Back to resultsExercise and Systemic Lupus Erythematosus
Primary Purpose
Systemic Lupus Erythematosus
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus
Eligibility 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
Sites / Locations
- University of Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
Exercise
Control
Healthy control
Arm Description
3-month exercise training program
Control group
Outcomes
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)
Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp
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)
Secondary Outcome Measures
Cardiovascular parameters
Aerobic capacity, chronotropic function
Muscle Strength
Upper and Lower-body muscle strength will be assessed by a 1-RM (repetition maximum) protocol
Full Information
NCT ID
NCT01515163
First Posted
January 12, 2012
Last Updated
January 12, 2016
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01515163
Brief Title
Exercise and Systemic Lupus Erythematosus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
3-month exercise training program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group
Arm Title
Healthy control
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Aerobic exercise training, two times a week
Primary Outcome Measure Information:
Title
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
Title
Insulin sensitivity as measured by the Hyperinsulinemic-Euglycemic Clamp
Time Frame
3 months
Title
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 Measure Information:
Title
Cardiovascular parameters
Description
Aerobic capacity, chronotropic function
Time Frame
3 months
Title
Muscle Strength
Description
Upper and Lower-body muscle strength will be assessed by a 1-RM (repetition maximum) protocol
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
29755474
Citation
Benatti FB, Miyake CNH, Dantas WS, Zambelli VO, Shinjo SK, Pereira RMR, Silva MER, Sa-Pinto AL, Borba E, Bonfa E, Gualano B. Exercise Increases Insulin Sensitivity and Skeletal Muscle AMPK Expression in Systemic Lupus Erythematosus: A Randomized Controlled Trial. Front Immunol. 2018 Apr 27;9:906. doi: 10.3389/fimmu.2018.00906. eCollection 2018.
Results Reference
derived
PubMed Identifier
24972700
Citation
Benatti FB, Miossi R, Passareli M, Nakandakare ER, Perandini L, Lima FR, Roschel H, Borba E, Bonfa E, Gualano B, de Sa Pinto AL. The effects of exercise on lipid profile in systemic lupus erythematosus and healthy individuals: a randomized trial. Rheumatol Int. 2015 Jan;35(1):61-9. doi: 10.1007/s00296-014-3081-4. Epub 2014 Jun 28.
Results Reference
derived
PubMed Identifier
23531226
Citation
Prado DM, Benatti FB, de Sa-Pinto AL, Hayashi AP, Gualano B, Pereira RM, Sallum AM, Bonfa E, Silva CA, Roschel H. Exercise training in childhood-onset systemic lupus erythematosus: a controlled randomized trial. Arthritis Res Ther. 2013 Mar 26;15(2):R46. doi: 10.1186/ar4205.
Results Reference
derived
Learn more about this trial
Exercise and Systemic Lupus Erythematosus
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