The Development and Application of a Toolset for Monitoring Personalized Physical Activity and Evaluation of Its Effectiveness in Individuals With Metabolic Syndrome

Vilnius University2 个研究点分布在 1 个国家目标入组 200 人开始时间: 2017年8月21日最近更新: 2022年10月25日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Vilnius University
入组人数: 200
试验地点: 2
主要终点: Changes in mean blood pressure in the aorta, mean blood pressure in the brachial artery and pulse pressure in the aorta

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A prospective intervention study to evaluate the effectiveness of the developed toolset for remote physical activity monitoring to improve arterial stiffness and other cardiometabolic parameters and to increase physical activity levels and the compliance to the prescribed exercise in individuals with metabolic syndrome.

详细描述

At first, all subjects of the prospective study participated in the 2-month outpatient aerobic exercise program, which consisted of 40 aerobic training sessions on a cycle ergometer 5 times/week for 40 min. During all training sessions, heart rate was maintained at the targeted level, which was obtained individually by cardiopulmonary test. After 2 months, during individual motivational consultations, all participants received recommendations for home-based training and were randomly allocated to the intervention or the control group. Then only the intervention group subjects participated in the 6-month home-based aerobic exercise program using a wearable heart rate monitor, which was connected to the smartphone via Bluetooth. The intervention group subjects used a smartphone application created for the study. The control group participants were asked to exercise at home for 6 months without wearables and smartphone application. The evaluation of the study participants was performed at baseline (1st visit), after 2 months (2nd visit) and after 8 months (3rd visit).

研究设计

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

入排标准

年龄范围: 40 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Males (40-55 years) and females (50-65 years) with metabolic syndrome, having at least three of the following five criteria: hypertriglyceridemia (triglycerides ≥ 1.7 mmol/l); high-density lipoprotein cholesterol ≤ 1.03 mmol/l for men or ≤ 1.29 mmol/l for women; abdominal obesity (waist circumference > 102 cm for men and > 88 cm for women); elevated blood pressure (systolic blood pressure ≥ 130 mmHg and/or diastolic blood pressure ≥ 85 mmHg or current use of antihypertensive drugs); elevated fasting plasma glucose ≥ 5.6 mmol/l;

排除标准

•Patients with overt cardiovascular disease (previous myocardial infarction, coronary artery bypass surgery, percutaneous coronary intervention, previous stroke)
•Patients with severe heart failure symptoms, uncontrolled hypertension
•Patients with urinary tract infection or fever for another unknown reason
•Patients who have actively exercised in the last 24 hours
•Pregnant women

结局指标

主要结局

Changes in mean blood pressure in the aorta, mean blood pressure in the brachial artery and pulse pressure in the aorta