Exercise and Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01515163
Recruitment Status : Unknown
Verified January 2016 by Bruno Gualano, University of Sao Paulo.
Recruitment status was:  Active, not recruiting
First Posted : January 23, 2012
Last Update Posted : January 13, 2016
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

January 12, 2012
January 23, 2012
January 13, 2016
May 2010
July 2015   (Final data collection date for primary outcome measure)
  • 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 ]
  • Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp [ Time Frame: 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 ]
Same as current
Complete list of historical versions of study NCT01515163 on Archive Site
  • Cardiovascular parameters [ Time Frame: 3 months ]
    Aerobic capacity, chronotropic function
  • Muscle Strength [ Time Frame: 3 months ]
    Upper and Lower-body muscle strength will be assessed by a 1-RM (repetition maximum) protocol
Same as current
Not Provided
Not Provided
Exercise and Systemic Lupus Erythematosus
Not Provided
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Behavioral: Exercise training
Aerobic exercise training, two times a week
  • Experimental: Exercise
    3-month exercise training program
    Intervention: Behavioral: Exercise training
  • No Intervention: Control
    Control group
  • Experimental: Healthy control
    Intervention: Behavioral: Exercise training

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
July 2016
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
7 Years to 40 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
Lupus and exercise
Not Provided
Not Provided
Bruno Gualano, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP