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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01515163
Other study ID # Lupus and exercise
Secondary ID
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


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
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