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Exercise and Systemic Lupus Erythematosus

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Behavioral: Exercise training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2010
Actual Primary Completion Date : July 2015
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 ]
  2. Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp [ Time Frame: 3 months ]
  3. 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 ]

Secondary Outcome Measures :
  1. Cardiovascular parameters [ Time Frame: 3 months ]
    Aerobic capacity, chronotropic function

  2. Muscle Strength [ Time Frame: 3 months ]
    Upper and Lower-body muscle strength will be assessed by a 1-RM (repetition maximum) protocol



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Ages Eligible for Study:   7 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515163


Locations
Brazil
University of Sao Paulo
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruno Gualano, PhD, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01515163     History of Changes
Other Study ID Numbers: Lupus and exercise
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases