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

NCT05168098 | Completed DMC

• 2 other identifiers: MOST 108-2410-H-003-128-201901HM030
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

• 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.

  60 min

Secondary Outcomes (4)

• Mini-mental State Examination

  60 min.

• Loewenstein Occupational Therapy Cognitive Assessment-Geriatric (LOTCA-G)

  60 min.

• The Top International Biotech Smell Identification Test (TIBSIT)

  60 min.

• Geriatric Depression Scale (GDS-15)

  60 min.

Study Arms (3)

olfactory intervention group

EXPERIMENTAL

Other: olfactory stimulation intervention

game comparison group

ACTIVE COMPARATOR

Other: board game comparison

control group

NO INTERVENTION

Interventions

board game comparison OTHER

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.

game comparison group

olfactory stimulation intervention OTHER

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

olfactory intervention group

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan Normal University: lead

Study Sites (1)

National Taiwan Normal University

Taipei, 106, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 36204759 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 23, 2021
• Study Start: October 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: January 31, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)