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
  Purpose

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 Intervention
Systemic Lupus Erythematosus
Behavioral: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 90
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   7 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515163

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 05403-000
Contact: Cleonice Santos    2661-8022    lacre@hcnet.usp.br   
Sub-Investigator: Bruno Gualano, PhD         
Sponsors and Collaborators
University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo

Additional 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
Study First Received: January 12, 2012
Last Updated: December 11, 2013
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on September 30, 2014