NCT07302568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

December 11, 2025

Last Update Submit

April 16, 2026

Conditions

Keywords

ExerciseGezaixi (Taiwanese Opera)Resistance ExerciseStrength TrainingCommunity-Dwelling Older Adults

Outcome Measures

Primary Outcomes (3)

  • Muscle Strength

    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.

    From enrollment to the end of intervention at 12 week

  • Calf Circumference

    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.

    rom enrollment to the end of treatment at 12 weeks

  • Study of Osteoporotic Fractures (SOF) frailty score

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

    From enrollment to the end of treatment at 12 week

Secondary Outcomes (3)

  • Brief Symptom Rating Scale 5-item (BSRS-5)

    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

  • SARC-F

    From enrollment to the end of treatment at 12 weeks

Study Arms (2)

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.

Behavioral: Strength Training plus Taiwanese Opera-based Activities

Usual Activity

NO INTERVENTION

Control : Usual Activity(No Intervention)

Interventions

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:

Also known as: Opera-integrated Exercise Program for Older Adults
Exercise with Taiwanese Opera Elements

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taipei University of Nursing and Health Sciences

Taipei, Taitau District, 11219, Taiwan

Location

MeSH Terms

Conditions

FrailtyMotor Activity

Interventions

Resistance TrainingAging

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaGrowth and DevelopmentPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2025

First Posted

December 24, 2025

Study Start

December 20, 2025

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations