UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000029699|
|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|
|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|
|Condition||Obese outpatients, cardiac rehabilitation patients, and those who score high on stress check|
|Classification by specialty||
|Classification by malignancy||Others|
|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 objectives -Others|
|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|
|Blinding||Open -no one is blinded|
|No. of arms||2|
|Purpose of intervention||Treatment|
|Type of intervention||
|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.
|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||
|Organization||Kansai Medical University|
|Division name||Health Science|
|Address||2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan|
|Name of contact person||
|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|
|Institute||Kansai Medical University Hospital|
|Category of Funding Organization||Self funding|
|Nationality of Funding Organization|
|Other related organizations|
|Name of secondary funder(s)||Research grant from the Meiji Yasuda Life Foundation of Health and Welfare|
|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Published|
|URL related to results and publications||https://www.my-zaidan.or.jp/josei/publications/doc/R33_08.pdf|
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|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB|
|Anticipated trial start date||
|Last follow-up date|
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|Date analysis concluded|
|Other related information|
|Last modified on||
|Link to view the page|
|Registered date||File name|
|Research case data specifications|
|Registered date||File name|
|Research case data|
|Registered date||File name|