Exercise is Medicine: a Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6,000
- 试验地点
- 1
- 主要终点
- office blood pressure
研究概览
简要总结
6,000 patients with HT and/or DM will be recruited to participate a 12-week EIM exercise intervention, which also involve consistent feedback and reminders using information technology (IT). The primary outcome will be improvement of blood pressure at 1-year. Other clinical outcomes will be obtained on recruitment (baseline), 12-week (immediately after EIM classes) and 1-year after recruitment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have a clinical diagnosis of primary HT and/or type II DM from clinical medical record
- •having less than 150 minutes of moderate intensity exercise per week OR having less than 75 minutes of intensive intensity exercise per week (this is set according to latest World Health Organization guideline)
- •who have used any mobile apps on their phone (because the intervention involve use of apps to monitor and remind regular exercise)
排除标准
- •patients with diagnosed chronic obstructive lung disease and recent stroke (within last 12 months)
- •Patients on 3 or more anti-hypertensive medications (on maximum or maximal tolerable doses) are excluded because these patients have resistant HT and may represent another spectrum of disease.
- •Patients with spinal cord compression, radiculopathy with active pain, or osteoarthritis of hips and knees that are on the waiting list for joint replacement surgery are excluded for safety reasons.
- •acute myocardial infarction in last 6 months
- •ongoing angina
- •uncontrolled cardiac arrhythmia
- •acute diseases including known active endocarditis/acute pulmonary embolism, pulmonary infarction, deep vein thrombosis, acute aortic dissection, acute myocarditis
- •known aortic stenosis
- •known heart failure
- •known obstructive left main coronary artery stenosis
- •uncontrolled ventricular rates
- •complete heart block
- •known hypertrophic obstructive cardiomyopathy
- •mental impairment that limit co-operation
- •resting blood pressure with systolic blood pressure >180mmHg or diastolic blood pressure >110mmHg
- •known anaemia with haemoglobin level less than 11gm/dL
- •known uncorrected electrolyte imbalance
- •known uncontrolled hyperthyroidism.
- •For DM patients, patients with proliferative diabetic retinopathy and recent retinal bleeding (in last 12 months)
研究组 & 干预措施
EIM group
This contains: A 12-week Exercise is medicine teaching class containing 6-18 patients per group (class size may be limited by social distancing policy in Hong Kong), homework are prescribed to participants to encourage regular exercise. The exercise level will be recorded by a tracker and provides feedback to the participants and physical trainer. The physical parameters such as fat percentage and blood pressure level will be feedback to the patients to encourage exercise. (If sports center are closed by the Government, the classes will be conducted online)
干预措施: exercise is medicine (Behavioral)
结局指标
主要结局
office blood pressure
时间窗: Change from Baseline Systolic Blood Pressure at 3 months
office systolic blood pressure
次要结局
- body fat percentage(baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study))
- serum lipid level(baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study))
- international physical activity questionnaire- short form(baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study))
- body mass index(baseline, 3-month after recruitment (immediate after EIM class), 12-month after recruitment (end-of-study))
- office blood pressure(baseline, 12-month after recruitment (end-of-study))
研究者
Lee Kam Pui
Clinical Assistant Professor
Chinese University of Hong Kong