Clinical trial NCT03857269: Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions
Official title: Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions: A Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: acupressure
Aromatherapy
Nursing Homes
china
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate and compare the intervention effects of acupressure,aromatherapy,combining acupressure and aromatherapy in elderly with mild cognitive impairment. The investigators hypothesize that (1) Combined intervention can induce greater improvements in the outcome measures than single mode of intervention; (2) the improvement in cognitive functions and other outcomes may differ between the groups.

Detailed description: Background and study aims:

Mild cognitive impairment (MCI) or minor neurocognitive disorder is a syndrome defined as an intermediate stage between cognitively intact and clinically diagnosed dementia. The progression rate from MCI to dementia ranges from 10 to 15% each year, and over 50% of the MCI population will develop into severe cognitive impairment or dementia in 5 years.MCI involves functional decline that may include decrements in engagement in meaningful activities and one's own sense of confidence/mastery, and it is associated with depressive symptoms, poor satisfaction with family communication, and declining physical function. Therefore, early detection of the individuals who manifest MCI and provide appropriate interventions may help reduce the burden of their caregivers and the medical expenses of the health-care system. Previous studies found that acupressure or aromatherapy has emerged as an important therapeutic approach for individuals with MCI. However, the intervention effects of combining acupressure or aromatherapy remain to be determined. Furthermore, whether acupressure and aromatherapy should be administered simultaneously is an important question to pursue. The overall goal of this study is to determine and compare the intervention effects acupressure,aromatherapy, and combining acupressure and aromatherapy in individuals with MCI.

Who can participate? Individuals with MCI (≥60).

What does the study involve? The participants will receive acupressure, aromatherapy, combining acupressure and aromatherapy randomly. Intervention frequency will be 5-6 times per week for 6 months. All participants will received pretreatment test, post treatment test, and a 1-month follow-up test.

What are the possible benefits and risks of participating? The possible benefits include improvement in cognitive, and daily functions. There are no risks for participating.

Where to conduct the study? The investigators anticipate recruiting a total of 120 participants from nursing homes from multiple areas in NanJing,china.

Eligibility criteria: Inclusion Criteria:

1. Chinese people aged 60 years or above;
2. the MOCA screening score \<26, which was corrected based on educational level (Education time \<12, plus one point)
3. ability to perform self-care functions on their own;
4. no confirmed diagnosis of dementia, depression or other psychiatric illnesses which would interfere with cognitive performance;
5. capacity to provide informed consent.

Exclusion Criteria:

1. had a medical history of chronic alcoholism or brain trauma occurred in previous years that could interfere with cognition;
2. had been regular users of medications that could affect cognition;
3. had clinical conditions that contraindicated light to moderate physical exercise；
4. any disabilities preventing participation in the MET or KY conditions (e.g. severe visual or hearing impairment);
5. people with olfactory dysfunction or those who are allergic to lavender；
6. skin is broken, can not be massaged；

Primary outcomes:
measure: Mini-mental State Examination
timeFrame: Change from baseline in Mini-mental State Examination at month 3 and month 6. To investigate the Intelligence state.
measure: Wechsler Intelligence Scale
timeFrame: Change from baseline in Wechsler Intelligence Scale at month 3 and month 6. To investigate the Memory capacity.
Secondary outcomes:
measure: Geriatric depression scale
timeFrame: Change from baseline in Geriatric depression scale at month 3 and month 6. To investigate the Functional Activities status.
measure: Pittsburgh sleep quality index
timeFrame: Change from baseline in Pittsburgh sleep quality index at month 3 and month 6. To investigate the Functional Activities status.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing University of Chinese Medicine
state: Jiangsu
Study officials:
affiliation: School of Nursing, Nanjing University of Traditional Chinese Medicine
name: Huan Ding
role: PRINCIPAL_INVESTIGATOR
References: