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Clinical Trials/NCT07302568
NCT07302568
Completed
Not Applicable

The Effects of Exercise and Gezaixi (Taiwanese Opera) Interventions on Community-Dwelling Older Adults

National Taipei University of Nursing and Health Sciences2 sites in 1 country120 target enrollmentStarted: December 20, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
Muscle Strength

Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
65 Years to 90 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age ≥65 years.
  • Community-dwelling older adults residing in Taipei.
  • Able to ambulate independently (with or without assistive device).
  • Able to communicate and provide informed consent.

Exclusion Criteria

  • Unstable cardiopulmonary disease or uncontrolled hypertension.
  • Severe cognitive impairment affecting participation.
  • Recent major surgery or fracture within the past 3 months.
  • Any contraindication to moderate-intensity exercise as assessed by the study team.

Arms & Interventions

Exercise with Taiwanese Opera Elements

Experimental

Weekly 2-hour group sessions for 12 consecutive weeks; 60 minutes progressive strength training plus 60 minutes Taiwanese opera-based activities.

Intervention: Strength Training plus Taiwanese Opera-based Activities (Behavioral)

Usual Activity

No Intervention

Control : Usual Activity(No Intervention)

Outcomes

Primary Outcomes

Muscle Strength

Time Frame: From enrollment to the end of intervention at 12 week

Change in muscle strength from baseline to week 12, measured using standardized tests (e.g., handgrip strength with a dynamometer in kilograms, or 30-second chair stand repetitions). Higher values indicate better strength.

Calf Circumference

Time Frame: rom enrollment to the end of treatment at 12 weeks

Change in calf circumference (centimeters) measured at the widest point of the non-dominant calf using a non-stretchable tape. Larger circumference generally indicates better muscle mass.

Calf Circumference

Time Frame: rom enrollment to the end of treatment at 12 weeks

Change in calf circumference (centimeters) measured at the widest point of the non-dominant calf using a non-stretchable tape. Larger circumference generally indicates better muscle mass.

Study of Osteoporotic Fractures (SOF) frailty score

Time Frame: From enrollment to the end of treatment at 12 week

Change in Study of Osteoporotic Fractures (SOF) frailty score (range 0-3; higher scores indicate greater frailty)

Muscle Strength

Time Frame: From enrollment to the end of intervention at 12 week

Change in muscle strength from baseline to week 12, measured using standardized tests (e.g., handgrip strength with a dynamometer in kilograms, or 30-second chair stand repetitions). Higher values indicate better strength.

Secondary Outcomes

  • SARC-F(From enrollment to the end of treatment at 12 weeks)
  • Brief Symptom Rating Scale 5-item (BSRS-5)(From enrollment to the end of treatment at 12 weeks)
  • SARC-F(From enrollment to the end of treatment at 12 weeks)
  • Geriatric Depression Scale score 5-item(GGDS-5)(From enrollment to the end of treatment at 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wu Gueyhau

Associate Professor

National Taipei University of Nursing and Health Sciences

Study Sites (2)

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