Exercise and Arterial Stiffness in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

— EJERCITALES  

Official title:

Effects of an Aerobic Exercise Intervention Program on Arterial Stiffness and Inflammation in Women With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107442
• Other study ID #: PI-0525-2016
• Status: Completed
• Phase: N/A
• First received: March 30, 2017
• Last updated: August 4, 2017
• Start date: April 12, 2017
• Est. completion date: July 21, 2017

Study information

• Verified date: August 2017
• Source: Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: July 21, 2017
• Est. primary completion date: July 21, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

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.

Locations

Country	Name	City	State
Spain	Virgen de las Nieves University Hospital	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial stiffness	Pulse wave velocity assessed with Mobil-OGraph ® 24h pulse wave analysis monitor (IEM GmbH, Stolberg, Germany)	Change from baseline to week 12
Secondary	Markers of inflammation	Interleukin 6 (IL-6), Tumor Necrosis Factor alpha (TNF-a), high sensitivity C-Reactive Protein (hs-CRP), and light chains	Change from baseline to week 12
Secondary	Endothelial dysfunction	Intercellular Adhesion Molecule 1 (ICAM-1)	Change from baseline to week 12
Secondary	Oxidative stress	Myeloperoxidase (MPO)	Change from baseline to week 12
Secondary	Glucose	Blood glucose levels	Change from baseline to week 12
Secondary	Insulin	Blood insulin levels	Change from baseline to week 12
Secondary	Homeostasis Model Assessment of Insulin Resistance	Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)	Change from baseline to week 12
Secondary	Glycated hemoglobin	Glycated hemoglobin (HbA1c %) obtained from blood sample	Change from baseline to week 12
Secondary	Lipid Profile	Triglycerides, total cholesterol total, LDL cholesterol and HDL cholesterol	Change from baseline to week 12
Secondary	Cardiorespiratory fitness	Assessed by the modified Bruce Test on a treadmill	Change from baseline to week 12
Secondary	Muscle strength	Assessed by isometric handgrip dynamometry (hand grip strength test [TKK 5401, Takei Scientific Instruments, Tokyo, Japan]	Change from baseline to week 12
Secondary	Flexibility	Assessed by the back scratch test (from the Senior Fitness Test battery)	Change from baseline to week 12
Secondary	Waist and hip circumference	Waist and hip circumferences (cm), and calculate waist-to-height ratio (waist in cm divided hip in cm)	Change from baseline to week 12
Secondary	Body mass index	Body mass index (BMI, the weight in kilograms divided by the square of the height in meters)	Change from baseline to week 12
Secondary	Body composition	Percent body fat, percent fat free mass, and percent muscle mass (assessed by InBody 270 [Biospace Co., USA])	Change from baseline to week 12
Secondary	Resting Heart Rate Variability	Measured with a V800 Polar heart rate monitor	Change from baseline to week 12
Secondary	Physical activity	Self-reported physical activity assessed by the International Physical Activity Questionnaire (IPAQ)	Change from baseline to week 12
Secondary	Markers of blood coagulation	Fibrinogen and homocystein	Change from baseline to week 12
Secondary	Blood markers of renal function	Urea, creatinine, and Glomerular Filtration Rate (in blood sample)	Change from baseline to week 12
Secondary	Microalbuminuria	Measured in flesh urine sample	Change from baseline to week 12
Secondary	Proteinuria	Measured in flesh urine sample	Change from baseline to week 12
Secondary	Blood count	Red blood cells, hemoglobin, medium corpuscular volume, leukocytes, and platelets	Change from baseline to week 12
Secondary	Health-related quality of life	Assessed by the 36-item Short Form Health Survey (SF-36)	Change from baseline to week 12
Secondary	Depression	Assessed by the Beck Depression Inventory second edition (BDI-II)	Change from baseline to week 12
Secondary	Fatigue	Assessed by the Multidimensional Fatigue Inventory (MFI-20)	Change from baseline to week 12
Secondary	Sleep quality	Assessed by the Pittsburgh Sleep Quality Index (PSQI)	Change from baseline to week 12
Secondary	Sedentary behavior	Assessed by the Sedentary Behavior Questionnaire (SBQ)	Change from baseline to week 12
Secondary	Adherence to the Mediterranean Diet	Assessed by food frequency questionnaire	Change from baseline to week 12
Secondary	Perceived stress	Assessed by the Perceived Stress Scale (PES)	Change from baseline to week 12