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Exercise and Arterial Stiffness in Systemic Lupus Erythematosus (EJERCITALES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date August 7, 2017
Actual Study Start Date  ICMJE April 12, 2017
Actual Primary Completion Date July 21, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • 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
  • Endothelial dysfunction [ Time Frame: Change from baseline to week 12 ]
    Intercellular Adhesion Molecule 1 (ICAM-1)
  • Oxidative stress [ Time Frame: Change from baseline to week 12 ]
    Myeloperoxidase (MPO)
  • Glucose [ Time Frame: Change from baseline to week 12 ]
    Blood glucose levels
  • Insulin [ Time Frame: Change from baseline to week 12 ]
    Blood insulin levels
  • Homeostasis Model Assessment of Insulin Resistance [ Time Frame: Change from baseline to week 12 ]
    Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
  • Glycated hemoglobin [ Time Frame: Change from baseline to week 12 ]
    Glycated hemoglobin (HbA1c %) obtained from blood sample
  • Lipid Profile [ Time Frame: Change from baseline to week 12 ]
    Triglycerides, total cholesterol total, LDL cholesterol and HDL cholesterol
  • Cardiorespiratory fitness [ Time Frame: Change from baseline to week 12 ]
    Assessed by the modified Bruce Test on a treadmill
  • 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]
  • Flexibility [ Time Frame: Change from baseline to week 12 ]
    Assessed by the back scratch test (from the Senior Fitness Test battery)
  • 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)
  • 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)
  • 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])
  • Resting Heart Rate Variability [ Time Frame: Change from baseline to week 12 ]
    Measured with a V800 Polar heart rate monitor
  • Physical activity [ Time Frame: Change from baseline to week 12 ]
    Self-reported physical activity assessed by the International Physical Activity Questionnaire (IPAQ)
  • Markers of blood coagulation [ Time Frame: Change from baseline to week 12 ]
    Fibrinogen and homocystein
  • Blood markers of renal function [ Time Frame: Change from baseline to week 12 ]
    Urea, creatinine, and Glomerular Filtration Rate (in blood sample)
  • Microalbuminuria [ Time Frame: Change from baseline to week 12 ]
    Measured in flesh urine sample
  • Proteinuria [ Time Frame: Change from baseline to week 12 ]
    Measured in flesh urine sample
  • Blood count [ Time Frame: Change from baseline to week 12 ]
    Red blood cells, hemoglobin, medium corpuscular volume, leukocytes, and platelets
  • Health-related quality of life [ Time Frame: Change from baseline to week 12 ]
    Assessed by the 36-item Short Form Health Survey (SF-36)
  • Depression [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Beck Depression Inventory second edition (BDI-II)
  • Fatigue [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Multidimensional Fatigue Inventory (MFI-20)
  • Sleep quality [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Pittsburgh Sleep Quality Index (PSQI)
  • Sedentary behavior [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Sedentary Behavior Questionnaire (SBQ)
  • Adherence to the Mediterranean Diet [ Time Frame: Change from baseline to week 12 ]
    Assessed by food frequency questionnaire
  • Perceived stress [ Time Frame: Change from baseline to week 12 ]
    Assessed by the Perceived Stress Scale (PES)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
  • 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
  • Endothelial dysfunction [ Time Frame: Change from baseline to week 12 ]
    Intercellular Adhesion Molecule 1 (ICAM-1)
  • Oxidative stress [ Time Frame: Change from baseline to week 12 ]
    Myeloperoxidase (MPO)
  • Glucose [ Time Frame: Change from baseline to week 12 ]
    Blood glucose levels
  • Insulin [ Time Frame: Change from baseline to week 12 ]
    Blood insulin levels
  • Homeostasis Model Assessment of Insulin Resistance [ Time Frame: Change from baseline to week 12 ]
    Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
  • Glycated hemoglobin [ Time Frame: Change from baseline to week 12 ]
    Glycated hemoglobin (HbA1c %) obtained from blood sample
  • Lipid Profile [ Time Frame: Change from baseline to week 12 ]
    Triglycerides, total cholesterol total, LDL cholesterol and HDL cholesterol
  • Cardiorespiratory fitness [ Time Frame: Change from baseline to week 12 ]
    Assessed by the modified Bruce Test on a treadmill
  • 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]
  • Flexibility [ Time Frame: Change from baseline to week 12 ]
    Assessed by the back scratch test (from the Senior Fitness Test battery)
  • 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)
  • 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)
  • 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])
  • Resting Heart Rate Variability [ Time Frame: Change from baseline to week 12 ]
    Measured with a V800 Polar heart rate monitor
  • Physical activity [ Time Frame: Change from baseline to week 12 ]
    Self-reported physical activity assessed by the International Physical Activity Questionnaire (IPAQ)
  • Markers of blood coagulation [ Time Frame: Change from baseline to week 12 ]
    Fibrinogen and homocystein
  • Blood markers of renal function [ Time Frame: Change from baseline to week 12 ]
    Urea, creatinine, and Glomerular Filtration Rate (in blood sample)
  • Microalbuminuria [ Time Frame: Change from baseline to week 12 ]
    Measured in flesh urine sample
  • Proteinuria [ Time Frame: Change from baseline to week 12 ]
    Measured in flesh urine sample
  • Blood count [ Time Frame: Change from baseline to week 12 ]
    Red blood cells, hemoglobin, medium corpuscular volume, leukocytes, and platelets
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise and Arterial Stiffness in Systemic Lupus Erythematosus
Official Title  ICMJE Effects of an Aerobic Exercise Intervention Program on Arterial Stiffness and Inflammation in Women With Systemic Lupus Erythematosus
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Exercise
    12-weeks aerobic exercise intervention
    Intervention: Behavioral: Aerobic exercise
  • No Intervention: Control
    Usual care, with recommendations for a healthy lifestyle.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2017)
58
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2017)
60
Actual Study Completion Date  ICMJE July 21, 2017
Actual Primary Completion Date July 21, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03107442
Other Study ID Numbers  ICMJE PI-0525-2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party José Antonio Vargas Hitos, Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Study Sponsor  ICMJE Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: José A. Vargas-Hitos, MD, Ph.D. Virgen de las Nieves University Hospital, Granada, Spain
PRS Account Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP