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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
190
Participants will receive a 12-week integrated exercise and cardiovascular health education programme (HE programme) which is constructed based on self-efficacy theory. A booster intervention in the form of SMS messaging will be given from Week 1 to Week 12.
Participants will receive usual care which primarily includes an education talk on basic health issues. A governmental health education leaflet and a lecture video will be provided for reference.
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Physical activity level (total score) 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.
Time frame: At Week 24
Physical activity level (classification of physical activity level) 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.
Time frame: At Week 24
Exercise self-efficacy 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.
Time frame: At baseline
Exercise self-efficacy 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.
Time frame: At Week 12
Exercise self-efficacy 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.
Time frame: At Week 24
Exercise self-efficacy at Week 36
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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.
Time frame: At Week 36
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at baseline
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
Time frame: At baseline
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 12
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
Time frame: At Week 12
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 24
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
Time frame: At Week 24
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 36
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
Time frame: 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 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.
Time frame: At baseline
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
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.
Time frame: 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 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.
Time frame: At Week 36
ASCVD risk profiles (2-minute walk test) 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.
Time frame: At baseline
ASCVD risk profiles (2-minute walk test) 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.
Time frame: At Week 12
ASCVD risk profiles (2-minute walk test) 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.
Time frame: At Week 24
ASCVD risk profiles (2-minute walk test) 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.
Time frame: At Week 36
Adverse events throughout the program
Unfavorable or unintended events regarding the programme reported by participants throughout the study period.
Time frame: Throughout the study period
Eligibility rate
The number of eligible potential participants divided by the number of screened people
Time frame: At baseline
Recruitment rate
The percentage of participants who consent to join the study and being recruited
Time frame: At baseline
Retention rate at baseline
The percentage of participants remaining in the study
Time frame: At baseline
Retention rate at Week 12
The percentage of participants remaining in the study
Time frame: At Week 12
Retention rate at Week 24
The percentage of participants remaining in the study
Time frame: At Week 24
Retention rate at Week 36
The percentage of participants remaining in the study
Time frame: At Week 36
Lecture attendance rate
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
Time frame: Immediately after education session
Adherence to intervention
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
Time frame: At Week 36
Attendance rate to data collection 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
Time frame: At baseline
Attendance rate to data collection 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
Time frame: At Week 12
Attendance rate to data collection 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
Time frame: At Week 24
Attendance rate to data collection 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
Time frame: At Week 36
Questionnaire completion rate at baseline
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Time frame: At baseline
Questionnaire completion rate at Week 12
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Time frame: At Week 12
Questionnaire completion rate at Week 24
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Time frame: At Week 24
Questionnaire completion rate at Week 36
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Time frame: At Week 36
Missing data at baseline
The percentage of missing data
Time frame: At baseline
Missing data at Week 12
The percentage of missing data
Time frame: At Week 12
Missing data at Week 24
The percentage of missing data
Time frame: At Week 24
Missing data at Week 36
The percentage of missing data
Time frame: At Week 36
Structured questionnaire
The questionnaire will primarily include patient demographics, medical history, lifestyle patterns, medication use and physical fitness evaluation data, etc.
Time frame: At baseline
Physical activity level (total score) 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.
Time frame: At baseline
Physical activity level (total score) 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.
Time frame: At Week 12
Physical activity level (total score) 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.
Time frame: At Week 36
Physical activity level (classification of physical activity level) 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.
Time frame: At baseline
Physical activity level (classification of physical activity level) 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.
Time frame: At Week 12
Physical activity level (classification of physical activity level) 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.
Time frame: At Week 36