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临床试验/NCT07302568
NCT07302568已完成不适用

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

National Taipei University of Nursing and Health Sciences2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
Muscle Strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Strength Training plus Taiwanese Opera-based Activities (Behavioral)

Usual Activity

No Intervention

Control : Usual Activity(No Intervention)

结局指标

主要结局

Muscle Strength

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wu Gueyhau

Associate Professor

National Taipei University of Nursing and Health Sciences

研究点 (2)

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