UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029634 |
|---|---|
| Receipt number | R000030957 |
| Scientific Title | The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease |
| Date of disclosure of the study information | 2017/10/20 |
| Last modified on | 2021/10/29 19:03:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Acronym
The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Scientific Title
The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Scientific Title:Acronym
The relationships between longitudinal physical activity and psychological indices of the patient with lifestyle-related disease
Region
| Japan |
Condition
Condition
1. metabolic syndrome
2. obesity,
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Studying the connection between data on continuous bodily activity (including sleep) measured using a wristband-type physical activity meter and psychological indices related to depression and fatigue, and then studying whether psychological states related to depression and fatigue are analogous based on physical activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Diet and exercise counseling given once monthly for six months while wearing physical activity meter
Interventions/Control_2
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.Independent person 20 years or older at time of consent
2.Is receiving lifestyle disease counseling at health sciences center
3.Understands the tools, tests and other elements of this study, and is capable of using and implementing them
4.Has received a full explanation of participation in this study and given their written consent of their own accord
Key exclusion 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Kimura |
Organization
Kansai Medical University
Division name
Health Science
Zip code
573-1010
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 | Nagisa |
| Middle name | |
| Last name | Hidaka |
Organization
1)Osaka Sangyo University, 2)Kansai Medical University
Division name
1)Faculty of International Studies, 2)Health Science
Zip code
574-8530
Address
1)3-1-1 Nakagaito, Daito City, Osaka 574-853,2)2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 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
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)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
2-5-1 Shin-machi, Hirakata City, Osaka 573-1010 Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.ac.jp
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 | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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 | 20 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 20 | Day |
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 | 20 | Day |
Last modified on
| 2021 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030957
