Effects of Integrated Cardiovascular Health Education Program on Older Adults at Risk of ASCVD
- Conditions
- Health EducationCardiovascular DiseasesHealthy Lifestyle
- Interventions
- Behavioral: Usual careBehavioral: HE programme
- Registration Number
- NCT05434273
- Lead Sponsor
- The Hong Kong Polytechnic University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 190
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Usual care Receive usual care Experimental Arm: Integrated Intervention HE programme Receive an integrated exercise and cardiovascular health education programme (HE programme)
- Primary Outcome Measures
Name Time Method Physical activity level (classification of physical activity level) at Week 24 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 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.
- Secondary Outcome Measures
Name Time Method Exercise self-efficacy at Week 36 At Week 36 Exercise self-efficacy will be measured via the Chinese version of Self-Efficacy for Exercise (SEE-C). The total score ranges from 0 to 90. The higher the score, the greater the exercise self-efficacy.
Exercise self-efficacy at Week 24 At Week 24 Exercise self-efficacy will be measured via the Chinese version of Self-Efficacy for Exercise (SEE-C). The total score ranges from 0 to 90. The higher the score, the greater the exercise self-efficacy.
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 36 At Week 36 The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
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 The ASCVD risk profiles will be assessed by obtaining finger-prick blood samples using an auto-analyser, carried out by blinded, trained outcome assessors. Fasting 8 hours before obtaining blood samples will be required.
ASCVD risk profiles (2-minute walk test) at Week 36 At Week 36 2-minute walk test will be adopted to examine aerobic capacity and self-paced walking capacity by measuring the walking distance covered at two minutes. It will be assessed by blinded, trained outcome assessors.
Retention rate at Week 24 At Week 24 The percentage of participants remaining in the study
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 The ASCVD risk profiles will be assessed by obtaining finger-prick blood samples using an auto-analyser, carried out by blinded, trained outcome assessors. Fasting 8 hours before obtaining blood samples will be required.
Lecture attendance rate Immediately after education session The number of participants in the control group who attend the education talk divided by the number of participants who are randomized into the control group The number of participants in the experimental group who attend the education session divided by the number of participants who are randomized into the experimental group The number of participants in the two groups who attend the education session divided by the number of randomized participants
Structured questionnaire At baseline The questionnaire will primarily include patient demographics, medical history, lifestyle patterns, medication use and physical fitness evaluation data, etc.
Physical activity level (classification of physical activity level) at Week 36 At Week 36 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.
Exercise self-efficacy at baseline At baseline Exercise self-efficacy will be measured via the Chinese version of Self-Efficacy for Exercise (SEE-C). The total score ranges from 0 to 90. The higher the score, the greater the exercise self-efficacy.
ASCVD risk profiles (2-minute walk test) at Week 12 At Week 12 2-minute walk test will be adopted to examine aerobic capacity and self-paced walking capacity by measuring the walking distance covered at two minutes. It will be assessed by blinded, trained outcome assessors.
Retention rate at Week 12 At Week 12 The percentage of participants remaining in the study
Retention rate at Week 36 At Week 36 The percentage of participants remaining in the study
Attendance rate to data collection at Week 24 At Week 24 The number of participants in the control group who attend the data collection divided by the number of participants who are randomized into the control group The number of participants in the experimental group who attend the data collection divided by the number of participants who are randomized into the experimental group The number of participants who attend the data collection divided by the number of randomized participants
Physical activity level (total score) at Week 12 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.
Exercise self-efficacy at Week 12 At Week 12 Exercise self-efficacy will be measured via the Chinese version of Self-Efficacy for Exercise (SEE-C). The total score ranges from 0 to 90. The higher the score, the greater the exercise self-efficacy.
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 24 At Week 24 The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
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 The ASCVD risk profiles will be assessed by obtaining finger-prick blood samples using an auto-analyser, carried out by blinded, trained outcome assessors. Fasting 8 hours before obtaining blood samples will be required.
Eligibility rate At baseline The number of eligible potential participants divided by the number of screened people
Attendance rate to data collection at Week 36 At Week 36 The number of participants in the control group who attend the data collection divided by the number of participants who are randomized into the control group The number of participants in the experimental group who attend the data collection divided by the number of participants who are randomized into the experimental group The number of participants who attend the data collection divided by the number of randomized participants
Questionnaire completion rate at baseline At baseline The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Questionnaire completion rate at Week 36 At Week 36 The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Missing data at baseline At baseline The percentage of missing data
Missing data at Week 12 At Week 12 The percentage of missing data
Missing data at Week 24 At Week 24 The percentage of missing data
Physical activity level (total score) at baseline At baseline 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.
Physical activity level (classification of physical activity level) at baseline At baseline 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.
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at baseline At baseline The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 12 At Week 12 The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
ASCVD risk profiles (2-minute walk test) at baseline At baseline 2-minute walk test will be adopted to examine aerobic capacity and self-paced walking capacity by measuring the walking distance covered at two minutes. It will be assessed by blinded, trained outcome assessors.
ASCVD risk profiles (2-minute walk test) at Week 24 At Week 24 2-minute walk test will be adopted to examine aerobic capacity and self-paced walking capacity by measuring the walking distance covered at two minutes. It will be assessed by blinded, trained outcome assessors.
Adverse events throughout the program Throughout the study period Unfavorable or unintended events regarding the programme reported by participants throughout the study period.
Recruitment rate At baseline The percentage of participants who consent to join the study and being recruited
Retention rate at baseline At baseline The percentage of participants remaining in the study
Physical activity level (total score) at Week 36 At Week 36 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.
Physical activity level (classification of physical activity level) at Week 12 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.
Adherence to intervention At Week 36 The number of participants in the experimental group who practice the tailor-made exercise learned during the intervention divided by the number of participants in the experimental group Experimental group's frequency in performing tailor-made exercise related to the recommended exercise dosage
Attendance rate to data collection at baseline At baseline The number of participants in the control group who attend the data collection divided by the number of participants who are randomized into the control group The number of participants in the experimental group who attend the data collection divided by the number of participants who are randomized into the experimental group The number of participants who attend the data collection divided by the number of randomized participants
Attendance rate to data collection at Week 12 At Week 12 The number of participants in the control group who attend the data collection divided by the number of participants who are randomized into the control group The number of participants in the experimental group who attend the data collection divided by the number of participants who are randomized into the experimental group The number of participants who attend the data collection divided by the number of randomized participants
Questionnaire completion rate at Week 12 At Week 12 The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Questionnaire completion rate at Week 24 At Week 24 The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Missing data at Week 36 At Week 36 The percentage of missing data
Trial Locations
- Locations (1)
The Hong Kong Polytechnic University
🇭🇰Hong Kong, Hong Kong