Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-27 @ 2:04 AM
Study NCT ID:
NCT07302568
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Gezaixi Interventions on Community-Dwelling Older Adults
Sponsor:
National Taipei University of Nursing and Health Sciences
Organization:
Study Overview
Official Title:
The Effects of Exercise and Gezaixi (Taiwanese Opera) Interventions on Community-Dwelling Older Adults
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This interventional study evaluates a 12-week, once-weekly group exercise program combining 60 minutes of progressive strength training and 60 minutes of Taiwanese opera-based activities for community-dwelling adults aged ≥65 in Taipei. The primary aim is to delay frailty and functional decline by improving physical fitness and independence. Primary outcomes are muscle strength, calf circumference, and SOF frailty score; secondary outcomes are BSRS-5, GGDS-5, and SARC-F. The study uses a non-randomized, parallel two-arm design (exercise vs. usual activity), open-label, with assessments at baseline and week 12.
Detailed Description:
Participants attend weekly 120-minute sessions for 12 consecutive weeks at community centers. Strength training targets major muscle groups using body weight, elastic bands, or light dumbbells at moderate intensity (Borg RPE 11-13) with progressive overload. The Taiwanese opera-based segment integrates singing, reciting, acting, and martial arts elements to promote balance, coordination, posture, and endurance. Sessions include warm-up and cool-down. Certified C-level instructors lead classes; adherence and adverse events are monitored each session. Statistical analysis will compare pre-post changes within groups (paired t-tests) and between-group differences in change scores (independent t-tests or ANCOVA adjusting for baseline values). Missing data will be handled primarily using complete case analysis, with sensitivity analyses using linear mixed-effects models under a MAR assumption or multiple imputation as appropriate.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: