Effectiveness and Mechanisms of Isometric Resistance Exercise to Reduce Blood Pressure in a Chinese Population: a Pilot Randomized-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- rate of recruitment
研究概览
简要总结
Background: Isometric resistance exercises (IREs) have great potential to improve blood pressure (BP) control.
Methods: This is a pilot randomized controlled trial that will involve 50 patients with hypertension (HT) who do not meet the current physical activity guidelines defined by the World Health Organization. Participants will be randomly assigned in a 1:1 ratio using stratified and blocked randomization to either the IRE (wall squat) group or stretching exercise (active control) group. A well-structured, widely accepted, and validated 24-week wall squat program (2 minutes per exercise, 2 minutes of rest between sets, and 3 sessions per week) will be implemented, as it has been commonly used in previous research. All patients will be followed up for 24 weeks. Control group will receive exact same treatment except that IRE is replaced by frequency-matched and time-matched stretching exercise. The primary outcome measure will be rate of recruitment. Secondary outcomes will include BP parameters from 24-hour ambulatory BP monitoring
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a suboptimal daytime SBP of >135-160 mmHg on a 24-h ABPM
- •reported no regular physical activity or less than that recommended for adults by the World Health Organization (e.g. <150 minutes of moderate-intensity aerobic exercise per week);
- •on stable doses of anti-HT medication(s) for ≥4 weeks if the patient is receiving drug treatments
- •agree for no drug changes during the intervention period (24 weeks);
排除标准
- •cannot provide informed consent
- •unwillingness to repeat ABPM
- •relative contraindications to ABPM (i.e. diagnosed atrial fibrillation, nighttime workers, occupational drivers, or patients with bleeding tendencies)
- •severe osteoarthritis pending knee replacement surgery
- •known secondary HT
- •use of ≥3 anti-HT medications at maximum doses or ≥4 anti-HT medications
- •SBP or DBP are >160 mmHg or >100 mmHg, respectively, on ABPM
- •pregnancy/breastfeeding
- •active malignancy
结局指标
主要结局
rate of recruitment
时间窗: through study completion, an average of 1 year
number of people recruited per month
次要结局
- Blood pressure parameters(24-week after recruitment)
- flow-mediated velocity (FMD)(24-week after recruitment)
- Carotid-femoral pulse wave velocity(24-week after recruitment)
研究者
Lee Kam Pui
clinical associate professor
Chinese University of Hong Kong