Exercise and Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01515163
• Other study ID #: Lupus and exercise
• Status: Active, not recruiting
• Phase: N/A
• First received: January 12, 2012
• Last updated: January 12, 2016
• Start date: May 2010
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: July 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 7 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Behavioral:
• Exercise training
Aerobic exercise training, two times a week

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		3 months	No
Primary	Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp		3 months	No
Primary	Cytokine response - Plasma levels of TNF-a (pg/ml), IL-6 (pg/ml), IFN-type I (pg/ml), IL-10 (pg/ml)and IL-1ra (pg/ml)		3 months	No
Secondary	Cardiovascular parameters	Aerobic capacity, chronotropic function	3 months	No
Secondary	Muscle Strength	Upper and Lower-body muscle strength will be assessed by a 1-RM (repetition maximum) protocol	3 months	No