Clinical trial NCT05434273: Effects of Integrated Cardiovascular Health Education Program on Older Adults at Risk of ASCVD
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Healthy Lifestyle
Health Education
Keywords: Older Adults
Physical Activity
Atherosclerotic Cardiovascular Disease
Lifestyle Modification
Health Education
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 190
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Physical activity level (total score) at Week 24
timeFrame: At Week 24
measure: Physical activity level (classification of physical activity level) at Week 24
timeFrame: At Week 24
Secondary outcomes:
measure: Exercise self-efficacy at baseline
timeFrame: At baseline
measure: Exercise self-efficacy at Week 12
timeFrame: At Week 12
measure: Exercise self-efficacy at Week 24
timeFrame: At Week 24
measure: Exercise self-efficacy at Week 36
timeFrame: At Week 36
measure: ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at baseline
timeFrame: At baseline
measure: ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 12
timeFrame: At Week 12
measure: ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 24
timeFrame: At Week 24
measure: ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 36
timeFrame: At Week 36
measure: 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
timeFrame: At baseline
measure: 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
timeFrame: At Week 24
measure: 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
timeFrame: At Week 36
measure: ASCVD risk profiles (2-minute walk test) at baseline
timeFrame: At baseline
measure: ASCVD risk profiles (2-minute walk test) at Week 12
timeFrame: At Week 12
measure: ASCVD risk profiles (2-minute walk test) at Week 24
timeFrame: At Week 24
measure: ASCVD risk profiles (2-minute walk test) at Week 36
timeFrame: At Week 36
measure: Adverse events throughout the program
timeFrame: Throughout the study period
measure: Eligibility rate
timeFrame: At baseline
measure: Recruitment rate
timeFrame: At baseline
measure: Retention rate at baseline
timeFrame: At baseline
measure: Retention rate at Week 12
timeFrame: At Week 12
measure: Retention rate at Week 24
timeFrame: At Week 24
measure: Retention rate at Week 36
timeFrame: At Week 36
measure: Lecture attendance rate
timeFrame: Immediately after education session
measure: Adherence to intervention
timeFrame: At Week 36
measure: Attendance rate to data collection at baseline
timeFrame: At baseline
measure: Attendance rate to data collection at Week 12
timeFrame: At Week 12
measure: Attendance rate to data collection at Week 24
timeFrame: At Week 24
measure: Attendance rate to data collection at Week 36
timeFrame: At Week 36
measure: Questionnaire completion rate at baseline
timeFrame: At baseline
measure: Questionnaire completion rate at Week 12
timeFrame: At Week 12
measure: Questionnaire completion rate at Week 24
timeFrame: At Week 24
measure: Questionnaire completion rate at Week 36
timeFrame: At Week 36
measure: Missing data at baseline
timeFrame: At baseline
measure: Missing data at Week 12
timeFrame: At Week 12
measure: Missing data at Week 24
timeFrame: At Week 24
measure: Missing data at Week 36
timeFrame: At Week 36
measure: Structured questionnaire
timeFrame: At baseline
measure: Physical activity level (total score) at baseline
timeFrame: At baseline
measure: Physical activity level (total score) at Week 12
timeFrame: At Week 12
measure: Physical activity level (total score) at Week 36
timeFrame: At Week 36
measure: Physical activity level (classification of physical activity level) at baseline
timeFrame: At baseline
measure: Physical activity level (classification of physical activity level) at Week 12
timeFrame: At Week 12
measure: Physical activity level (classification of physical activity level) at Week 36
timeFrame: At Week 36
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Ka Yan Ho
role: STUDY_DIRECTOR
References: