Effects of Integrated Cardiovascular Health Education Program on Older Adults at Risk of ASCVD

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05434273
• Other study ID #: ASCVD_OlderAdult_Full
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: November 2025

Study information

• Verified date: June 2022
• Source: The Hong Kong Polytechnic University
• Contact: Ka Yan Ho
• Phone: 27666417
• Email: kyeva.ho[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 190
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Health Education
• Healthy Lifestyle

Intervention

Behavioral:
• HE programme
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.
• Usual care
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.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At Week 24
Primary	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.	At Week 24
Secondary	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.	At baseline
Secondary	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.	At Week 12
Secondary	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.	At Week 24
Secondary	Exercise self-efficacy 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.	At Week 36
Secondary	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.	At baseline
Secondary	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.	At Week 12
Secondary	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.	At Week 24
Secondary	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.	At Week 36
Secondary	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.	At baseline
Secondary	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.	At Week 24
Secondary	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.	At Week 36
Secondary	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.	At baseline
Secondary	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.	At Week 12
Secondary	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.	At Week 24
Secondary	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.	At Week 36
Secondary	Adverse events throughout the program	Unfavorable or unintended events regarding the programme reported by participants throughout the study period.	Throughout the study period
Secondary	Eligibility rate	The number of eligible potential participants divided by the number of screened people	At baseline
Secondary	Recruitment rate	The percentage of participants who consent to join the study and being recruited	At baseline
Secondary	Retention rate at baseline	The percentage of participants remaining in the study	At baseline
Secondary	Retention rate at Week 12	The percentage of participants remaining in the study	At Week 12
Secondary	Retention rate at Week 24	The percentage of participants remaining in the study	At Week 24
Secondary	Retention rate at Week 36	The percentage of participants remaining in the study	At Week 36
Secondary	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	Immediately after education session
Secondary	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	At Week 36
Secondary	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	At baseline
Secondary	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	At Week 12
Secondary	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	At Week 24
Secondary	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	At Week 36
Secondary	Questionnaire completion rate at baseline	The number of participants who complete the questionnaire divided by the number of distributed questionnaires	At baseline
Secondary	Questionnaire completion rate at Week 12	The number of participants who complete the questionnaire divided by the number of distributed questionnaires	At Week 12
Secondary	Questionnaire completion rate at Week 24	The number of participants who complete the questionnaire divided by the number of distributed questionnaires	At Week 24
Secondary	Questionnaire completion rate at Week 36	The number of participants who complete the questionnaire divided by the number of distributed questionnaires	At Week 36
Secondary	Missing data at baseline	The percentage of missing data	At baseline
Secondary	Missing data at Week 12	The percentage of missing data	At Week 12
Secondary	Missing data at Week 24	The percentage of missing data	At Week 24
Secondary	Missing data at Week 36	The percentage of missing data	At Week 36
Secondary	Structured questionnaire	The questionnaire will primarily include patient demographics, medical history, lifestyle patterns, medication use and physical fitness evaluation data, etc.	At baseline
Secondary	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.	At baseline
Secondary	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.	At Week 12
Secondary	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.	At Week 36
Secondary	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.	At baseline
Secondary	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.	At Week 12
Secondary	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.	At Week 36