Exercise and Systemic Lupus Erythematosus

This study is currently recruiting participants.
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
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

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 April 17, 2014