Cardiovascular HealthNCT05986058
Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic
A study testing Golden Circle in people with Cardiovascular Health and Physical Function, run by University of Illinois at Urbana-Champaign at 1 site in South Korea.
Trial summary
This study tested preliminary efficacy of a hybrid (web-based and center-based) PA intervention combining use of a smartwatch and mobile application. The 12-week hybrid PA intervention included 120 older Korean adults and was concurrently implemented in-person at the local senior center and at-home through a web-based… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiovascular Health, Physical Function
- What is being tested?
- Golden Circle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60 and over
- enrolled member at the participating senior center for at least three years
- fluent in Korean
Who cannot join
- younger than 60 years old
- less than three years enrollment at the senior center
- cannot read and speak Korean
Trial locations and contacts
1 site in 1 country.
About this study
This study tested preliminary efficacy of a hybrid (web-based and center-based) PA intervention combining use of a smartwatch and mobile application. The 12-week hybrid PA intervention included 120 older Korean adults and was concurrently implemented in-person at the local senior center and at-home through a web-based modality. Overall, increases were evident in systolic/diastolic blood pressure, total cholesterol, and high-density-lipoprotein at posttest, with decreases seen for triglyceride levels. Participants showed improvements in muscular function and cardiopulmonary endurance.
- Conditions
- Cardiovascular Health, Physical Function
- Being tested
- Golden Circle
- Keywords
- Physical activity intervention, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Golden CircleBehavioural
The original Golden Circle project was deployed in response to the COVID-19 pandemic and the need to implement remote social services in South Korea. Golden Circle had the aim of building a case management model using a healthcare-oriented automation system based on wearable devices (smartwatches and mobile applications). Through innovative system expansions, the goals were to promote healthful CVH and physical function and cultivate self-care management skills in older Korean adults.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid PA intervention | Experimental | The PA intervention implemented 1-hour sessions for 12 weeks focusing on improving (1) body muscle, (2) body flexibility, (3) muscle endurance, and (4) body balance. The 12-week hybrid PA intervention was concurrently deployed in-person at a senior center and at-home through a web-based modality. Receives: Behavioral: Golden Circle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular health
systolic and diastolic blood pressure, total cholesterol, high-density lipoprotein, and triglycerides
Measured: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
Secondary outcomes (1)
Physical function
muscular function and cardiopulmonary endurance
Measured: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Sep 2020
- Primary completion31 Jan 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soonhyung Kwon, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986058
- Sponsor's protocol ID
- 21916
- Status last verified
- Aug 2023
- First submitted
- 14 Dec 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It requires the data agreement from the director (Noh-Suk Park).
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05986058
- Acronym / sponsor ID
- 21916
- Conditions
- Cardiovascular Health, Physical Function
- Keywords
- Physical activity intervention, Older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tested preliminary efficacy of a hybrid (web-based and center-based) PA intervention combining use of a smartwatch and mobile application. The 12-week hybrid PA intervention included 120 older Korean adults and was concurrently implemented in-person at the local senior center and at-home through a web-based modality. Overall, increases were evident in systolic/diastolic blood pressure, total cholesterol, and high-density-lipoprotein at posttest, with decreases seen for triglyceride levels. Participants showed improvements in muscular function and cardiopulmonary endurance.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid PA intervention | Experimental | Behavioral: Golden CircleThe PA intervention implemented 1-hour sessions for 12 weeks focusing on improving (1) body muscle, (2) body flexibility, (3) muscle endurance, and (4) body balance. The 12-week hybrid PA intervention was concurrently deployed in-person at a senior center and at-home through a web-based modality. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 60 and over
- enrolled member at the participating senior center for at least three years
- fluent in Korean
Key exclusion criteria (3 listed)
- younger than 60 years old
- less than three years enrollment at the senior center
- cannot read and speak Korean
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Golden CircleThe original Golden Circle project was deployed in response to the COVID-19 pandemic and the need to implement remote social services in South Korea. Golden Circle had the aim of building a case management model using a healthcare-oriented automation system based on wearable devices (smartwatches and mobile applications). Through innovative system expansions, the goals were to promote healthful CVH and physical function and cultivate self-care management skills in older Korean adults. | Behavioural | Hybrid PA intervention |
Primary outcome
Cardiovascular health
Time frame: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
systolic and diastolic blood pressure, total cholesterol, high-density lipoprotein, and triglycerides
1 secondary outcome
Physical function
Time frame: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided. It requires the data agreement from the director (Noh-Suk Park).
Related trials for Cardiovascular Health
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Active, not recruitingObservational study
Passive Limb Movement: A Tool to Assess Vascular Health and Guide Rehabilitation
Aging, Cardiovascular Disease
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Golden Circle in people with Cardiovascular Health and Physical Function, run by University of Illinois at Urbana-Champaign at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular health (time frame: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.