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临床试验/NCT05476471
NCT05476471已完成不适用

The Short Effectiveness of Self-Management Skills and Health Promotion Programs on the Health Status of the Pre-frail Individuals in the Communities

Shu-Hung Chang1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
169
试验地点
1
主要终点
Frailty

研究概览

简要总结

This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.

详细描述

This pilot study aimed to examine the efficacy of a home-based multicomponent exercise training program in older community- dwellers during to the Coronavirus Disease 2019.

Design: A two-arm parallel cluster randomized controlled trial. Older adults ≥60 years old were recruited from eight community units in northern Taiwan. One-hundred and sixty-seven eligible subjects consented to participate in the study. Community units were randomly assigned to either an intervention arm (n=82) or a control arm (n=87). The intervention consisted of one 60-minutes group exercise session once a week in first 8 weeks, and self-management in next 8 weeks. The control arm received an education leaflet. Assessments were performed at baseline and 16 weeks for physical activity, physical performance, and pre-frailty rate. Analysis of covariance or chi-square test adjusted for pretest evaluated the differences between the two study arms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • older adult with age ≥ 60 years
  • community-dwelling
  • no hearing and visual acuity difficulties

排除标准

  • Unconscious
  • Cognitive impairment or dementia

结局指标

主要结局

Frailty

时间窗: 4 month follow up

Frailty measurement used study of osteoporotic fracture index (SOF)

Physical activity

时间窗: 4 month follow up

International Physical Activity Questionnaire (IPAQ)

short physical performance battery

时间窗: 4 month follow up

sit-to-stand, standing balance, and gait-speed

次要结局

  • physical agility and dynamic balance ability(4 month follow up)
  • upper limb muscle strength(4 month follow up)
  • static balance ability(4 month follow up)

研究者

发起方
Shu-Hung Chang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shu-Hung Chang

Professor

Chang Gung University of Science and Technology

研究点 (1)

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