UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027071 |
|---|---|
| Receipt number | R000031033 |
| Scientific Title | The effect of a horticultural activities program for the community elderly |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2020/04/07 13:56:20 |
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Basic information
Public title
The effect of a horticultural activities program for the community elderly
Acronym
The effect of a horticultural activities program for the community elderly
Scientific Title
The effect of a horticultural activities program for the community elderly
Scientific Title:Acronym
The effect of a horticultural activities program for the community elderly
Region
| Japan |
Condition
Condition
the community elderly
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o examined the effects of a horticultural activities program on the psychologic, physical, and cognitive function and quality of life in the community elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The Vitality Index (VI), the Geriatric Depression Scale (GDS-15), the Activities of Daily Living (ADL-20) scale, quality of life (QOL), and the Mini-Mental State Examination (MMSE), before and after the intervention (6-week after).
Key secondary outcomes
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
The community elderly people were invited to participate in a 6-week horticultural activities program. The Vitality Index (VI), the Geriatric Depression Scale (GDS-15), the Activities of Daily Living (ADL-20) scale, quality of life (QOL), and the Mini-Mental State Examination (MMSE), before and after the intervention (6-week after).
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
over 65 years of age or older
Key exclusion criteria
no diagnosis of dementia by a physician
no speech or vision disorders
no participation in other research studies
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Masuya |
Organization
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Division name
Gerontological Nursing
Zip code
116-8551
Address
7-2-10 Higashiogu, Arakawa-ku,
TEL
03-3819-7342
masuya@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Masuya |
Organization
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Division name
Gerontological Nursing
Zip code
116-8551
Address
7-2-10 Higashiogu, Arakawa-ku,
TEL
03-3819-7342
Homepage URL
masuya@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan University, Graduate School of Human Health Sciences
Address
7-2-10 Higashiogu, Arakawa-ku,
Tel
03-3819-1211
rinri-hs@tmu.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
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
The community elderly were invited to participate in a 6-weeks horticultural activities program.Regarding QOL, the participants exhibited a significant improvement in mood, life satisfaction, degree of happiness, after the intervention. Regarding GDS-15 score, the participants exhibited a significant decrease after the intervention. TMIG-IC, and MMSE scores remained unchanged after the intervention.
Results date posted
| 2019 | Year | 06 | Month | 11 | Day |
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 19 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031033
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
