UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043996 |
|---|---|
| Receipt number | R000046523 |
| Scientific Title | Development of a new resilience scale and investigation of the relationship between resilience and lifestyle |
| Date of disclosure of the study information | 2021/12/17 |
| Last modified on | 2021/12/17 22:34:00 |
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Basic information
Public title
Development of a new resilience scale and investigation of the relationship between resilience and lifestyle
Acronym
Development of a new resilience scale and investigation of the relationship between resilience and lifestyle
Scientific Title
Development of a new resilience scale and investigation of the relationship between resilience and lifestyle
Scientific Title:Acronym
Development of a new resilience scale and investigation of the relationship between resilience and lifestyle
Region
| Japan |
Condition
Condition
Helthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of a new resilience scale based on realibility and validity assessment
Basic objectives2
Others
Basic objectives -Others
Investigation of the relationship between mind, body, lifestyle and gut
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Realibility and validity assessment of a new resilience scale depend on the following;
1.Center for Epidemiologic Studies -Depression Scale
2.Rosenberg Self-Esteem Scale
3.Wagnild & Young Resilience Scale
4.Social Support Questionnaire
5.SF-8
6.Perceived Stress Scale
7.Jinkyo score
Key secondary outcomes
Interrelationship between a new resilience scale and the following;
1. Physical examination(ex, hand grip strength, two-step test, body composition analysis, walking speed)
2. Lifestyle
3. Gut microbiota
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Males and females over 18 years olds
Key exclusion criteria
1. Subjects who have under treatment or a history of serious disease (e.g., cancer, stroke, or heart disease)
2. Subjects who are judged inappropriate to enroll in this study by the investigator
Target sample size
185
Research contact person
Name of lead principal investigator
| 1st name | Keiuske |
| Middle name | |
| Last name | Hagihara |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of advanced hybrid medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6210-8349
k.hagihara@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Hagihara |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of advanced hybrid medicine
Zip code
565-0871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
06-6210-8349
Homepage URL
k.hagihara@imed3.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.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
| 2021 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Subjects who agree with the contents of the study at the department of advanced hybrid medicine in Osaka University, Sango-cho in Nara or Maeda clinic in Osaka are included.
The psychiatric evaluation (eg, CES-D, a new resilience scale), physical examination (eg, hand grip strength, body composition) and lifestyle questionnaire are investigated at the first visit. The subjects are follow-up at 1 and 2 years.
Management information
Registered date
| 2021 | Year | 04 | Month | 21 | Day |
Last modified on
| 2021 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046523
