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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name