Exercise and Gezaixi Interventions on Community-Dwelling Older Adults

NCT ID: NCT07302568

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2026-12-20

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.

Conditions

Frailty; Functional Decline; Community-Dwelling Older Adults

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise with Taiwanese Opera Elements

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

Group Type: EXPERIMENTAL

Strength Training plus Taiwanese Opera-based Activities

Intervention Type: 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:

Usual Activity

Control : Usual Activity（No Intervention）

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Strength Training plus Taiwanese Opera-based Activities

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:

Intervention Type: BEHAVIORAL

Other Intervention Names

Opera-integrated Exercise Program for Older Adults

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Wu Gueyhau

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Taipei University of Nursing and Health Sciences

Taipei, Taitau District, Taiwan

Countries

Taiwan

Other Identifiers

202503em021

Identifier Type: -

Identifier Source: org_study_id