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

June 19, 2022 updated by: Dr Eva Ho, The Hong Kong Polytechnic University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
190

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Arm: Integrated Intervention
Receive an integrated exercise and cardiovascular health education programme (HE programme)
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.
Sham Comparator: Control
Receive usual care
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical activity level (total score) at Week 24
Time Frame: 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
Physical activity level (classification of physical activity level) at Week 24
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise self-efficacy at baseline
Time Frame: 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
Exercise self-efficacy at Week 12
Time Frame: 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
Exercise self-efficacy at Week 24
Time Frame: 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
Exercise self-efficacy at Week 36
Time Frame: 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
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at baseline
Time Frame: At baseline
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
At baseline
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 12
Time Frame: At Week 12
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
At Week 12
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 24
Time Frame: At Week 24
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
At Week 24
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at Week 36
Time Frame: At Week 36
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
ASCVD risk profiles (2-minute walk test) at baseline
Time Frame: 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
ASCVD risk profiles (2-minute walk test) at Week 12
Time Frame: 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
ASCVD risk profiles (2-minute walk test) at Week 24
Time Frame: 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
ASCVD risk profiles (2-minute walk test) at Week 36
Time Frame: 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
Adverse events throughout the program
Time Frame: Throughout the study period
Unfavorable or unintended events regarding the programme reported by participants throughout the study period.
Throughout the study period
Eligibility rate
Time Frame: At baseline
The number of eligible potential participants divided by the number of screened people
At baseline
Recruitment rate
Time Frame: At baseline
The percentage of participants who consent to join the study and being recruited
At baseline
Retention rate at baseline
Time Frame: At baseline
The percentage of participants remaining in the study
At baseline
Retention rate at Week 12
Time Frame: At Week 12
The percentage of participants remaining in the study
At Week 12
Retention rate at Week 24
Time Frame: At Week 24
The percentage of participants remaining in the study
At Week 24
Retention rate at Week 36
Time Frame: At Week 36
The percentage of participants remaining in the study
At Week 36
Lecture attendance rate
Time Frame: 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
Immediately after education session
Adherence to intervention
Time Frame: 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
At Week 36
Attendance rate to data collection at baseline
Time Frame: 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
Attendance rate to data collection at Week 12
Time Frame: 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
Attendance rate to data collection at Week 24
Time Frame: 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
Attendance rate to data collection at Week 36
Time Frame: 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
Questionnaire completion rate at baseline
Time Frame: At baseline
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
At baseline
Questionnaire completion rate at Week 12
Time Frame: At Week 12
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
At Week 12
Questionnaire completion rate at Week 24
Time Frame: At Week 24
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
At Week 24
Questionnaire completion rate at Week 36
Time Frame: At Week 36
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
At Week 36
Missing data at baseline
Time Frame: At baseline
The percentage of missing data
At baseline
Missing data at Week 12
Time Frame: At Week 12
The percentage of missing data
At Week 12
Missing data at Week 24
Time Frame: At Week 24
The percentage of missing data
At Week 24
Missing data at Week 36
Time Frame: At Week 36
The percentage of missing data
At Week 36
Structured questionnaire
Time Frame: At baseline
The questionnaire will primarily include patient demographics, medical history, lifestyle patterns, medication use and physical fitness evaluation data, etc.
At baseline
Physical activity level (total score) at baseline
Time Frame: 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
Physical activity level (total score) at Week 12
Time Frame: 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
Physical activity level (total score) at Week 36
Time Frame: 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
Physical activity level (classification of physical activity level) at baseline
Time Frame: 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
Physical activity level (classification of physical activity level) at Week 12
Time Frame: 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
Physical activity level (classification of physical activity level) at Week 36
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hong Kong Polytechnic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ka Yan Ho, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ASCVD_OlderAdult_Full

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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