Clinical trial NCT04441645: Acupressure on Cognitive Function and Quality of Life
Official title: Effects of Acupressure Intervention on Cognitive Function and Quality of Life in Older Adults With Cognitive Impairment in Long-term Care Settings: A Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Dysfunction
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 256
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* CDR\>1

Primary outcomes:
measure: The Cognitive Abilities Screening Instrument
timeFrame: up to 12 months
Secondary outcomes:
measure: The Digit Span Test
timeFrame: up to 12 months
measure: The Wisconsin Card Sorting Test
timeFrame: up to 12 months
measure: Semantic Association of Verbal Fluency
timeFrame: up to 12 months
measure: Quality of life-Alzheimer's disease scale
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University
name: I-Hui Chen
role: PRINCIPAL_INVESTIGATOR
References: