EJERCITALES: Exercise and Arterial Stiffness in Systemic Lupus Erythematosus
Study Details
Study Description
Brief Summary
Patients with Systemic Lupus Erythematosus (SLE) have increased arterial stiffness, which leads to cardiovascular diseases (CVD) of arteriosclerotic origin, which are the main cause of mortality in these patients. Exercise is a modifiable factor that reduces cardiovascular mortality and associated risk factors in the general population. Preliminary studies suggest that exercise may improve endothelial function and lipid profile in patients with SLE. However, whether meeting the international physical activity guidelines from the American College of Sports Medicine (ACSM; i.e. ≥150 min / week of moderate to vigorous intensity physical activity) can improve arterial stiffness (subclinical atherosclerosis marker) and inflammation is unknown.
The primary aim of this study is to assess the effect of an exercise program based on meeting the ACSM physical activity guidelines on arterial stiffness and inflammation in patients with SLE.
The secondary aim is to assess the effect of an exercise program based on meeting the ACSM physical activity guidelines on endothelial function, oxidative stress, as well as other cardiometabolic risk factors, physical fitness, health-related quality of life, and other psychosocial outcomes.
Our hypothesis is that meeting the ACSM guidelines will improve arterial stiffness and inflammation in patients with SLE.
The study is a non-randomized clinical trial. To minimize selection bias, participants in the intervention and control groups will be matched by age, BMI, and disease activity (SLEDAI), which are important contributors to arterial stiffness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Exercise 12-weeks aerobic exercise intervention |
Behavioral: Aerobic exercise
12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous [40-85% of the individual's heart rate reserve] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.
|
| No Intervention: Control Usual care, with recommendations for a healthy lifestyle. |
Outcome Measures
Primary Outcome Measures
- Arterial stiffness [Change from baseline to week 12]
Pulse wave velocity assessed with Mobil-OGraph ® 24h pulse wave analysis monitor (IEM GmbH, Stolberg, Germany)
Secondary Outcome Measures
- Markers of inflammation [Change from baseline to week 12]
Interleukin 6 (IL-6), Tumor Necrosis Factor alpha (TNF-α), high sensitivity C-Reactive Protein (hs-CRP), and light chains
- Endothelial dysfunction [Change from baseline to week 12]
Intercellular Adhesion Molecule 1 (ICAM-1)
- Oxidative stress [Change from baseline to week 12]
Myeloperoxidase (MPO)
- Glucose [Change from baseline to week 12]
Blood glucose levels
- Insulin [Change from baseline to week 12]
Blood insulin levels
- Homeostasis Model Assessment of Insulin Resistance [Change from baseline to week 12]
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
- Glycated hemoglobin [Change from baseline to week 12]
Glycated hemoglobin (HbA1c %) obtained from blood sample
- Lipid Profile [Change from baseline to week 12]
Triglycerides, total cholesterol total, LDL cholesterol and HDL cholesterol
- Cardiorespiratory fitness [Change from baseline to week 12]
Assessed by the modified Bruce Test on a treadmill
- Muscle strength [Change from baseline to week 12]
Assessed by isometric handgrip dynamometry (hand grip strength test [TKK 5401, Takei Scientific Instruments, Tokyo, Japan]
- Flexibility [Change from baseline to week 12]
Assessed by the back scratch test (from the Senior Fitness Test battery)
- Waist and hip circumference [Change from baseline to week 12]
Waist and hip circumferences (cm), and calculate waist-to-height ratio (waist in cm divided hip in cm)
- Body mass index [Change from baseline to week 12]
Body mass index (BMI, the weight in kilograms divided by the square of the height in meters)
- Body composition [Change from baseline to week 12]
Percent body fat, percent fat free mass, and percent muscle mass (assessed by InBody 270 [Biospace Co., USA])
- Resting Heart Rate Variability [Change from baseline to week 12]
Measured with a V800 Polar heart rate monitor
- Physical activity [Change from baseline to week 12]
Self-reported physical activity assessed by the International Physical Activity Questionnaire (IPAQ)
- Markers of blood coagulation [Change from baseline to week 12]
Fibrinogen and homocystein
- Blood markers of renal function [Change from baseline to week 12]
Urea, creatinine, and Glomerular Filtration Rate (in blood sample)
- Microalbuminuria [Change from baseline to week 12]
Measured in flesh urine sample
- Proteinuria [Change from baseline to week 12]
Measured in flesh urine sample
- Blood count [Change from baseline to week 12]
Red blood cells, hemoglobin, medium corpuscular volume, leukocytes, and platelets
- Health-related quality of life [Change from baseline to week 12]
Assessed by the 36-item Short Form Health Survey (SF-36)
- Depression [Change from baseline to week 12]
Assessed by the Beck Depression Inventory second edition (BDI-II)
- Fatigue [Change from baseline to week 12]
Assessed by the Multidimensional Fatigue Inventory (MFI-20)
- Sleep quality [Change from baseline to week 12]
Assessed by the Pittsburgh Sleep Quality Index (PSQI)
- Sedentary behavior [Change from baseline to week 12]
Assessed by the Sedentary Behavior Questionnaire (SBQ)
- Adherence to the Mediterranean Diet [Change from baseline to week 12]
Assessed by food frequency questionnaire
- Perceived stress [Change from baseline to week 12]
Assessed by the Perceived Stress Scale (PES)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology criteria (presenting at least 4 classification criteria).
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Follow-up of at least 12 months at our Unit.
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Clinical and treatment stability during the 6 months prior to the study.
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Not performing regular exercise (defined as < 60min/week of structured exercise)
Exclusion Criteria:
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Biological treatment in the previous 6 months or to need prednisone dosis >10 mg/day.
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Background of clinical cardiovascular disease in the last year.
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To present contraindications to perform exercise.
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Other associated rheumatic conditions.
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Pregnancy.
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Acute renal failure.
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Cardiac or pulmonary involvement.
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Body Mass Index > 35
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Not being able to read, understand and sign written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virgen de las Nieves University Hospital | Granada | Spain | 18014 |
Sponsors and Collaborators
- Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Investigators
- Principal Investigator: José A. Vargas-Hitos, MD, Ph.D., Virgen de las Nieves University Hospital, Granada, Spain
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI-0525-2016