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Exercise and Arterial Stiffness in Systemic Lupus Erythematosus (EJERCITALES)

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ClinicalTrials.gov Identifier: NCT03107442
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : August 7, 2017
Sponsor:
Information provided by (Responsible Party):
José Antonio Vargas Hitos, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

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
Systemic Lupus Erythematosus Behavioral: Aerobic exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of an Aerobic Exercise Intervention Program on Arterial Stiffness and Inflammation in Women With Systemic Lupus Erythematosus
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : July 21, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Arterial stiffness [ Time Frame: 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 :
  1. Markers of inflammation [ Time Frame: 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

  2. Endothelial dysfunction [ Time Frame: Change from baseline to week 12 ]
    Intercellular Adhesion Molecule 1 (ICAM-1)

  3. Oxidative stress [ Time Frame: Change from baseline to week 12 ]
    Myeloperoxidase (MPO)

  4. Glucose [ Time Frame: Change from baseline to week 12 ]
    Blood glucose levels

  5. Insulin [ Time Frame: Change from baseline to week 12 ]
    Blood insulin levels

  6. Homeostasis Model Assessment of Insulin Resistance [ Time Frame: Change from baseline to week 12 ]
    Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)

  7. Glycated hemoglobin [ Time Frame: Change from baseline to week 12 ]
    Glycated hemoglobin (HbA1c %) obtained from blood sample

  8. Lipid Profile [ Time Frame: Change from baseline to week 12 ]
    Triglycerides, total cholesterol total, LDL cholesterol and HDL cholesterol

  9. Cardiorespiratory fitness [ Time Frame: Change from baseline to week 12 ]
    Assessed by the modified Bruce Test on a treadmill

  10. Muscle strength [ Time Frame: Change from baseline to week 12 ]
    Assessed by isometric handgrip dynamometry (hand grip strength test [TKK 5401, Takei Scientific Instruments, Tokyo, Japan]

  11. Flexibility [ Time Frame: Change from baseline to week 12 ]
    Assessed by the back scratch test (from the Senior Fitness Test battery)

  12. Waist and hip circumference [ Time Frame: Change from baseline to week 12 ]
    Waist and hip circumferences (cm), and calculate waist-to-height ratio (waist in cm divided hip in cm)

  13. Body mass index [ Time Frame: Change from baseline to week 12 ]
    Body mass index (BMI, the weight in kilograms divided by the square of the height in meters)

  14. Body composition [ Time Frame: Change from baseline to week 12 ]
    Percent body fat, percent fat free mass, and percent muscle mass (assessed by InBody 270 [Biospace Co., USA])

  15. Resting Heart Rate Variability [ Time Frame: Change from baseline to week 12 ]
    Measured with a V800 Polar heart rate monitor

  16. Physical activity [ Time Frame: Change from baseline to week 12 ]
    Self-reported physical activity assessed by the International Physical Activity Questionnaire (IPAQ)

  17. Markers of blood coagulation [ Time Frame: Change from baseline to week 12 ]
    Fibrinogen and homocystein

  18. Blood markers of renal function [ Time Frame: Change from baseline to week 12 ]
    Urea, creatinine, and Glomerular Filtration Rate (in blood sample)

  19. Microalbuminuria [ Time Frame: Change from baseline to week 12 ]
    Measured in flesh urine sample

  20. Proteinuria [ Time Frame: Change from baseline to week 12 ]
    Measured in flesh urine sample

  21. Blood count [ Time Frame: Change from baseline to week 12 ]
    Red blood cells, hemoglobin, medium corpuscular volume, leukocytes, and platelets

  22. Health-related quality of life [ Time Frame: Change from baseline to week 12 ]
    Assessed by the 36-item Short Form Health Survey (SF-36)

  23. Depression [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Beck Depression Inventory second edition (BDI-II)

  24. Fatigue [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Multidimensional Fatigue Inventory (MFI-20)

  25. Sleep quality [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Pittsburgh Sleep Quality Index (PSQI)

  26. Sedentary behavior [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Sedentary Behavior Questionnaire (SBQ)

  27. Adherence to the Mediterranean Diet [ Time Frame: Change from baseline to week 12 ]
    Assessed by food frequency questionnaire

  28. Perceived stress [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Perceived Stress Scale (PES)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology criteria (presenting at least 4 classification criteria).
  • Follow-up of at least 12 months at our Unit.
  • Clinical and treatment stability during the 6 months prior to the study.
  • Not performing regular exercise (defined as < 60min/week of structured exercise)

Exclusion Criteria:

  • Biological treatment in the previous 6 months or to need prednisone dosis >10 mg/day.
  • Background of clinical cardiovascular disease in the last year.
  • To present contraindications to perform exercise.
  • Other associated rheumatic conditions.
  • Pregnancy.
  • Acute renal failure.
  • Cardiac or pulmonary involvement.
  • Body Mass Index > 35
  • Not being able to read, understand and sign written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03107442


Locations
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Spain
Virgen de las Nieves University Hospital
Granada, Spain, 18014
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Investigators
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Principal Investigator: José A. Vargas-Hitos, MD, Ph.D. Virgen de las Nieves University Hospital, Granada, Spain
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Responsible Party: José Antonio Vargas Hitos, José A. Vargas-Hitos, MD, PhD, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
ClinicalTrials.gov Identifier: NCT03107442    
Other Study ID Numbers: PI-0525-2016
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by José Antonio Vargas Hitos, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental:
Arterial stiffness
Markers of Inflammation
Exercise
Physical fitness
Cardiovascular risk
Autoimmune diseases
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases