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临床试验/NCT07835503
NCT07835503已完成不适用

Feasibility, Safety, Acceptability, and Effects of an Assisted Lifestyle-integrated Functional Exercise Program on Balance and Muscle Strength in Older Adults Living in Residential Care Facilities: a Feasibility Cluster Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2025年5月1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
49
试验地点
1
主要终点
Retention rate

研究概览

简要总结

More than half of older adults living in care homes experience a fall each year, which can cause serious injuries, hospital visits, and a loss of independence. While balance and muscle-strengthening exercises help prevent falls, traditional exercise programs are often difficult for care home residents to maintain because they require set schedules and unfamiliar movements, especially for those experiencing cognitive problems.

To address this challenge, our 12-week study evaluated the Assisted Lifestyle-integrated Functional Exercise (ALIFE) program across six residential care homes. Rather than holding separate workout sessions, ALIFE weaves personalized balance and strengthening activities directly into daily routines-such as rising from a chair or practicing steady standing while grooming. Visiting physiotherapists tailored the movements to each resident's needs, while trained care home staff offered gentle reminders and encouragement throughout the program. The investigators compared ALIFE to a traditional structured Otago exercise program (OTAGO) to determine if this approach is feasible, safe, and enjoyable for residents.

The investigators expect this lifestyle-based exercise program to be safe, enjoyable, and more effective than the traditional exercise program at helping residents preserve their balance and muscle strength. If successful, it will provide care homes with a practical, low-cost way to turn everyday habits into health-promoting activities without needing expensive equipment. Ultimately, these findings could guide future clinical practice and larger studies aimed at helping older adults stay mobile, confident, and independent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •Are at least 60 years old,
  • •Are permanently residing in care facilities,
  • •Are able to walk 10 meters with or without a walking aid independently,
  • •And their main caregiver (e.g., health and social care professionals working in the residential care facilities) can provide written consent.

排除标准

  • •Have a diagnosis of a terminal illness,
  • •Have participated in a structured balance or muscle strengthening program in the past 6 months,
  • •Are unsafe to participate in an exercise program due to any severe or unstable medical illness (e.g., advanced Parkinson's disease, acute exacerbation of knee osteoarthritis, and unstable angina), and
  • •Are unable to communicate due to severe visual or hearing impairment,
  • •Have a score below 10 in the Hong Kong version of the Montreal Cognitive Assessment, indicating that they have moderate to severe cognitive impairment.

研究组 & 干预措施

ALIFE

Experimental

干预措施: ALIFE exercise program (Behavioral)

OTAGO

Active Comparator

干预措施: OTAGO exercise program (Behavioral)

结局指标

主要结局

Retention rate

时间窗: 12 weeks

Proportion (%) of enrolled participants who completed the post-intervention assessment at 12 weeks.

Adverse event counts

时间窗: 12 weeks

Number of adverse events reported by participants and interventionists throughout the 12 weeks

Physical Activity Enjoyment Scale (PACES)

时间窗: 6 weeks and 12 weeks

Physical activity enjoyment scale (PACES) scores at 6 weeks and 12 weeks. The PACES is an 8-item instrument scored on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree), yielding a total score between 8 and 56. A higher score denotes greater exercise enjoyment.

次要结局

  • Balance(Baseline, 6 weeks, and 12 weeks)
  • Mobility(Baseline, 6 weeks, and 12 weeks)
  • Lower limb muscle strength(Baseline, 6 weeks, and 12 weeks)
  • Global cognition(Baseline, 6 weeks, and 12 weeks)
  • Attention(Baseline, 6 weeks, and 12 weeks)
  • Working memory(Baseline, 6 weeks, and 12 weeks)
  • Fear of falling(Baseline, 6 weeks, and 12 weeks)
  • Depressive symptoms(Baseline, 6 weeks, and 12 weeks)

研究者

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

Dr. Wayne Chan

Assistant Professor

The Hong Kong Polytechnic University

研究点 (1)

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