Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 419487 for:    ALL
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05434273
Recruitment Status : Not yet recruiting
First Posted : June 27, 2022
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Dr Eva Ho, The Hong Kong Polytechnic University

Tracking Information
First Submitted Date  ICMJE June 11, 2022
First Posted Date  ICMJE June 27, 2022
Last Update Posted Date June 27, 2022
Estimated Study Start Date  ICMJE February 2023
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2022)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Eligibility rate [ Time Frame: At baseline ]
    The number of eligible potential participants divided by the number of screened people
  • Recruitment rate [ Time Frame: At baseline ]
    The percentage of participants who consent to join the study and being recruited
  • Retention rate at baseline [ Time Frame: At baseline ]
    The percentage of participants remaining in the study
  • Retention rate at Week 12 [ Time Frame: At Week 12 ]
    The percentage of participants remaining in the study
  • Retention rate at Week 24 [ Time Frame: At Week 24 ]
    The percentage of participants remaining in the study
  • Retention rate at Week 36 [ Time Frame: At Week 36 ]
    The percentage of participants remaining in the study
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Questionnaire completion rate at baseline [ Time Frame: At baseline ]
    The number of participants who complete the questionnaire divided by the number of distributed questionnaires
  • 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
  • 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
  • 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
  • Missing data at baseline [ Time Frame: At baseline ]
    The percentage of missing data
  • Missing data at Week 12 [ Time Frame: At Week 12 ]
    The percentage of missing data
  • Missing data at Week 24 [ Time Frame: At Week 24 ]
    The percentage of missing data
  • Missing data at Week 36 [ Time Frame: At Week 36 ]
    The percentage of missing data
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Integrated Cardiovascular Health Education Program on Older Adults at Risk of ASCVD
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cardiovascular Diseases
  • Healthy Lifestyle
  • Health Education
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Experimental Arm: Integrated Intervention
    Receive an integrated exercise and cardiovascular health education programme (HE programme)
    Intervention: Behavioral: HE programme
  • Sham Comparator: Control
    Receive usual care
    Intervention: Behavioral: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2022)
190
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2025
Estimated Primary Completion Date November 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ka Yan Ho 27666417 kyeva.ho@polyu.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05434273
Other Study ID Numbers  ICMJE ASCVD_OlderAdult_Full
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Eva Ho, The Hong Kong Polytechnic University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Hong Kong Polytechnic University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ka Yan Ho The Hong Kong Polytechnic University
PRS Account The Hong Kong Polytechnic University
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP