Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic

• ClinicalTrials.gov Identifier: NCT05986058
• Recruitment Status: Completed
• First Posted: August 14, 2023
• Last Update Posted: August 14, 2023
• Sponsor: University of Illinois at Urbana-Champaign
• Information provided by (Responsible Party): Soonhyung Kwon, University of Illinois at Urbana-Champaign

Tracking Information

• First Submitted Date: December 14, 2022
• First Posted Date: August 14, 2023
• Last Update Posted Date: August 14, 2023
• Actual Study Start Date: September 1, 2020
• Actual Primary Completion Date: January 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 9, 2023)

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 9, 2023)

Physical function [ Time Frame: Pre (baseline) and posttest (through study completion, 12 weeks later from the baseline) ]

muscular function and cardiopulmonary endurance

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic
• Official Title: Preliminary Efficacy of a Technology-based Physical Activity Intervention for Older Korean Adults During the COVID-19 Pandemic
• Brief 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 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research

Condition

• Cardiovascular Health
• Physical Function

Intervention

Behavioral: Golden Circle

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 Arms

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.

Intervention: Behavioral: Golden Circle

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 9, 2023): 120
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 30, 2021
• Actual Primary Completion Date: January 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT05986058
• Other Study ID Numbers: 21916
• Has Data Monitoring Committee: Not Provided

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

• Plan to Share IPD: Undecided
• Plan Description: It requires the data agreement from the director (Noh-Suk Park).

• Current Responsible Party: Soonhyung Kwon, University of Illinois at Urbana-Champaign
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Illinois at Urbana-Champaign
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Illinois at Urbana-Champaign
• Verification Date: August 2023