Effects of an Aerobic Exercise Intervention Program on Arterial Stiffness and Inflammation in Women With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Arterial Stiffness
研究概览
简要总结
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.
详细描述
2. Design and Protocol Registration This non-randomized controlled trial was registered at clinicaltrials.gov [NCT03107442] on 11 April 2017, before the enrolment of participants started (i.e., on 12 April), and no deviations occurred regarding the primary outcome and the secondary outcomes analyzed here.
3. Setting and Eligibility Criteria Participants were recruited from the Systemic Autoimmune Diseases Unit of the "Virgen de las Nieves" and the "San Cecilio" University Hospitals. Women with a diagnosis of SLE according to the ACR criteria [26], a follow-up of 12 months, clinical and treatment stability during the previous six months, and not performing regular exercise (defined as 60 min/week of structured exercise) were included. Exclusion criteria were to have been under biological treatment in the previous six months or to need a prednisone dose of >10 mg/day; a background of CVD in the previous year; to present contraindications to perform exercise; other associated rheumatic conditions; pregnancy; active acute or chronic infection; neoplasms; acute renal failure; cardiac or pulmonary involvement; body mass index (BMI) >35; or not being able to read, understand, and sign written informed consent.
All participants received detailed information about the study procedures, and signed written informed consent. The Research Ethics Committee of Granada approved the protocol on 11 November 2016 (reference No.: 10/2016).
4. Procedures A telephone screening was conducted. Potentially eligible participants were invited to a personal screening and, if included, day 1 of the baseline examination was performed. The baseline examination comprised two assessment days. On day 1, pulse wave velocity (PWV) was assessed. Thereafter, cardiorespiratory fitness testing was performed, and socio-demographic and clinical information was collected. On day 2 (i.e., between two and four days after day 1), 8-h fasting blood samples were collected between 8:00 a.m. and 10:00 a.m. This article follows the TREND statement for improving the reporting of non-randomized experiments of behavioral and public health interventions (downloadable at EQUATOR Network: https://goo.gl/ZSyLrj; Supplementary Table S1) [27]. The funding source had no role in the study.
5. Methods 5.1. Interventions 5.1. 1. Exercise Group To maximize transparency and replicability, the exercise program described in this manuscript follows the Consensus on Exercise Reporting Template (CERT; Supplementary Table S2) [28]. The patients assigned to exercise performed two 75-min sessions per week during a total of 12 weeks (i.e., 24 sessions) of moderate to vigorous intensity aerobic exercise on a treadmill (BH, Serie i.RC12 Dual, Vitoria-Gasteiz, Spain) from 24 April to 14 July 2017. The sessions took place in a quiet room of the "Virgen de las Nieves" Hospital, Granada (Spain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Arterial Stiffness
时间窗: value at 12 weeks minus value at baseline
Pulse wave velocity assessed with Mobil-OGraph ® 24h pulse wave analysis monitor (IEM GmbH, Stolberg, Germany)
次要结局
- Markers of Inflammation(Change from baseline to week 12)
- Flexibility(Change from baseline to week 12)
- Insulin(Change from baseline to week 12)
- Homeostasis Model Assessment of Insulin Resistance(Change from baseline to week 12)
- Glycated Hemoglobin(Change from baseline to week 12)
- Glucose(Change from baseline to week 12)
- BMI(Change from baseline to week 12)
- Coagulation(Change from baseline to week 12)
- Fatigue(Change from baseline to week 12)
- Sedentary Behavior(Change from baseline to week 12)
- Perceived Stress(Change from baseline to week 12)
- Lipid(Change from baseline to week 12)
- Cardiorespiratory Fitness(Change from baseline to week 12)
- Muscle Strength(Change from baseline to week 12)
- Sleep Quality(Change from baseline to week 12)
- Waist and Hip Circumference(Change from baseline to week 12)
- Renal Function(Change from baseline to week 12)
- Health-related Quality of Life(Change from baseline to week 12)
- Depression(Change from baseline to week 12)
- Adherence to the Mediterranean Diet(Change from baseline to week 12)
研究者
José Antonio Vargas Hitos
José A. Vargas-Hitos, MD, PhD
Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental