A Nurse Led Intervention to Promote Physical Activity in Sedentary Older Adults With Cardio-vascular Risk Factors in the Outpatient Setting - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Change in total body weight
研究概览
简要总结
Regular physical activity should be the essence of treatment in patients with cardiovascular risk factors. Unfortunately, these interventions are usually insufficiently promoted and therefore have only limited efficacy. The aim of the study was to determine the benefits of nurse led intervention to promote physical activity in sedentary older adults with cardio-vascular risk factors in the outpatient setting. Eligible patients are randomized in a 1:1 fashion to receive nurse led tutorial on life-style modification including pedometer hand-out with a daily goal of at least 7000 steps and supporting phone calls (study group) or without a goal or calls (control group). The primary end-point of the study is change in body weight. Secondary end-points include changes in resting heart rate, systolic and diastolic blood pressure, total cholesterol and fasting glucose and clinical outcomes at 3 months follow-up.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sedentary lifestyle defined as mean walking distance per day of no more than 3 km as reported by the patients;
- •history of at least one of the following conditions: obesity (defined as body mass index ≥30 for I st degree obesity, ≥35 for second degree obesity and ≥40 for third degree obesity), hypertension, diabetes mellitus, dyslipidemia, stable coronary artery disease with or without prior myocardial infarction, peripheral arterial disease, stable arrhythmias, heart failure and/or prior stroke.
排除标准
- •unstable clinical condition (in the form of unstable coronary artery disease or peripheral arterial disease, unstable heart failure or unstable arrhythmias);
- •inability to undertake physical activity due to orthopedic reasons or other disabilities;
- •planned changes in pharmacological treatment during the study period;
- •lack of will to participate in the study and to sign the the written informed consent for the participation in the study.
结局指标
主要结局
Change in total body weight
时间窗: 3 months
次要结局
- Change in body mass index (BMI)(3 months)
- Change in waist circumference(3 months)
- Change in resting heart rate(3 months)
- Change in resting blood pressure(3 months)
- Change in total cholesterol concentration at fasting(3 months)
- Change in glucose concentration at fasting(3 months)