The Effects of an Integrated Exercise and Cardiovascular Health Education Programme on Community-dwelling Older Adults at Risk of Atherosclerotic Cardiovascular Diseases: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Physical activity level (classification of physical activity level) at Week 24
研究概览
简要总结
Despite older adults being exposed to an increased risk of atherosclerotic cardiovascular disease (ASCVD), they are generally underrepresented in cardiovascular prevention programmes. The aim of this study is to examine the effects of an integrated exercise and cardiovascular health education programme (HE programme) on community-dwelling older adults at risk of ASCVD.
详细描述
The study is a two-arm randomized controlled trial. (1) The control group will mainly receive a basic lifestyle modification talk, a lecture video and governmental education leaflets. (2) The experimental group will receive an integrated exercise and health education programme (HE programme) based on self-efficacy theory. Physical activity level, exercise self-efficacy and ASCVD risk profile including blood pressure, cardiac endurance, fasting blood glucose, fasting blood lipids, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, Week 12, Week 24 and Week 36.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese adults ≧60 years old
- •Having at least one ASCVD risk factor
- •Pass the cardiovascular fitness evaluation
- •Able to write and read Chinese, and communicate in Cantonese;
- •Possess a mobile phone and able to make use of the phone in reading short messages
排除标准
- •Visually impaired, hearing impaired, or suffer from cognitive, psychiatric, or muscular disorder
- •Having a history of attending similar cardiovascular prevention program
- •Having a previous history of coronary heart disease or stroke
结局指标
主要结局
Physical activity level (classification of physical activity level) at Week 24
时间窗: At Week 24
The physical activity level will be measured by the Chinese version of International Physical Activity Questionnaire-short form (IPAQ-C-short form). Participants are classified into "inactive", "minimally active" or "health enhancing physical activity (HEPA) active" based on their physical activity levels.
Physical activity level (total score) at Week 24
时间窗: At Week 24
The physical activity level will be measured by the Chinese Version of Physical Activity Scale for the Elderly (PASE-C). The total score (from zero to 400 or above) is quantified based on frequency values and weights for these activities. The higher the score, the higher the level of physical activity.
次要结局
- Exercise self-efficacy at Week 36(At Week 36)
- ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 36(At Week 36)
- ASCVD risk profiles (Fasting blood glucose and fasting blood lipids including low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides) at Week 36(At Week 36)
- ASCVD risk profiles (2-minute walk test) at Week 36(At Week 36)
- Retention rate at Week 24(At Week 24)
- ASCVD risk profiles (Fasting blood glucose and fasting blood lipids including low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides) at Week 24(At Week 24)
- Lecture attendance rate(Immediately after education session)
- Structured questionnaire(At baseline)
- Physical activity level (classification of physical activity level) at Week 36(At Week 36)
- Exercise self-efficacy at baseline(At baseline)
- Exercise self-efficacy at Week 24(At Week 24)
- ASCVD risk profiles (2-minute walk test) at Week 12(At Week 12)
- Retention rate at Week 12(At Week 12)
- Retention rate at Week 36(At Week 36)
- Attendance rate to data collection at Week 24(At Week 24)
- Physical activity level (total score) at Week 12(At Week 12)
- Exercise self-efficacy at Week 12(At Week 12)
- ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 24(At Week 24)
- ASCVD risk profiles (Fasting blood glucose and fasting blood lipids including low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides) at baseline(At baseline)
- Eligibility rate(At baseline)
- Attendance rate to data collection at Week 36(At Week 36)
- Questionnaire completion rate at baseline(At baseline)
- Questionnaire completion rate at Week 36(At Week 36)
- Missing data at baseline(At baseline)
- Missing data at Week 12(At Week 12)
- Missing data at Week 24(At Week 24)
- Physical activity level (total score) at baseline(At baseline)
- Physical activity level (classification of physical activity level) at baseline(At baseline)
- ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at baseline(At baseline)
- ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 12(At Week 12)
- ASCVD risk profiles (2-minute walk test) at baseline(At baseline)
- ASCVD risk profiles (2-minute walk test) at Week 24(At Week 24)
- Adverse events throughout the program(Throughout the study period)
- Recruitment rate(At baseline)
- Retention rate at baseline(At baseline)
- Physical activity level (total score) at Week 36(At Week 36)
- Physical activity level (classification of physical activity level) at Week 12(At Week 12)
- Adherence to intervention(At Week 36)
- Attendance rate to data collection at baseline(At baseline)
- Attendance rate to data collection at Week 12(At Week 12)
- Questionnaire completion rate at Week 12(At Week 12)
- Questionnaire completion rate at Week 24(At Week 24)
- Missing data at Week 36(At Week 36)
研究者
Dr Eva Ho
Assistant Professor
The Hong Kong Polytechnic University