The Effects of a Cardiovascular Health Education Program on Community-dwelling Older Adults at Risk of Atherosclerotic Cardiovascular Diseases: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Physical activity level (classification of physical activity level)
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 assess the feasibility of implementing an integrated exercise and cardiovascular health education programme (HE programme) on older adults at risk of ASCVD.
详细描述
The study is a two-arm pilot randomized controlled trial. (1) The control group will receive a basic lifestyle modification talk 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, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, Week 6, and Week 12. Meanwhile, study feasibility will be primarily evaluated in terms of programme acceptability, intervention integrity, recruitment rate and retention rate throughout the process and at Week 12.
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 SMS
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)
时间窗: At baseline, at Week 6, and at Week 12
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)
时间窗: At baseline, at Week 6, and at Week 12
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
- Acceptability of the program to participants(At Week 12)
- Acceptability of the program to outcome assessors(After the outcome assessors have finished their duties)
- Acceptability of the program to lecture deliverers(After the lecture deliverers have finished their duties)
- Exercise self-efficacy(At baseline, at Week 6, and at Week 12)
- ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate)(At baseline, at Week 6, and at Week 12)
- ASCVD risk profiles (2-minute walk test)(At screening stage, at Week 6, and at Week 12)
- Adverse events throughout the program(Throughout the study period)
- Eligibility rate(At baseline)
- Questionnaire completion rate(At baseline, at Week 6 and at Week 12)
- Recruitment rate(At baseline)
- Program safety evaluated by participants(At Week 12)
- Retention rate(At baseline, at Week 6 and at Week 12)
- Adherence to intervention(At Week 6 and at Week 12)
- Missing data(At baseline, at Week 6 and at Week 12)
- Lecture attendance rate(Immediately after education session)
- Attendance rate to data collection(At baseline, at Week 6 and at Week 12)
- Structured questionnaire(At baseline)
研究者
Dr Eva Ho
Assistant Professor
The Hong Kong Polytechnic University