- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05986058
Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic
August 9, 2023 updated by: Soonhyung Kwon, University of Illinois at Urbana-Champaign
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- 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 Locations
-
-
-
Seoul, Korea, Republic of
- Mokdong Senior Welfare Center
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- aged 60 and over
- enrolled member at the participating senior center for at least three years
- fluent in Korean
Exclusion Criteria:
- younger than 60 years old
- less than three years enrollment at the senior center
- cannot read and speak Korean
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: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hybrid PA intervention
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical function
Time Frame: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
|
muscular function and cardiopulmonary endurance
|
Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
September 1, 2020
Primary Completion (Actual)
January 31, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
December 14, 2022
First Submitted That Met QC Criteria
August 9, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21916
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
It requires the data agreement from the director (Noh-Suk Park).
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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