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临床试验/NCT06672640
NCT06672640已完成不适用

Effects of Remote Exercise on Physical Function in Pre-Frail Older Adults: A Randomized Controlled Trial

Kyungdong University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年6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
90
试验地点
2
主要终点
Balance ability

研究概览

简要总结

This study aims to compare the effects of remote versus in-person exercise interventions on physical function, balance, gait stability, and fall efficacy in pre-frail older adults aged 65 years and above. Participants are randomly assigned to either a remote exercise group, an in-person exercise group, or a control group. The exercise intervention includes balance, strength, and gait training conducted twice weekly for eight weeks. The control group receives educational materials on physical activity. The primary outcome measures include assessments of balance, lower limb strength, gait ability, and fall efficacy. This study seeks to determine if remote exercise is as effective as in-person exercise in enhancing physical function in pre-frail older adults, potentially providing a feasible alternative to traditional in-person programs and addressing barriers such as limited mobility and access to exercise facilities.

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 (Outcomes Assessor)

盲法说明

The evaluators were blinded to the intervention details of the participants.

入排标准

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

入选标准

  • Aged 65 years or older
  • Classified as pre-frail based on Fried's frailty criteria (meeting at least two out of five specified indicators)
  • Experienced a fall in the preceding six months or have impaired gait and balance (TUG ≥ 13.5 seconds, BBS ≤ 45)
  • Mini-Mental State Examination (MMSE) score of 24 or higher
  • Demonstrate the physical capacity to engage in the remote exercise (e.g., ability to stand from a seated position and walk short distances)

排除标准

  • Neurological or musculoskeletal conditions that impede physical activity
  • Recent history of severe cardiovascular disease (within the past three months)
  • Inability to commit to continuous participation throughout the study period
  • Any other medical condition that might interfere with the intervention or pose a risk to the participant

结局指标

主要结局

Balance ability

时间窗: Baseline and post-intervention at 8 weeks

Balance performance will be assessed using the Timed Up and Go (TUG) test and Berg Balance Scale (BBS). The TUG measures the time taken for a participant to stand up from a chair, walk three meters, turn around, walk back, and sit down. The BBS is a comprehensive assessment of balance ability during various tasks.

Lower Limb Strength

时间窗: Baseline and post-intervention at 8 weeks

Lower limb strength will be evaluated using the Five Times Sit-to-Stand Test (FTSTS) and the 30-Second Chair Stand Test (30SCS). The FTSTS measures the time it takes for participants to rise from a chair five times, and the 30SCS measures the number of times participants can rise from a chair in 30 seconds.

Gait Ability

时间窗: Baseline and post-intervention at 8 weeks

Gait ability will be assessed using the Dynamic Gait Index (DGI) and the 10-Meter Walk Test (10MWT). The DGI assesses participants' ability to modify balance while walking in response to external demands, and the 10MWT measures the time taken to walk 10 meters at a comfortable speed.

Fall Efficacy

时间窗: Baseline and post-intervention at 8 weeks

Fall efficacy will be measured using the Modified Falls Efficacy Scale (MFES). This scale evaluates participants' confidence in performing daily activities without falling, providing an indication of fall-related self-efficacy.

次要结局

未报告次要终点

研究者

发起方
Kyungdong University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyeongjin Lee

professor

Kyungdong University

研究点 (2)

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