UMIN ID: UMIN000029634
Registered date:20/10/2017
The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | 1. metabolic syndrome 2. obesity, |
| Date of first enrollment | 2017/10/20 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Diet and exercise counseling given once monthly for six months while wearing physical activity meter |
Outcome(s)
| Primary Outcome | 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. |
|---|---|
| Secondary Outcome | 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) |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | Kansai Medical University |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Nagisa Hidaka |
| Address | 1)3-1-1 Nakagaito, Daito City, Osaka 574-853,2)2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan Japan 574-8530 |
| Telephone | (1)072-875-3001-(2)072-804-0101 |
| hidaka@int.osaka-sandai.ac.jp | |
| Affiliation | 1)Osaka Sangyo University, 2)Kansai Medical University 1)Faculty of International Studies, 2)Health Science |
| scientific contact | |
| Name | Yutaka Kimura |
| Address | 2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan Japan |
| Telephone | 072-804-0101 |
| kimuray@hirakata.kmu.ac.jp | |
| Affiliation | Kansai Medical University Health Science |