An interventional study of HE programme and Usual care in Cardiovascular Diseases, Healthy Lifestyle and Health Education, sponsored by The Hong Kong Polytechnic University. Status unknown. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Prevention
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 assess the feasibility of implementing an integrated exercise and cardiovascular health education programme (HE programme) on older adults at risk of ASCVD.
The study is a two-arm pilot randomized controlled trial. (1) The control group will receive a basic lifestyle modification talk 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, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, Week 6, and Week 12. Meanwhile, study feasibility will be primarily evaluated in terms of programme acceptability, intervention integrity, recruitment rate and retention rate throughout the process and at Week 12.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →The Hong Kong Polytechnic University is the lead sponsor of 659 studies on the registry; 250 are open to participants now.
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Exclusion Criteria:
Receive an integrated exercise and cardiovascular health education programme (HE programme)
Behavioral: HE programme
Receive usual care
Behavioral: Usual care
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. Governmental health education leaflets will be provided for reference.
Physical activity level (total score)
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, at Week 6, and at Week 12
Physical activity level (classification of physical activity level)
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, at Week 6, and at Week 12
Exercise self-efficacy
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, at Week 6, and at Week 12
ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate)
The ASCVD risk profiles will be assessed by physical evaluations carried out by blinded, trained outcome assessors.
Time frame: At baseline, at Week 6, and at Week 12
ASCVD risk profiles (2-minute walk test)
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 screening stage, at Week 6, and at Week 12
Acceptability of the program to participants
It will be measured by a self-developed questionnaire
Time frame: At Week 12
Acceptability of the program to outcome assessors
It will be measured by a self-developed questionnaire completed by outcome assessors
Time frame: After the outcome assessors have finished their duties
Acceptability of the program to lecture deliverers
It will be measured by a self-developed questionnaire completed by lecture deliverers
Time frame: After the lecture deliverers have finished their duties
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
Program safety evaluated by participants
It will be measured via a self-developed questionnaire completed by participants
Time frame: At Week 12
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
The percentage of participants remaining in the study
Time frame: At baseline, at Week 6 and at Week 12
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 6 and at Week 12
Attendance rate to data collection
* 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, at Week 6 and at Week 12
Questionnaire completion rate
The number of participants who complete the questionnaire divided by the number of distributed questionnaires
Time frame: At baseline, at Week 6 and at Week 12
Missing data
The percentage of missing data
Time frame: At baseline, at Week 6 and at Week 12
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
No study locations are listed for this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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The Hong Kong Polytechnic University