behavioral: Supervised physical exercise |
| No supervised physical exercise | No intervention | No intervention for 16 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 16 weeks
Secondary outcomes (6)
Quality of life
Short Form-36
Measured: 16 weeks
Vascular endothelial growth factor (VEGF)
ELISA
Measured: 16 weeks
Disease activity
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Measured: 16 weeks
perceived exertion
Borg scale
Measured: 16 weeks
Fatigue
Severity fatigue scale
Measured: 16 weeks
Ergospirometric variables
Cardiopulmonary exercise test
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startSep 2010
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Emilia Inoue Sato, Federal University of São Paulo
- Investigators
- Emilia I Sato, MD, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712529
- Sponsor's protocol ID
- 09295-5
- Status last verified
- Oct 2012
- First submitted
- 20 Oct 2012
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23970541
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supervised Physical Exercise on Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01712529
- Acronym / sponsor ID
- 09295-5
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, endothelium, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2010
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised physical exercise | Experimental | Behavioral: Supervised physical exerciseWalking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter. |
| No supervised physical exercise | No intervention | –No intervention for 16 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised physical exerciseWomen 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. | Behavioural | Supervised physical exercise |
Primary outcome
Endothelial function and endothelial progenitor cells (EPCs) number
Time frame: 16 weeks
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)
6 secondary outcomes
Quality of life
Time frame: 16 weeks
Vascular endothelial growth factor (VEGF)
Time frame: 16 weeks
Disease activity
Time frame: 16 weeks
perceived exertion
Time frame: 16 weeks
Fatigue
Time frame: 16 weeks
Ergospirometric variables
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2012.
- Derived from this study: PubMed 23970541dos 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia I Sato, MD, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised physical exercise in people with Systemic Lupus Erythematosus, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function and endothelial progenitor cells (EPCs) number (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01712529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2012.