The Use of a Mobile Application to Support Physical Activity and Lifestyle Changes in Persons Living With HIV: the SMARTAPP Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Physical Fitness
研究概览
简要总结
Physical activity delays all-cause mortality in the general population and reduces the risk of cardiovascular disease (CVD), stroke, type-2 diabetes and some types of cancer (Garber et al., 2011). These diseases are associated with chronic inflammation, which is characterized by activation of inflammatory signalling pathways with abnormal production of cytokines and other mediators (Hotamisligil, 2006). Observational studies of large population cohorts have consistently shown an association between physical inactivity and low-grade systemic inflammation and interventional studies a reduction of inflammatory markers following exercise (Beavers et al., 2010).
Chronic inflammation is also a predominant feature of treated human immunodeficiency virus (HIV) infection (Lederman et al., 2013; Deeks et al., 2013). Compared to age-matched HIV-negative subjects, persons with chronic HIV infection are at higher risk to develop non-acquired immune deficiency syndrome (AIDS) related chronic diseases (Guaraldi et al., 2011), and several studies have shown an association between chronic inflammation and higher cardiovascular risk and overall mortality (Kuller et al., 2008, Duprez et al., 2012).
Recently, the investigators performed a pilot study of moderate physical activity that enrolled sedentary HIV infected subjects treated with combination antiretroviral treatment (cART), consisting of brisk walking, with or without strength exercise. Overall, after 12 weeks of training cholesterol profile and soluble and cell inflammatory markers improved significantly. However, because of the considerable individual variability in exercise responses, a program of physical activity needs be adjusted on an individual basis to be most effective. During recent years, the use of mobile technologies has been implemented for health monitoring interventions, including exercise. We hypothesized that the use of a mobile application will favour engagement to exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an improvement of physical fitness.
The investigators hypothesized that the use of a mobile application will favour engagement to exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an improvement of physical fitness. Therefore, the aim of this project is to improve health and quality of life of patients living with HIV through self-empowerment by use of an innovative mobile application, in order to assist and monitor individualized program of physical activity and diet recommendation.
OBJECTIVES
Primary To compare the improvement of physical fitness between the EG and CG groups after 16 weeks of training.
Secondary
To compare the improvement of the following characteristics between the EG and CG groups after 16 weeks of training:
- anthropometry,
- Blood lipids,
- Inflammatory markers,
- Quality of Life,
4. Mood State.
ENDPOINTS Primary The primary objective will be assessed by the proportion of subjects with an improvement from baseline of 15% of maximal oxygen consumption (O2max) through 16 weeks of training.
Secondary
The secondary endpoints will be assessed by the 16-week changes in the following measures:
- BMI and %Fat Mass,
- Blood Total-, LDL-, HDL-Cholesterol,
- Blood IL-6, hs-PCR, d-Dimer, IL-18; myostatin; T-cell activation markers,
- F12 questionnaire,
- Profile of Mood State questionnaire.
详细描述
STUDY DESIGN Multicentre, randomized, open-label, pilot study enrolling HIV-infected subjects, of age ≥18 years, with or without cART, either sedentary or already practicing mild/moderate physical activity.+
Subjects satisfying the inclusion and exclusion criteria will be randomized 1:1 to one of the following arms:
i) experimental group (EG), where participants will be trained with an exercise program for 16 weeks with the use of a smartphone application; ii) control group (CG), where participants will be trained with an exercise program for 16 weeks without smartphone application.
You will be screened for eligibility by an infectious diseases specialist and a sport medicine specialist through collection of clinical and treatment history, physical examination, routine blood screen, ECG at rest and during submaximal cycle ergometer test. Eligible patients will sign a written informed consent and will be followed-up at screening, baseline (start of the training program) and after 16 weeks of training, except for profile of mood states that will be assessed weekly
Each study visit will include: the evaluation of CDC stage, anthropometric assessment (height, weight), systolic and diastolic blood pressure, smoking status, assessment of the antiretroviral and concomitant therapies and routine laboratory tests. Additional 30 mL of peripheral blood will be withdrawn at baseline and at the end of the study (week 16) and stored in a biobank for further investigations for patients recruited from San Raffaele Hospital. The demographic, clinical, physical fitness, quality of life information will be accurately recorded at the study visits in an electronic Case Report Form (eCRF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥18 years;
- •with or without cART;
- •either sedentary or already practicing mild/moderate physical activity;
排除标准
- •any disease requiring hospitalization in the 6 weeks before enrolment;
- •medical conditions contraindicating exercise as established by a sport medicine specialist;
- •current substance or alcohol abuse.
结局指标
主要结局
Physical Fitness
时间窗: After 16 weeks of training
Improvement of 15% of maximal oxygen consumption
次要结局
- Anthropometry(After 16 weeks of training)
- Mood States(After 16 weeks of training)
- Inflammatory Markers(After 16 weeks of training)
- Blood Lipids(After 16 weeks of training)
研究者
Paola Cinque
Medical Doctor
Scientific Institute San Raffaele