NCT01712529

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

2.2 years

First QC Date

October 20, 2012

Last Update Submit

October 22, 2012

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosusendotheliumexercise

Outcome Measures

Primary Outcomes (1)

  • 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)

    16 weeks

Secondary Outcomes (6)

  • Quality of life

    16 weeks

  • Vascular endothelial growth factor (VEGF)

    16 weeks

  • Disease activity

    16 weeks

  • perceived exertion

    16 weeks

  • Fatigue

    16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Supervised physical exercise

EXPERIMENTAL

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

Behavioral: Supervised physical exercise

No supervised physical exercise

NO INTERVENTION

No intervention for 16 weeks

Interventions

Supervised physical exerciseBEHAVIORAL

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.

Supervised physical exercise

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • female systemic lupus erythematosus patients
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04021051, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 23970541DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, SystemicMotor Activity

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Emilia I Sato, MD, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PHD

Study Record Dates

First Submitted

October 20, 2012

First Posted

October 23, 2012

Study Start

September 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations

BR(1)