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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029634
Receipt No. R000030957
Scientific Title The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Date of disclosure of the study information 2017/10/20
Last modified on 2019/10/22

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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
Middle name
Last name Yutaka Kimura
Organization Kansai Medical University
Division name Health Science
Zip code
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
Middle name
Last name Nagisa Hidaka
Organization 1)Osaka Sangyo University, 2)Kansai Medical University
Division name 1)Faculty of International Studies, 2)Health Science
Zip code
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
Address
Tel
Email

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 Enrolling by invitation
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
2019 Year 10 Month 22 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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