UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054556 |
|---|---|
| Receipt number | R000062333 |
| Scientific Title | Effects verification of a combined program on social frailty in community-dwelling older adults |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2024/06/03 19:02:40 |
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Basic information
Public title
Effects verification of a combined program on social frailty in community-dwelling older adults
Acronym
Effects verification of a combined program on social frailty in community-dwelling older adults
Scientific Title
Effects verification of a combined program on social frailty in community-dwelling older adults
Scientific Title:Acronym
Effects verification of a combined program on social frailty in community-dwelling older adults
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the prevalence of social frailty among community-dwelling older adults and to examine whether a combined program that includes gardening is an effective intervention for social frailty.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Social frailty assessment tool
Before and after intervention and After
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Forty community-dwelling older adults subjects were randomly divided into two groups: Group A (exercise,20 participants) and Group B (horticulture/gardening,20 participants).Period 1 (3 months), Group A will focus on aerobic and cognicise.Group B will focus on horticulture and gardening, including environmental improvement.There will be a three-month washout period, and period 2 (three months), Group A will engage in "horticultural gardening" and Group B will engage in "exercise."
Group A:exercise
Interventions/Control_2
Group B:horticultural/gardening
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
Community-dwelling older adults who given written informed consent
Key exclusion criteria
1 history of cerebrovascular disease or parkinson disease or dementia or depression
2 missing data
3 Persons who are objectively judged to lack the ability to give informed consent
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hironori |
| Middle name | |
| Last name | Miyata |
Organization
Kumamoto Health Science University
Division name
Department of Rehabilitation
Zip code
8615598
Address
325 Izumi-machi, Kita-ku, Kumamoto City
TEL
09047701880
miyata.h01@kumamoto-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Miyata |
Organization
Kumamoto Health Science University
Division name
Department of Rehabilitation
Zip code
8615598
Address
325 Izumi-machi, Kita-ku, Kumamoto City
TEL
0962752112
Homepage URL
miyata.h01@kumamoto-hsu.ac.jp
Sponsor or person
Institute
Kumamoto Health Science University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Health Science University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University of Health Science Life Science Ethics Review Committee
Address
325 Izumi-machi, Kita-ku, Kumamoto-shi, Kumamoto
Tel
0962752112
kikaku@kumamoto-hsu.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
| 2024 | Year | 06 | Month | 04 | 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
40
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
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062333
