NCT05434273

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

June 11, 2022

Last Update Submit

June 19, 2022

Conditions

Keywords

Older AdultsPhysical ActivityAtherosclerotic Cardiovascular DiseaseLifestyle ModificationHealth Education

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (43)

  • Exercise self-efficacy at baseline

    At baseline

  • Exercise self-efficacy at Week 12

    At Week 12

  • Exercise self-efficacy at Week 24

    At Week 24

  • Exercise self-efficacy at Week 36

    At Week 36

  • ASCVD risk profiles (Blood pressure, weight, height, BMI & waist circumference, heart rate) at baseline

    At baseline

  • +38 more secondary outcomes

Study Arms (2)

Experimental Arm: Integrated Intervention

EXPERIMENTAL

Receive an integrated exercise and cardiovascular health education programme (HE programme)

Behavioral: HE programme

Control

SHAM COMPARATOR

Receive usual care

Behavioral: Usual care

Interventions

HE programmeBEHAVIORAL

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.

Experimental Arm: Integrated Intervention
Usual careBEHAVIORAL

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.

Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lo FMW, Wong EML, Ho KY. The effects of an integrated exercise and cardiovascular health education programme on community-dwelling older adults at risk of atherosclerotic cardiovascular diseases: A study protocol for a randomised controlled trial. PLoS One. 2023 May 24;18(5):e0286181. doi: 10.1371/journal.pone.0286181. eCollection 2023.

MeSH Terms

Conditions

Cardiovascular DiseasesHealth EducationMotor ActivityAtherosclerosis

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ka Yan Ho

    The Hong Kong Polytechnic University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 11, 2022

First Posted

June 27, 2022

Study Start

February 1, 2023

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

June 27, 2022

Record last verified: 2022-06

Locations