UMIN-CTR Clinical Trial

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
Email	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
Email	k.hagihara@imed3.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046523