UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study assessing changes in mental state and mood based on continuous longitudinal physical activity, exercise, and sleep habits
Title of the study (Brief title)	A study assessing changes in mental state and mood based on continuous longitudinal physical activity, exercise, and sleep habits
Region	Japan

Condition
Condition	Obese outpatients, cardiac rehabilitation patients, and those who score high on stress check
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To measure levels of physical activity using wristband activity trackers in obese outpatients, cardiac rehabilitation patients, and those who score high on stress check. The relationships between the measured activity data and psychological indices/lifestyle habits will be assessed to find whether physical activity can be used to infer psychological conditions such as depression and fatigue.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Continuous activity data regarding sleep and physical exercise (amount of exercise, exercise time, exercise duration, intensity of exercise, exercise patterns, diurnal cycles, weekly cycles, regularity or irregularity of exercise, sleep duration, sleep-onset time, sleep latency, and sleep depth) will be collected and assessed for correlations with secondary physical and psychological assessment criteria below. For the cardiac rehabilitation group and groups of those who score high on stress check, changes will be assessed at two weeks following the intervention. In the obese outpatient group, changes will be assessed at six months following the intervention.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Behavior,custom
Interventions/Control_1	The obese outpatient group will wear the activity trackers, and the resulting data will be examined alongside psychological indices. In addition, during the 6 months of data collection, patients will receive counseling once per month.
Interventions/Control_2	The cardiac rehabilitation group will wear the activity trackers for two weeks, and the resulting data will be compared with psychological indices, etc. The group of those who score high on stress check will wear the activity trackers for two weeks, and the resulting data will be compared with psychological indices, etc.
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.Must be at least 20 years old independent at the time of consent. 2.Obese outpatients receiving counseling for lifestyle-related diseases at the above health science center; outpatients receiving cardiac rehabilitation; and thosse who have received high stress scores based upon the Ministry of Health, Labour, and Welfare stress examination conducted at their workplace or elsewhere. 3.Those able to understand the content of the device/test of this study and operate the technology involved in the study. 4.Those who have provided written, informed consent to participate in the study upon full understanding after adequate explanation of the study has been provided.
Key exclusion criteria	1.Those finding self-directed physical activity to be difficult. 2.Those taking antidepressant or antipsychotic drugs, or those suffering from cranial nerve disorders. 3.Those judged unsuitable for participation in the study based upon psychiatric disorders. 4.Those suffering from diabetes mellitus or hypertension with inadequately controlled disease. 5.Those with allergic reactions to the rubber in the wristband. 6.Those judged by investigators to be unsuitable for study participation for reasons other than the above.
Target sample size	100

Research contact person
Name of lead principal investigator	Yutaka Kimura
Organization	Kansai Medical University
Division name	Health Science
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	Nagisa Hidaka
Organization	1)Osaka Sangyo University, 2)Kansai Medical University
Division name	1)Faculty of International Studies, 2)Health Science
Address	1)3-1-1 Nakagaito, Daito City, Osaka Japan. 2)2-5-1 Shin-machi, Hirakata City, Osaka Japan
TEL	(1)072-875-3001(2)072-804-0101
Homepage URL
Email	hidaka@int.osaka-sandai.ac.jp

Sponsor
Institute	Kansai Medical University Hospital
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)	Research grant from the Meiji Yasuda Life Foundation of Health and Welfare

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 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 10 Month 25 Day
Anticipated trial start date	2017 Year 10 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.my-zaidan.or.jp/josei/publications/doc/R33_08.pdf
Results
Other related information

Management information
Registered date	2017 Year 10 Month 25 Day
Last modified on	2019 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031167