Acupressure on Cognitive Function and Quality of Life

NCT04441645 | Unknown

• 1 other identifier: 108MOST
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 12 months

Secondary Outcomes (4)

• The Digit Span Test

  up to 12 months

• The Wisconsin Card Sorting Test

  up to 12 months

• Semantic Association of Verbal Fluency

  up to 12 months

• Quality of life-Alzheimer's disease scale

  up to 12 months

Study Arms (4)

the acupoint-on-head group

EXPERIMENTAL

pressing acupoints only on head

Other: Acupressure

the acupoint-on-body group

EXPERIMENTAL

pressing acupoints only on body

Other: Acupressure

the acupoint-on-head-and-body group

EXPERIMENTAL

pressing acupoints on head and body

Other: Acupressure

the control group

NO INTERVENTION

routine care

Interventions

Acupressure OTHER

acupressure once per day, five times per week, a total of 12 weeks

the acupoint-on-body group; the acupoint-on-head group; the acupoint-on-head-and-body group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• CDR\>1

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• I-Hui Chen

  Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: August 1, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: June 22, 2020

Record last verified: 2020-06

Locations

TW (1)