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Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
board game comparison
olfactory stimulation intervention
Sponsored by
National Taiwan Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ages >50 years with a diagnosis of mild or moderate dementia
  • being admitted to the day care center and living in the community
  • being willing to do blood test with a family member's consent.

Exclusion Criteria:

  • experience in chronic rhinitis or sinusitis, which causes loss of smell; inability to perform the cognitive exam or olfactory test (e.g., having a severe hearing impairment)
  • inability to attend group activities due to severe emotional or aggressive behaviors

Sites / Locations

  • National Taiwan Normal University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

olfactory intervention group

game comparison group

control group

Arm Description

Outcomes

Primary Outcome Measures

ImmunoMaggnetic-Reduction (IMR) blood tests
A registered nurse drew 5 cc of blood from each participant twice, including pretest and posttest by the following procedure: Step 1: Plasma preparation 10-ml K3 EDTA tubes were used for collecting blood, immediately followed by gently inverting each blood tube 10 times. Blood tubes were centrifuged at room temperature at 2500g for 15 minutes with an aid of a swing-out (backet) rotor. Every 1-ml plasma (supernatant) was transferred to a fresh 1.5-ml eppendorf using a disposable 1-ml micropipette tip. All the plasma samples were frozen at -80 °C before measurements. Step 2: Assays of plasma biomarkers IMR kits were used in assaying amyloid B 1-42 and tau protein (Tau). For assaying AB1-42, 60-ul reagent was mixed with 60-ul plasma. For assaying Tau, 80-ul reagent was mixed with 40-ul plasma. Duplicated measurements were conducted for each biomarker per plasma sample. The average value of the duplicated measured concentrations is reported.

Secondary Outcome Measures

Mini-mental State Examination
All the participants were received the interview of MMSE twice, including pretest and posttest. A trained research assistant performed the test face to face. The MMSE is a widely used tool for clinical evaluation, with five major domains (orientation, registration, attention and calculation, recall, language). The examination is composed of 11 questions; the score ranges from 0 to 30, with a higher score indicating better cognitive function.
Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
All the participants were received the interview of LOTCA-G twice, including pretest and posttest. A trained research assistant performed the test face to face. The LOTCA-G, a modified version of the LOTCA for adults aged >70 years or for clients with a slower response to cognitive tasks, contains 23 subsets in 7 cognitive areas (orientation, visual perception, spatial perception, praxis, visuomotor organization, thinking operations, memory). Each question is scored from 1 (severe deficit) to 4 (average performance), with scores ranging from 23 to 100, with higher scores indicating better cognitive performance (Erez & Katz, 2004). LOTCA-G, a well-established test of discriminant validity for individuals with dementia, can be used to monitor changes in cognitive function during an intervention.
The Top International Biotech Smell Identification Test (TIBSIT)
All the participants were received the interview of TIBSIT twice, including pretest and posttest. TIBSIT, which consists of 16 tests (1 odor for 2 repeated tests) and a questionnaire, has 8 odors relevant for the Taiwanese population. Each participant completed the test with the assistance of a trained research assistant, if necessary. Within a test, the participant scratches the paper off the fragrant microcapsules using a pencil, smells the fragrance, and then answers two questions. The first question is a single choice from among four answers to identify the closest name of the odor, and the second is a three-item choice of not detectable (smell nothing, 0 points); detectable, but not sure (can smell something but unsure, 1 point); and detectable (can smell and know exactly what it is, 2 points). A total of 48 points are available for 16 tests.
Geriatric Depression Scale (GDS-15)
All the participants were received the interview of GDS-15 twice, including pretest and posttest. A trained research assistant performed the test face to face. GDS-15, a 15-item, short, easy-to-conduct questionnaire, to assess participants' emotional changes during the intervention. The answers are reported on a yes-no scale; the total scores range from 0 to 15, with higher scores indicating more severe depression.

Full Information

First Posted
December 8, 2021
Last Updated
December 22, 2021
Sponsor
National Taiwan Normal University
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1. Study Identification

Unique Protocol Identification Number
NCT05168098
Brief Title
Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy
Official Title
Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan Normal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to examine the effect of the olfactory stimulation intervention on the people with mild to moderate dementia. We recruit 28 participants who has been diagnosed with mild to moderate dementia from 2 day care centers in Taipei. They are randomly assigned to three groups, including the olfactory intervention group, game comparison group, and control group. Beside the control group, the participant with two other groups were required to attend twelve weeks intervention (twice a week, thirty minutes for one section). Every participants completed the olfactory test, both paper-pencil and computer-based examination for cognition, blood test and psychological measurement before and after the intervention. The results showed that the participant in olfactory intervention group significant improved score in the LOTCA-G examination, and the Aβ1-42 concentration of the blood test significant increase in the control group; furthermore, the olfactory intervention group is lowest concentration among three groups in the Tau concentration of the blood test via ANCOVA analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
olfactory intervention group
Arm Type
Experimental
Arm Title
game comparison group
Arm Type
Active Comparator
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
board game comparison
Intervention Description
The group used 24 board games popular among the elderly population in Taiwan, including Noah's Ark, Splash Attack, Pengoloo, Speedy, and Zingo. Because some games were too complicated for the participants to play, some game rules were modified into more simple and directive thinking.
Intervention Type
Other
Intervention Name(s)
olfactory stimulation intervention
Intervention Description
The group used 15 flavors of essential oil (i.e., lavender, rosemary, sweet orange, lemongrass, mint, and hinoki) and essence (i.e., lemon, coffee, peach, magnolia, chocolate, jasmine, strawberry, pomelo, and passion fruit), purposefully selecting two to three flavors for each session. Because some flavors are familiar to the participants and some are not, the familiar flavors were initially used to trigger memory. The unfamiliar flavors (i.e., lavender, rosemary, sweet orange, and lemon) were used in later sessions because those were recognized as having potential effects on cognitive function
Primary Outcome Measure Information:
Title
ImmunoMaggnetic-Reduction (IMR) blood tests
Description
A registered nurse drew 5 cc of blood from each participant twice, including pretest and posttest by the following procedure: Step 1: Plasma preparation 10-ml K3 EDTA tubes were used for collecting blood, immediately followed by gently inverting each blood tube 10 times. Blood tubes were centrifuged at room temperature at 2500g for 15 minutes with an aid of a swing-out (backet) rotor. Every 1-ml plasma (supernatant) was transferred to a fresh 1.5-ml eppendorf using a disposable 1-ml micropipette tip. All the plasma samples were frozen at -80 °C before measurements. Step 2: Assays of plasma biomarkers IMR kits were used in assaying amyloid B 1-42 and tau protein (Tau). For assaying AB1-42, 60-ul reagent was mixed with 60-ul plasma. For assaying Tau, 80-ul reagent was mixed with 40-ul plasma. Duplicated measurements were conducted for each biomarker per plasma sample. The average value of the duplicated measured concentrations is reported.
Time Frame
60 min
Secondary Outcome Measure Information:
Title
Mini-mental State Examination
Description
All the participants were received the interview of MMSE twice, including pretest and posttest. A trained research assistant performed the test face to face. The MMSE is a widely used tool for clinical evaluation, with five major domains (orientation, registration, attention and calculation, recall, language). The examination is composed of 11 questions; the score ranges from 0 to 30, with a higher score indicating better cognitive function.
Time Frame
60 min.
Title
Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)
Description
All the participants were received the interview of LOTCA-G twice, including pretest and posttest. A trained research assistant performed the test face to face. The LOTCA-G, a modified version of the LOTCA for adults aged >70 years or for clients with a slower response to cognitive tasks, contains 23 subsets in 7 cognitive areas (orientation, visual perception, spatial perception, praxis, visuomotor organization, thinking operations, memory). Each question is scored from 1 (severe deficit) to 4 (average performance), with scores ranging from 23 to 100, with higher scores indicating better cognitive performance (Erez & Katz, 2004). LOTCA-G, a well-established test of discriminant validity for individuals with dementia, can be used to monitor changes in cognitive function during an intervention.
Time Frame
60 min.
Title
The Top International Biotech Smell Identification Test (TIBSIT)
Description
All the participants were received the interview of TIBSIT twice, including pretest and posttest. TIBSIT, which consists of 16 tests (1 odor for 2 repeated tests) and a questionnaire, has 8 odors relevant for the Taiwanese population. Each participant completed the test with the assistance of a trained research assistant, if necessary. Within a test, the participant scratches the paper off the fragrant microcapsules using a pencil, smells the fragrance, and then answers two questions. The first question is a single choice from among four answers to identify the closest name of the odor, and the second is a three-item choice of not detectable (smell nothing, 0 points); detectable, but not sure (can smell something but unsure, 1 point); and detectable (can smell and know exactly what it is, 2 points). A total of 48 points are available for 16 tests.
Time Frame
60 min.
Title
Geriatric Depression Scale (GDS-15)
Description
All the participants were received the interview of GDS-15 twice, including pretest and posttest. A trained research assistant performed the test face to face. GDS-15, a 15-item, short, easy-to-conduct questionnaire, to assess participants' emotional changes during the intervention. The answers are reported on a yes-no scale; the total scores range from 0 to 15, with higher scores indicating more severe depression.
Time Frame
60 min.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ages >50 years with a diagnosis of mild or moderate dementia being admitted to the day care center and living in the community being willing to do blood test with a family member's consent. Exclusion Criteria: experience in chronic rhinitis or sinusitis, which causes loss of smell; inability to perform the cognitive exam or olfactory test (e.g., having a severe hearing impairment) inability to attend group activities due to severe emotional or aggressive behaviors
Facility Information:
Facility Name
National Taiwan Normal University
City
Taipei
ZIP/Postal Code
106
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36204759
Citation
Lin LJ, Li KY. Comparing the effects of olfactory-based sensory stimulation and board game training on cognition, emotion, and blood biomarkers among individuals with dementia: A pilot randomized controlled trial. Front Psychol. 2022 Sep 20;13:1003325. doi: 10.3389/fpsyg.2022.1003325. eCollection 2022.
Results Reference
derived

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Impact of the Olfactory Stimulation on the People With Mild Dementia Via the Horticultural Therapy

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