UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029699 |
|---|---|
| Receipt number | 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 16:59:20 |
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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
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
hidaka@int.osaka-sandai.ac.jp
Sponsor or person
Institute
Kansai Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031167
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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