- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04441645
Acupressure on Cognitive Function and Quality of Life
June 18, 2020 updated by: I-Hui-Chen 陳逸卉, Taipei Medical University
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
256
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 110
- Taipei Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mini-Mental State Examination (MMSE):20~28
- Clinical Dementia Rating (CDR): 0.5~1
Exclusion Criteria:
- CDR>1
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: the acupoint-on-head group
pressing acupoints only on head
|
acupressure once per day, five times per week, a total of 12 weeks
|
EXPERIMENTAL: the acupoint-on-body group
pressing acupoints only on body
|
acupressure once per day, five times per week, a total of 12 weeks
|
EXPERIMENTAL: the acupoint-on-head-and-body group
pressing acupoints on head and body
|
acupressure once per day, five times per week, a total of 12 weeks
|
NO_INTERVENTION: the control group
routine care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Cognitive Abilities Screening Instrument
Time Frame: up to 12 months
|
a cognitive test screening for dementia in providing profiles of cognitive impairment by examining abilities on attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, list-generating fluency, abstraction, and judgment with score ranges of 0 to 100, respectively.
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Digit Span Test
Time Frame: up to 12 months
|
a key tool for working verbal memory.
|
up to 12 months
|
The Wisconsin Card Sorting Test
Time Frame: up to 12 months
|
a neuropsychological test of the ability to display flexibility in the face of changing schedules of reinforcement
|
up to 12 months
|
Semantic Association of Verbal Fluency
Time Frame: up to 12 months
|
the generation of words from a given category within a pre-set time of 60 seconds.
|
up to 12 months
|
Quality of life-Alzheimer's disease scale
Time Frame: up to 12 months
|
The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole).
Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
|
up to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: I-Hui Chen, Taipei Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2019
Primary Completion (ANTICIPATED)
July 31, 2021
Study Completion (ANTICIPATED)
July 31, 2021
Study Registration Dates
First Submitted
June 18, 2020
First Submitted That Met QC Criteria
June 18, 2020
First Posted (ACTUAL)
June 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 22, 2020
Last Update Submitted That Met QC Criteria
June 18, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108MOST
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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