【ChiCTR2100053912】Can whole-body vibration treatment optimize cognitive function in older adults who have sarcopenia and are at risk of dementia: A randomized controlled trial.

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基本信息

登记号

ChiCTR2100053912

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2021-12-02

临床申请受理号

靶点

适应症

Dementia

试验通俗题目

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

试验专业题目

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

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临床试验信息

试验目的

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

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试验类型

随机平行对照

试验分期

其它

随机化

In the randomization procedure, each participant will be assigned a special code generated by a computer. The statistician of the department will perform all the randomization and will not be involved in enrollment or outcome assessment.

盲法

Outcome assessor will be blinded. Participants are assumed to be not blinded; nevertheless, they will be reimnded not to tell the assessors about their group allocation. Research staff will not be involved in outcome assessment.

试验项目经费来源

Health and Medical Research Fund

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-12-17

试验终止时间

2023-12-16

是否属于一致性

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: 1. 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 2. at risk of dementia, according to age- and education-matched cutoff of the Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA); 3. being able to stand independently without any aids; and 4. not receiving vibration treatment in the past 1 year.；

排除标准

Exclusion criteria 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.；

研究者信息

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试验机构

Health and Medical Research Fund

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