UMIN-CTR Clinical Trial

Basic information
Public title	The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Acronym	The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Scientific Title	The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Scientific Title:Acronym	The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Region	Japan

Condition
Condition	1. metabolic syndrome 2. obesity,
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Studying the connection between data on continuous bodily activity (including sleep) measured using a wristband-type physical activity meter and psychological indices related to depression and fatigue, and then studying whether psychological states related to depression and fatigue are analogous based on physical activity.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Collect continuous activity records for bodily movements and sleep (amount of exercise, exercise time, sustained exercise time, exercise intensity, exercise patterns, diurnal cycles, weekly cycles, exercise normality, non-normality (=irregularity), sleep time, sleep start time, sleep latency, sleep depth), and then study the connection between to the physical and psychological secondary endpoints below, as well as the amount of change after six-month intervention.
Key secondary outcomes	1.Body composition (inBody720) 2.Arteriosclerosis risk factors 3.Saliva amylase 4.Blood (peripheral blood figure, blood glucose, HbA1c, lipids, hepatic function, renal function) 5.BDI-II(Beck depression questionnaire-II) 6.PHQ9 (Patient Health Questionnaire-9) 7.CES-D (depression self-assessment scale) 8.TEG-II(Tokyo University Egogram New Ver. II) 9.NEO-FFI (NEO-FFI personality test) 10.POMS2 (Profile of Mood States 2nd Edition)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	Diet and exercise counseling given once monthly for six months while wearing physical activity meter
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Independent person 20 years or older at time of consent 2.Is receiving lifestyle disease counseling at health sciences center 3.Understands the tools, tests and other elements of this study, and is capable of using and implementing them 4.Has received a full explanation of participation in this study and given their written consent of their own accord
Key exclusion criteria	1.Person for whom spontaneous physical activity is difficult 2.Is being treated with antidepressants and antipsychotics, and has cranial neuropathy 3.Is receiving unstable treatment for diabetes, hypertension, etc. 4.Has otherwise been deemed unsuitable as a research subject by an investigator
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Kimura
Organization	Kansai Medical University
Division name	Health Science
Zip code	573-1010
Address	2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan
TEL	072-804-0101
Email	kimuray@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Nagisa Middle name Last name Hidaka
Organization	1)Osaka Sangyo University, 2)Kansai Medical University
Division name	1)Faculty of International Studies, 2)Health Science
Zip code	574-8530
Address	1)3-1-1 Nakagaito, Daito City, Osaka 574-853,2)2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan
TEL	(1)072-875-3001-(2)072-804-0101
Homepage URL
Email	hidaka@int.osaka-sandai.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	None
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	Kansai Medical University
Address	2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan
Tel	072-804-0101
Email	rinriirb@hirakata.kmu.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 10 Month 20 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	Completed
Date of protocol fixation	2017 Year 10 Month 20 Day
Date of IRB	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 10 Month 20 Day
Last follow-up date	2020 Year 10 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 10 Month 20 Day
Last modified on	2021 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030957