UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035686
Receipt number R000040644
Scientific Title The physical and mental impacts by bathing and exercise at "NAGAYU" kurhaus
Date of disclosure of the study information 2019/01/27
Last modified on 2019/01/26 17:29:39

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Basic information

Public title

The physical and mental impacts by bathing and exercise at "NAGAYU" kurhaus

Acronym

"NAGAYU" kurhaus study

Scientific Title

The physical and mental impacts by bathing and exercise at "NAGAYU" kurhaus

Scientific Title:Acronym

"NAGAYU" kurhaus study

Region

Japan


Condition

Condition

Musculoskeletal pain

Classification by specialty

Medicine in general Psychosomatic Internal Medicine Surgery in general
Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the impacts of bathing and exercise at "Nagayu" kurhaus

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

motor function

Key secondary outcomes

Body measurements, Blood pressure, Subjective health (Visual analogue scale)


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

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

5days bathing and exercise at "Nagayu" kurhaus

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

Who can not exercise and bathing

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuaki Goto

Organization

Japan Health & Research Institute

Division name

Health Tourism Institute

Zip code


Address

3-1-4 Nihonbashi Chuo-ku Tokyo Japan

TEL

+81-3-5390-1625

Email

y_goto422@j-medical-healthcare.com


Public contact

Name of contact person

1st name
Middle name
Last name Yasuaki Goto

Organization

Japan Health & Research Institute

Division name

Health Tourism Institute

Zip code


Address

3-1-4 Nihonbashi Chuo-ku Tokyo Japan

TEL

+81-3-5390-1625

Homepage URL


Email

y_goto422@j-medical-healthcare.com


Sponsor or person

Institute

Japan Health & Research Institute

Institute

Department

Personal name



Funding Source

Organization

Taketa City

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

長湯温泉クアハウス


Other administrative information

Date of disclosure of the study information

2019 Year 01 Month 27 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

Enrolling by invitation

Date of protocol fixation

2018 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2019 Year 01 Month 28 Day

Last follow-up date

2019 Year 02 Month 28 Day

Date of closure to data entry

2019 Year 02 Month 28 Day

Date trial data considered complete

2019 Year 02 Month 28 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 01 Month 27 Day

Last modified on

2019 Year 01 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040644


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name