UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000063025 |
|---|---|
| Receipt number | R000072150 |
| Scientific Title | Feasibility and Psychological Effects of Horticultural Therapy in a Community-Based Integrated Care Ward: A Preliminary Study Using a Multiple-Baseline Design |
| Date of disclosure of the study information | 2026/10/31 |
| Last modified on | 2026/09/23 12:09:27 |
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Basic information
Public title
A Study of Horticultural Therapy and Its Psychological Effects in a Community-Based Integrated Care Ward
Acronym
Horticultural Therapy Study in a Community-Based Integrated Care Ward
Scientific Title
Feasibility and Psychological Effects of Horticultural Therapy in a Community-Based Integrated Care Ward: A Preliminary Study Using a Multiple-Baseline Design
Scientific Title:Acronym
Horticultural Therapy Feasibility Study
Region
| Japan |
Condition
Condition
Patients aged 60 years or older hospitalized in a community-based integrated care ward
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to exploratorily investigate the effects of horticultural therapy on psychological well-being and health-related quality of life in older patients hospitalized in a community-based integrated care ward, and to preliminarily evaluate its feasibility.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in mood assessed using a Visual Analogue Scale (VAS). The VAS will be measured on each weekday at approximately the same time in the morning throughout the baseline and intervention periods. On horticultural therapy days, additional VAS measurements will be performed immediately before and after the intervention.
Key secondary outcomes
Mental well-being (WHO-5 Well-Being Index), loneliness (UCLA Loneliness Scale), health-related quality of life (EQ-5D), activities of daily living (Functional Independence Measure: FIM), and feasibility of the intervention (participation rate, completion rate, reasons for discontinuation or dropout, adverse events, implementation time, and material costs). EQ-5D, WHO-5 Well-Being Index, UCLA Loneliness Scale, and FIM will be assessed at the beginning of the baseline period and at the end of the intervention period. If a participant is discharged during the study period, the final assessment will be conducted at discharge.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
A baseline period of 3, 5, or 7 days will be established for each participant. During the baseline period, the horticultural therapy specified in this study will not be provided, while usual medical care and rehabilitation will continue. After the baseline period, horticultural therapy will be conducted in a rooftop garden for approximately 20-30 minutes per session, 2-3 times per week, for 1-2 weeks. Activities may include sowing seeds, planting seedlings, repotting, watering, plant care, deadheading, and harvesting. Activities will be selected according to each participant's physical and cognitive function and health condition on the day, with supervision or assistance from research staff as needed.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 60 years or older admitted to the community-based integrated care ward of the Kawasaki Geriatric Medical Center.
Key exclusion criteria
1) Patients with marked cognitive impairment (Mini-Cog score of 2 or less) or impaired consciousness.
2) Patients with a history of a diagnosed psychiatric disorder.
3) Patients whose participation in group activities is restricted for infection-control reasons, such as due to an infectious disease.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Kuyama |
Organization
Kawasaki Geriatric Medical Center
Division name
Rehabilitation Center
Zip code
700-0821
Address
2-1-80 Nakayamashita, Kita-ku, Okayama, 700-0821, Japan
TEL
086-201-5280(ext.41500)
j.kuyama@hp.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Kuyama |
Organization
Kawasaki Geriatric Medical Center
Division name
Rehabilitation Center
Zip code
700-0821
Address
2-1-80 Nakayamashita, Kita-ku, Okayama, 700-0821, Japan
TEL
086-201-5280(ext.41500)
Homepage URL
j.kuyama@hp.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Geriatric Medical Center
Institute
Department
Personal name
Funding Source
Organization
The KAWASAKI Foundation for Medical Science and Medical Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School / Hospital Ethics Committee
Address
577 Matsushima, Kurashiki, Okayama 701-0192, Japan
Tel
086-464-1076
kmsrec@med.kawasaki-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072150
