Mild Cognitive ImpairmentNCT03857269
Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions
A study testing Acupoint Massage, lavender essential oil and Acupoint Massage and lavender essential oil in people with Mild Cognitive Impairment, run by Huan Ding at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Acupoint Massage, lavender essential oil and Acupoint Massage and lavender essential oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2018to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese people aged 60 years or above;
- the MOCA screening score <26, which was corrected based on educational level (Education time <12, plus one point)
- ability to perform self-care functions on their own;
- no confirmed diagnosis of dementia, depression or other psychiatric illnesses which would interfere with cognitive performance;
- capacity to provide informed consent.
Who cannot join
- had a medical history of chronic alcoholism or brain trauma occurred in previous years that could interfere with cognition;
- had been regular users of medications that could affect cognition;
- had clinical conditions that contraindicated light to moderate physical exercise；
- any disabilities preventing participation in the MET or KY conditions (e.g. severe visual or hearing impairment);
- people with olfactory dysfunction or those who are allergic to lavender；
- skin is broken, can not be massaged；
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions: A Multicenter Clinical Trial
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Acupoint Massage, lavender essential oil, Acupoint Massage and lavender essential oil
- Keywords
- acupressure, Aromatherapy, Nursing Homes, china
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupoint MassageOther
Also called AM
The operators is trained for two weeks. At 9 o'clock in the morning, the elderly are organized by Nursing home to perform acupressure.Intervention frequency will be monday to saturday per week for 6 months.
lavender essential oilOther
Also called EO
Modulated by an international aroma therapist,The cotton ball containing essential oil is replaced by the operator at 9 am.Intervention frequency will be monday to saturday per week for 6 months.
Acupoint Massage and lavender essential oilOther
Also called AM&EO
At the same time as the acupressure, patients began to smell the essential oil.Intervention frequency will be monday to saturday per week for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Acupoint Massage group | Experimental | Choose Chinese medicine acupuncture points： Shenting, Baihui, Sishencong, Diwei, Chengling, Fengchi, Fengfu，Zusanli and Sanyinjiao，32 points per acupressure.32 times per acupoint.Intervention frequency will be monday to saturday per week for 6 months.（n=30） Receives: Other: Acupoint Massage |
| Aromatherapy group | Experimental | Make a 5x5cm bag and put a cotton ball in the bag and the bag is clipped to the patient's collar.Dispense 10% lavender essential oil, 2-3 drops a day in cotton balls.Cotton ball replacement daily. Intervention frequency will be monday to saturday per week for 6 months.（n=30） Receives: Other: lavender essential oil |
| Acupoint Massage and Aromatherapy group | Experimental | At the same time as the acupressure, the essential oil is applied to the collar and begins to sniff.Intervention frequency will be monday to saturday per week for 6 months.（n=30） Receives: Other: Acupoint Massage and lavender essential oil |
| Blank control group | No intervention | The group selects elderly people with MCI who do not receive intervention after informed.Participate in routine activities of Nursing homes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-mental State Examination
The table is simple and easy to use, widely used at home and abroad, and is the preferred scale for dementia screening. The scale includes the following seven aspects: time-orientation, location-orientation, immediate memory, attention and computational power, delayed memory, language, and visual space.The total score of the scale ranges from 0-30 points. The test scores are closely related to the cultural level. The normal boundary value is:uneducated people（>17）.primary school education（>20）, and middle high school or above（>24）, indicating good mental state. The higher the total score, the better the situation.
Measured: Change from baseline in Mini-mental State Examination at month 3 and month 6. To investigate the Intelligence state.
Wechsler Intelligence Scale
There are ten aspects of the scale. Consult relevant experts and consult literature, this program selects four aspects: logical memory(0~25), association learning(0~21), picture recall(0~20), and number of memories(0~17).Add the total scores, the higher the score, the better the memory.
Measured: Change from baseline in Wechsler Intelligence Scale at month 3 and month 6. To investigate the Memory capacity.
Secondary outcomes (2)
Geriatric depression scale
Dedicated to screening for depression in the elderly. The most suitable feelings for the elderly in the past week were evaluated. The scale has a total of thirty entries, including the following symptoms: low mood, reduced activity, irritability, retreat from painful thoughts, negative scores on past, present and future.The total score is 0-10 points, which is normal; 11-20 points, mild depression; 21-30 minutes, moderate to severe depression.
Measured: Change from baseline in Geriatric depression scale at month 3 and month 6. To investigate the Functional Activities status.
Pittsburgh sleep quality index
PSQI was used to assess the quality of sleep in the last month of the test. It consists of 19 self-evaluations and 5 other evaluation items. The 19th self-evaluation item and 5 other evaluation items do not participate in the scoring. Only 18 self-evaluation items participating in the scoring are introduced here. 18 items are composed of 7 components, each component is scored according to o~3 level, and the accumulated components are scored as PSQI total score, and the total score range is 0~2l. The higher the score, the worse the sleep quality. It takes 5 to 10 minutes for the subject to complete the test.
Measured: Change from baseline in Pittsburgh sleep quality index at month 3 and month 6. To investigate the Functional Activities status.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start27 Dec 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huan Ding
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huan Ding, Nanjing University of Traditional Chinese Medicine
- Investigators
- Huan Ding, Principal investigator, School of Nursing, Nanjing University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857269
- Sponsor's protocol ID
- KY2019002
- Status last verified
- Aug 2019
- First submitted
- 23 Feb 2019
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupoint Massage and Aromatherapy Intervention in Elderly People With Mild Cognitive Impairment in Nursing Institutions: A Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT03857269
- Acronym / sponsor ID
- KY2019002
- Conditions
- Mild Cognitive Impairment
- Keywords
- acupressure, Aromatherapy, Nursing Homes, china
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Huan DingUniversity, hospital or other
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 27 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acupoint Massage group | Experimental | Other: Acupoint MassageChoose Chinese medicine acupuncture points： Shenting, Baihui, Sishencong, Diwei, Chengling, Fengchi, Fengfu，Zusanli and Sanyinjiao，32 points per acupressure.32 times per acupoint.Intervention frequency will be monday to saturday per week for 6 months.（n=30） |
| Aromatherapy group | Experimental | Other: lavender essential oilMake a 5x5cm bag and put a cotton ball in the bag and the bag is clipped to the patient's collar.Dispense 10% lavender essential oil, 2-3 drops a day in cotton balls.Cotton ball replacement daily. Intervention frequency will be monday to saturday per week for 6 months.（n=30） |
| Acupoint Massage and Aromatherapy group | Experimental | Other: Acupoint Massage and lavender essential oilAt the same time as the acupressure, the essential oil is applied to the collar and begins to sniff.Intervention frequency will be monday to saturday per week for 6 months.（n=30） |
| Blank control group | No intervention | –The group selects elderly people with MCI who do not receive intervention after informed.Participate in routine activities of Nursing homes. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese people aged 60 years or above;
- the MOCA screening score <26, which was corrected based on educational level (Education time <12, plus one point)
- ability to perform self-care functions on their own;
- no confirmed diagnosis of dementia, depression or other psychiatric illnesses which would interfere with cognitive performance;
- capacity to provide informed consent.
Key exclusion criteria (6 listed)
- had a medical history of chronic alcoholism or brain trauma occurred in previous years that could interfere with cognition;
- had been regular users of medications that could affect cognition;
- had clinical conditions that contraindicated light to moderate physical exercise；
- any disabilities preventing participation in the MET or KY conditions (e.g. severe visual or hearing impairment);
- people with olfactory dysfunction or those who are allergic to lavender；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupoint MassageAlso: AMThe operators is trained for two weeks. At 9 o'clock in the morning, the elderly are organized by Nursing home to perform acupressure.Intervention frequency will be monday to saturday per week for 6 months. | Other | Acupoint Massage group |
| lavender essential oilAlso: EOModulated by an international aroma therapist,The cotton ball containing essential oil is replaced by the operator at 9 am.Intervention frequency will be monday to saturday per week for 6 months. | Other | Aromatherapy group |
| Acupoint Massage and lavender essential oilAlso: AM&EOAt the same time as the acupressure, patients began to smell the essential oil.Intervention frequency will be monday to saturday per week for 6 months. | Other | Acupoint Massage and Aromatherapy group |
Primary outcome
Mini-mental State Examination
Time frame: Change from baseline in Mini-mental State Examination at month 3 and month 6. To investigate the Intelligence state.
The table is simple and easy to use, widely used at home and abroad, and is the preferred scale for dementia screening. The scale includes the following seven aspects: time-orientation, location-orientation, immediate memory, attention and computational power, delayed memory, language, and visual space.The total score of the scale ranges from 0-30 points. The test scores are closely related to the cultural level. The normal boundary value is:uneducated people（>17）.primary school education（>20）, and middle high school or above（>24）, indicating good mental state. The higher the total score, the better the situation.
Wechsler Intelligence Scale
Time frame: Change from baseline in Wechsler Intelligence Scale at month 3 and month 6. To investigate the Memory capacity.
There are ten aspects of the scale. Consult relevant experts and consult literature, this program selects four aspects: logical memory(0~25), association learning(0~21), picture recall(0~20), and number of memories(0~17).Add the total scores, the higher the score, the better the memory.
2 secondary outcomes
Geriatric depression scale
Time frame: Change from baseline in Geriatric depression scale at month 3 and month 6. To investigate the Functional Activities status.
Pittsburgh sleep quality index
Time frame: Change from baseline in Pittsburgh sleep quality index at month 3 and month 6. To investigate the Functional Activities status.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huan Ding principal investigator
School of Nursing, Nanjing University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupoint Massage, lavender essential oil and Acupoint Massage and lavender essential oil in people with Mild Cognitive Impairment, run by Huan Ding at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-mental State Examination (time frame: Change from baseline in Mini-mental State Examination at month 3 and month 6. To investigate the Intelligence state.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.