UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000027071
Receipt No. 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 (Ver. 11)

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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
Email 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
Email masuya@tmu.ac.jp

Sponsor
Institute Tokyo Metropolitan University, Graduate School of Human Health Sciences
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031033