Acupressure on Cognitive Function and Quality of Life
Primary Purpose
Cognitive Dysfunction
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupressure
Sponsored by
About this trial
This is an interventional supportive care trial for Cognitive Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Mini-Mental State Examination (MMSE):20~28
- Clinical Dementia Rating (CDR): 0.5~1
Exclusion Criteria:
- CDR>1
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
the acupoint-on-head group
the acupoint-on-body group
the acupoint-on-head-and-body group
the control group
Arm Description
pressing acupoints only on head
pressing acupoints only on body
pressing acupoints on head and body
routine care
Outcomes
Primary Outcome Measures
The Cognitive Abilities Screening Instrument
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.
Secondary Outcome Measures
The Digit Span Test
a key tool for working verbal memory.
The Wisconsin Card Sorting Test
a neuropsychological test of the ability to display flexibility in the face of changing schedules of reinforcement
Semantic Association of Verbal Fluency
the generation of words from a given category within a pre-set time of 60 seconds.
Quality of life-Alzheimer's disease scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04441645
Brief Title
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
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Dysfunction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
the acupoint-on-head group
Arm Type
Experimental
Arm Description
pressing acupoints only on head
Arm Title
the acupoint-on-body group
Arm Type
Experimental
Arm Description
pressing acupoints only on body
Arm Title
the acupoint-on-head-and-body group
Arm Type
Experimental
Arm Description
pressing acupoints on head and body
Arm Title
the control group
Arm Type
No Intervention
Arm Description
routine care
Intervention Type
Other
Intervention Name(s)
Acupressure
Intervention Description
acupressure once per day, five times per week, a total of 12 weeks
Primary Outcome Measure Information:
Title
The Cognitive Abilities Screening Instrument
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
The Digit Span Test
Description
a key tool for working verbal memory.
Time Frame
up to 12 months
Title
The Wisconsin Card Sorting Test
Description
a neuropsychological test of the ability to display flexibility in the face of changing schedules of reinforcement
Time Frame
up to 12 months
Title
Semantic Association of Verbal Fluency
Description
the generation of words from a given category within a pre-set time of 60 seconds.
Time Frame
up to 12 months
Title
Quality of life-Alzheimer's disease scale
Description
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.
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mini-Mental State Examination (MMSE):20~28
Clinical Dementia Rating (CDR): 0.5~1
Exclusion Criteria:
CDR>1
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
I-Hui Chen
Organizational Affiliation
Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Medical University
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
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Acupressure on Cognitive Function and Quality of Life
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