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临床试验/NCT03853018
NCT03853018已完成不适用

The Effectiveness of Consumer Wearable Activity Trackers to Reduce Sedentary Behaviour and Improve Health-related Outcomes in Sedentary Adults

Hasselt University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
sitting time

研究概览

简要总结

This study evaluates the effectiveness of consumer wearable activity trackers to reduce sedentary behaviour and the impact on cardiometabolic health.

详细描述

Chronic non-communicable diseases (NCDs), including cardiovascular diseases, cancer, chronic respiratory diseases and diabetes, are an important public health concern worldwide. Physical inactivity is one of the major contributing factors which is highly correlated with the prevalence of NCDs. On the other hand, it is well known that increased physical activity has significant health benefits and is associated with the prevention and delayed onset of many NCDs. Given the important role of physical activity in the prevention and management of NCDs it is thus important to promote physical activity. Hence, to date a multitude of physical activity recommendations and many supervised training interventions and rehabilitation programs are available to encourage physical activity in the global population. Despite this, a recent report from the World Health Organization (WHO) indicates that 23% of the adult and 80% of the adolescent population remains physically inactive. Here, long-term compliance to adequate physical activity and a healthy life style appears to be one of the main barriers explaining this discrepancy. Consequently, any strategy that improves long term adherence to adequate daily physical activity and a healthy life style, especially in an NCD population, is worthwhile investigating. In this respect and following the recent use of accelerometer-based remote monitoring of physical activity in chronic disease patients, consumer wearable activity trackers may be such a strategy. So far, consumer wearable activity trackers have been investigated mainly in the sports community. Here CWATs are used for self-monitoring and providing continuous sport performance and health related information to athletes and coaches. Interestingly, the self-management, motivational and goal setting properties of these commercially available devices may also help patients with NCDs to engage in long-term physical activity under free-living conditions in a home-based setting. Despite the widespread use of these wearables their feasibility and effectiveness on physical activity (compliance) and generic health-related outcomes, including weight, body mass index (BMI), systemic blood pressure and glycemic index, especially in patients with NCDs is not fully clear.

Therefore, the aim of this study is to investigate the effectiveness of CWATs to promote physical activity levels and cardiometabolic health in sedentary adults. A better understanding to what extent CWATs can actually improve physical activity (compliance) and health outcomes is important to increase the effectiveness and quality of health care in chronic disease populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Sedentary adults
  • 40-75 years,
  • <7500steps/day,
  • sitting time of >10h/day,
  • BMI 23-30 kg/m2,
  • body fat percentage: male: 18-25%, female: 25-35%
  • HbA1c < 6.0%

排除标准

  • pregnancy,
  • regularly (>150 min per week during the last four months) engaged in moderate-to-vigorous intensity exercise,
  • any known contradiction for physical activity,
  • systolic blood pressure >160mmHg,
  • diastolic blood pressure >100mmHg
  • more than 20 alcohol consumptions per week,
  • plans to follow a weight reduction program with the aid of an energy restriction diet or a physical intervention program during the study period,
  • participants diagnosed with any known chronic disease.

结局指标

主要结局

sitting time

时间窗: week 12

sedentary behaviour will be quantified using the activPAL3™ activity monitor.

Steps per day

时间窗: week 12

Physical activity will be quantified using the activPAL3™ activity monitor.

次要结局

  • Concentration of soluble vascular cell adhesion molecule-1 (sVCAM-1),(week 12)
  • Concentration of soluble E-selectin (sE-selectin).(week 12)
  • A six-minute walk test(week 12)
  • body weight(week 12)
  • Concentration of total cholesterol(baseline)
  • total cholesterol(week 12)
  • Concentration of interleukin 6 (IL-6),(week 12)
  • Concentration of tumor necrosis factor-alpha (TNF-α),(week 12)
  • Area under the curve of glucose concentrations(week 12)
  • Height(week 12)
  • Minute ventilation (VE)(week 12)
  • Heart rate (HR)(week 12)
  • Concentration of glucose(week 12)
  • Concentration of low density lipoprotein cholesterol (LDL-cholesterol)(week 12)
  • Concentration of triglyceride(week 12)
  • Concentration of glycated haemoglobin (HbA1c)(week 12)
  • Concentration of C-reactive protein (CRP)(week 12)
  • Concentration of soluble intercellular adhesion molecule 1 (sICAM-1)(week 12)
  • Homeostatic model assessment for insulin resistance (HOMA-IR)(week 12)
  • Whole-body insulin sensitivity index (ISI)(week 12)
  • Cardiac autonomic function(week 12)
  • Oxygen uptake (VO2)(week 12)
  • Tidal volume (Vt)(week 12)
  • Breathing frequency (BF)(week 12)
  • DEXA (Dual Energy X-Ray)(week 12)
  • Concentration of Insuline(week 12)
  • Concentration of high density lipoprotein cholesterol (HDL-cholesterol)(week 12)
  • Area under the curve of insulin concentrations(week 12)
  • Concentration of uric acid(week 12)
  • Concentration of serum amyloid A (SAA)(week 12)
  • Vascular endothelial function(week 12)
  • Carbon dioxide output (VCO2)(week 12)
  • Equivalents for carbon dioxide production (VE/VCO2)(week 12)
  • Respiratory gas exchange ratio (RER)(week 12)
  • Insulinogenic index(week 12)
  • Systolic and Diastolic Blood pressure(week 12)
  • Equivalents for oxygen uptake (VE/VO2)(week 12)
  • Total calorie intake(week 12)
  • Macronutrient content(week 12)
  • Relative autonomy index(week 12)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bert Op't Eijnde

Principal Investigator

Hasselt University

研究点 (2)

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