- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07302568
Exercise and Gezaixi Interventions on Community-Dwelling Older Adults
April 16, 2026 updated by: Wu Gueyhau, National Taipei University of Nursing and Health Sciences
The Effects of Exercise and Gezaixi (Taiwanese Opera) 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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Taitau District
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Taipei, Taitau District, Taiwan, 11219
- National Taipei University of Nursing and Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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-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.
Other Names:
|
|
No Intervention: Usual Activity
Control : Usual Activity(No Intervention)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From enrollment to the end of intervention at 12 week
|
|
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.
|
rom enrollment to the end of treatment at 12 weeks
|
|
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)
|
From enrollment to the end of treatment at 12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
From enrollment to the end of treatment at 12 weeks
|
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
|
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.
|
From enrollment to the end of treatment at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2025
Primary Completion (Actual)
March 20, 2026
Study Completion (Actual)
March 20, 2026
Study Registration Dates
First Submitted
December 11, 2025
First Submitted That Met QC Criteria
December 11, 2025
First Posted (Actual)
December 24, 2025
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 16, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Behavior
- Frailty
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Physiological Phenomena
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Growth and Development
- Resistance Training
- Aging
Other Study ID Numbers
- 202503em021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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