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临床试验/NCT06814678
NCT06814678尚未招募不适用

Effectiveness of Interactive Exergaming Combined with the Otago Exercise Program on Mobility in Older Individuals Living in Communities: a Cluster-Randomized Controlled Study

National Taiwan University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Mobility Performance

研究概览

简要总结

This clinical trial aims to evaluate the effectiveness of interactive exergaming combined with Otago Exercise Program on mobility among community-dwelling older adults aged 65 and above. The main research questions are:

Does this combined exercise intervention improve elderly mobility? Does this program enhance muscle strength and psychological well-being?

Researchers will compare two groups: one group will do the combined exercise program for 12 weeks, while the other group will continue their usual activities.

Participants will:

  • Have their health checked three times: at the start, after 12 weeks, and 3 months later
  • If in the exercise group, attend exercise sessions twice a week for 12 weeks
  • Complete tests about their physical abilities and how they feel emotionally

Who can take part:

  • Adults age 65 or older
  • People who need more than 12 seconds to stand up and sit down 5 times
  • People who can stand for at least 30 seconds with support

People cannot take part if they have serious vision problems, recent leg injuries, major illnesses, significant memory problems, or mental health conditions.

详细描述

This cluster-randomized controlled trial investigates the integration of interactive exergaming with the evidence-based Otago Exercise Program (OEP) to enhance mobility among community-dwelling older adults. The study employs comprehensive methodology and rigorous assessment protocols to evaluate intervention effectiveness.

Methodology and Technical Implementation:

Assessment Tools and Measurements:

Primary Outcome Measures:

ICOPE (Integrated Care for Older People) screening tool evaluating six domains: cognition, mobility, nutrition, vision, hearing, and depression

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)

盲法说明

The outcomes assessor who performs all measurements and evaluations will be blinded to group allocation throughout the study period. This assessor will not be involved in intervention delivery or have any contact with participants during exercise sessions to maintain masking

入排标准

年龄范围
65 Years 至 99 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 65 years
  • Abnormal mobility based on ICOPE screening (Five-time chair stand test > 12 seconds)
  • Able to stand holding handrail for > 30 seconds

排除标准

  • Severe visual impairment
  • Lower limb fracture
  • Acute serious illness
  • Moderate to severe cognitive impairment (SPMSQ > 5 errors)
  • Diagnosed psychiatric disorders

结局指标

主要结局

Mobility Performance

时间窗: Baseline, 12 weeks, 3 months

Measured by Short Physical Performance Battery (SPPB) Scale: 0-12 points, higher scores indicate better performance

Lower Extremity Strength

时间窗: Baseline, 12 weeks, 3 months

Measured by digital dynamometer Unit: Kilograms (kg)

次要结局

  • Intrinsic Capacity Score(baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2))
  • Loneliness Level(Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2))
  • Depression Symptoms(Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2))
  • Well-being Status(Measured at baseline (T0), post 12-week intervention (T1), and 3-month follow-up (T2))

研究者

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

JIA-JING SUN

PhD Candidate, Registered Nurse

National Taiwan University

研究点 (2)

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