Exercise and Systemic Lupus Erythematosus

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01515163
First received: January 12, 2012
Last updated: January 12, 2016
Last verified: January 2016

January 12, 2012
January 12, 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 ] [ 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
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
Female
7 Years to 40 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01515163
Lupus and exercise
No
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