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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029699
Receipt No. R000031167
Scientific Title A study assessing changes in mental state and mood based on continuous longitudinal physical activity, exercise, and sleep habits
Date of disclosure of the study information 2017/10/25
Last modified on 2019/01/10

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Basic information
Public title A study assessing changes in mental state and mood based on continuous longitudinal physical activity, exercise, and sleep habits
Acronym A study assessing changes in mental state and mood based on continuous longitudinal physical activity, exercise, and sleep habits
Scientific Title A study assessing changes in mental state and mood based on continuous longitudinal physical activity, exercise, and sleep habits
Scientific Title:Acronym 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
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 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

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 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.my-zaidan.or.jp/josei/publications/doc/R33_08.pdf
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 25 Day
Date of IRB
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

Other
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

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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