Exercise and Systemic Lupus Erythematosus

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01515163
First received: January 12, 2012
Last updated: December 11, 2013
Last verified: December 2013

January 12, 2012
December 11, 2013
May 2010
July 2014   (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 ] [ Designated as safety issue: No ]
  • Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01515163 on ClinicalTrials.gov Archive Site
  • Cardiovascular parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Aerobic capacity, chronotropic function
  • Muscle Strength [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Prado DM, Benatti FB, de Sá-Pinto AL, Hayashi AP, Gualano B, Pereira RM, Sallum AM, Bonfá E, Silva CA, Roschel H. Exercise training in childhood-onset systemic lupus erythematosus: a controlled randomized trial. Arthritis Res Ther. 2013 Mar 26;15(2):R46. doi: 10.1186/ar4205.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
December 2015
July 2014   (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
Female
7 Years to 40 Years
No
Brazil
 
NCT01515163
Lupus and exercise
No
Bruno Gualano, University of Sao Paulo
University of Sao Paulo
Not Provided
Not Provided
University of Sao Paulo
December 2013

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