Exercise and Systemic Lupus Erythematosus

January 12, 2016 updated by: Bruno Gualano, University of Sao Paulo
The investigators hypothesize that a three-month aerobic exercise training program will positively affect the lipid profile, insulin sensitivity , cytokine profile, the cardiovascular parameters and muscle strength in SLE patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-000
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 7 and 40 years
  • SLEDAI ≤ 4

Exclusion Criteria:

  • Cardiovascular dysfunction
  • Rhythm and conduction disorders
  • Musculoskeletal disturbances
  • Kidney and pulmonary involvements
  • Peripheral neuropathy
  • Use of tobacco
  • Treatment with lipid-lowering or hypoglycemic drugs
  • Fibromyalgia
  • Use of chronotropic or antihypertensive drugs
  • Physically active subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control group
Experimental: Exercise
3-month exercise training program
Behavioral: Exercise training
Aerobic exercise training, two times a week
Experimental: Healthy control
Behavioral: Exercise training
Aerobic exercise training, two times a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lipid profile - Plasma levels of total cholesterol (mg/dl), VLDL-chol (mg/dl) HDL-chol (mg/dl), LDL-chol (mg/dl), triglycerides (mg/dl), Apolipoprotein AI and AII (mg/dl) and Apolipoprotein B (mg/dl)
Time Frame: 3 months
3 months
Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp
Time Frame: 3 months
3 months
Cytokine response - Plasma levels of TNF-α (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular parameters
Time Frame: 3 months
Aerobic capacity, chronotropic function
3 months
Muscle Strength
Time Frame: 3 months
Upper and Lower-body muscle strength will be assessed by a 1-RM (repetition maximum) protocol
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

July 1, 2015

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2016

Last Update Submitted That Met QC Criteria

January 12, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lupus and exercise

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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