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NCT Number: NCT07302568

Exercise and Gezaixi Interventions on Community-Dwelling Older Adults

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.

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Key information

Conditions

Frailty Behavior Community-dwelling Older Adults Functional Decline Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taipei University of Nursing and Health Sciences

Taipei, Taitau District, 11219, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Strength Training plus Taiwanese Opera-based Activities

Behavioral

Group-based exercise delivered at community centers for community-dwelling adults aged ≥65 years. Frequency: once per week. Session length: 120 minutes per session (60 minutes progressive strength training + 60 minutes Taiwanese opera-based activities integrating singing, reciting, acting, and martial arts). Total duration: 12 consecutive weeks.

  • Content and progression: Strength training targets major muscle groups (e.g., sit-to-stand, rowing/pulling with elastic bands, hip abduction, calf raises) using body weight, elastic bands, or light dumbbells; intensity targeted at moderate level (Borg RPE 11-13) and progressed by resistance/repetitions as tolerated. The opera-based segment includes rhythmic movement, balance drills, upper-/lower-limb coordination, posture and breathing, and simple choreographed sequences adapted from Taiwanese opera elements. Each session includes ~10 minutes warm-up and ~10 minutes cool-down with flexibility and breathing exercises. Approximate group size:

Other names: Opera-integrated Exercise Program for Older Adults

Primary outcomes

  1. 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.

  2. 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.

  3. 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)

Secondary outcomes

  1. Brief Symptom Rating Scale 5-item (BSRS-5)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in the total score on the 5-item Brief Symptom Rating Scale (BSRS-5); higher scores indicate greater psychological distress. Scores range from 0 to 20.

  2. Geriatric Depression Scale score 5-item(GGDS-5)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Change in the 5-item Geriatric Depression Scale (GDS-5) score; higher scores indicate more depressive symptoms. Scores range from 0 to 5.

  3. SARC-F

    Time frame: From enrollment to the end of treatment at 12 weeks

    Description: Change in SARC-F questionnaire score for sarcopenia risk (range 0-10; higher scores indicate higher risk).

Sponsors and collaborators

Lead sponsor

National Taipei University of Nursing and Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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