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Acupressure on Cognitive Function and Quality of Life

T

Taipei Medical University

Status

Unknown

Conditions

Cognitive Dysfunction

Treatments

Other: Acupressure

Study type

Interventional

Funder types

Other

Identifiers

NCT04441645
108MOST

Details and patient eligibility

About

The study aims to (1)compare differences of global cognitive function, working memory, executive function, language function, and quality of life between institutionalized older adults with MCI and with mild AD. Doing so, we can have a better understanding of the cognitive performance and life quality at pre-dementia and dementia;(2)explore the effects of the interventions with different acupoints(acupoints on head, acupoints on body, and acupoints on head and body) on global cognitive function, working memory, executive function, language function, and quality of life among institutionalized older adults with MCI and with mild AD;(3) further investigate the long-term effects of the interventions on global cognitive function, working memory, executive function, language function, and quality of life among institutionalized older adults with MCI and with mild AD; doing this, we can explore the pathological mechanism of the changes in the cognitive function through neuropsychological assessments and the association between the changes in cognitive function and in quality of life. We will recruit 32 residential care homes, with 256 older adults with MCI and with mild AD for this single blind cluster randomized controlled trial with repeated measures study. The facilities will be randomly assigned to the acupoint-on-head group, acupoint-on-body group, acupoint-on-head-and-body group and control group, with a ratio of 1:1:1:1. Interventions are developed based on the theory of Chinese medicine. Except routine care, the intervention groups will receive the acupressure once per day, five times per week, a total of 12 weeks. Data will be collected at baseline, the 4th and 8th weeks during the intervention, the end of the intervention, and the1st, 4th, and 8th months after the intervention. The control group only will receive routine care and data collection is the same as the intervention groups. Data assessors will not involve in the interventions and not know the group allocation. The data analysis will use intent-to-treat analysis. The multiple regression analysis, mixed effect model for repeated measure analysis, subgroup analysis, and product-of-coefficient test will be performed to examine the effects of the interventions on cognitive function and quality of life, and the associations among the changes in the dependent variables.

Full description

Although evidence has demonstrated that acupressure effectively improves older patients' symptoms (e.g., sleep disturbance, behavior and psychological symptoms of dementia, etc.), it is still lack of the study to investigate the effect of the acupressure on cognitive function and quality of life among older adults with cognitive impairment in long-term care settings and its long-term effects. In addition, according to statistical data for epidemiological investigation, the majority is people with mild cognitive impairment (MCI) and mild dementia (mild AD); hence, it is vital to prevent these two groups from having dementia or getting worse. The study aims to (1)compare differences of global cognitive function, working memory, executive function, language function, and quality of life between institutionalized older adults with MCI and with mild AD. Doing so, we can have a better understanding of the cognitive performance and life quality at pre-dementia and dementia;(2)explore the effects of the interventions with different acupoints(acupoints on head, acupoints on body, and acupoints on head and body) on global cognitive function, working memory, executive function, language function, and quality of life among institutionalized older adults with MCI and with mild AD;(3) further investigate the long-term effects of the interventions on global cognitive function, working memory, executive function, language function, and quality of life among institutionalized older adults with MCI and with mild AD; doing this, we can explore the pathological mechanism of the changes in the cognitive function through neuropsychological assessments and the association between the changes in cognitive function and in quality of life. This single blind cluster randomized controlled trial with repeated measures study will complete in 2 years. We will recruit 32 residential care homes in Taipei City, with 256 older adults with MCI and with mild AD. The facilities will be randomly assigned to the acupoint-on-head group, acupoint-on-body group, acupoint-on-head-and-body group and control group, with a ratio of 1:1:1:1. Interventions are developed based on the theory of Chinese medicine and the trained research assistants, also having traditional Chinese nursing training, will perform the interventions. Except routine care, the intervention groups will receive the acupressure once per day, five times per week, a total of 12 weeks. Data will be collected at baseline, the 4th and 8th weeks during the intervention, the end of the intervention, and the1st, 4th, and 8th months after the intervention. The control group only will receive routine care and data collection is the same as the intervention groups. Data assessors will not involve in the interventions and not know the group allocation. The data analysis will use intent-to-treat analysis. The multiple regression analysis, mixed effect model for repeated measure analysis, subgroup analysis, and product-of-coefficient test will be performed to examine the effects of the interventions on cognitive function and quality of life, and the associations among the changes in the dependent variables. This study will promote the professional nursing autonomy and improve life quality of the institutionalized older adults.

Enrollment

256 estimated patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Mini-Mental State Examination (MMSE):20~28
  • Clinical Dementia Rating (CDR): 0.5~1

Exclusion criteria

  • CDR>1

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

256 participants in 4 patient groups

the acupoint-on-head group
Experimental group
Description:
pressing acupoints only on head
Treatment:
Other: Acupressure
the acupoint-on-body group
Experimental group
Description:
pressing acupoints only on body
Treatment:
Other: Acupressure
the acupoint-on-head-and-body group
Experimental group
Description:
pressing acupoints on head and body
Treatment:
Other: Acupressure
the control group
No Intervention group
Description:
routine care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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