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临床试验/ChiCTR2100053912
ChiCTR2100053912招募中Unknown

Can whole-body vibration treatment optimize cognitive function in older adults who have sarcopenia and are at risk of dementia: A randomized controlled trial.

Health and Medical Research Fund1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2021年12月17日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
156
试验地点
1
主要终点
Global cognitive function

研究概览

简要总结

The objective is to ascertain if vibration treatment optimizes cognitive function in older adults who have sarcopenia and are at risk of dementia.

研究设计

研究类型
Interventional
主要目的
随机平行对照
盲法
None

入排标准

年龄范围
60 至 100(—)
性别
All

入选标准

  • Community-living Chinese individuals aged 60 or older with sarcopenia but without clinical dementia will be recruited from local elderly centres equipped with our vibration platform, V-Health. All individuals will be screened at our research centre (the Orthopaedic Learning Centre) for the following:
  • presence of sarcopenia, defined according to the latest diagnostic criteria published by the Asian Working Group of Sarcopenia (AWGS):
  • (1) hand-grip strength (male at < 28kg; female at < 18kg),
  • (2) 6-metre gait speed test (< 1.0m/s), and
  • (3) height-adjusted skeletal muscle mass measured by dual-energy X-ray absorptiometry (DXA, male at <7.0kg/m2 and female at < 5.4kg/m2), defined by appendicular skeletal muscle mass/height2
  • at risk of dementia, according to age- and education-matched cutoff of the Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA);
  • being able to stand independently without any aids; and
  • not receiving vibration treatment in the past 1 year.

排除标准

  • include non-Chinese ethnicity; living in care homes; having history of dementia, stroke, traumatic brain injury, epilepsy, or Parkinsons disease; taking drugs that affect cognition (benzodiazepines, anti-dementia medication, etc.); having history of severe mental illness (SMI), including bipolar affective disorder and schizophrenia, or substance abuse; already attending other cognitive intervention programs; significant impairments in communication; having any hormonal replacement therapy or drug treatment that could affect normal metabolism of musculoskeletal system; having any hypo- or hyperparathyroidism, renal, liver, or chronic inflammatory conditions known to affect muscle metabolism; having pacemaker or implant in situ; having difficulty in standing independently; and already having regular vibration treatment.

研究组 & 干预措施

Control group

12-week observation, followed by 12-week vibration intervention

Experimental group

12-week vibration intervention, followed by 12-week observation

结局指标

主要结局

Global cognitive function

次要结局

  • Cognitive domains
  • Efficiency of brain network

研究者

发起方
Health and Medical Research Fund

研究点 (1)

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