UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024597
Receipt number R000027766
Scientific Title Recreation of the effect on the constipation of the elderly in Long-Term Care Health Facility
Date of disclosure of the study information 2018/12/01
Last modified on 2019/05/14 09:39:21

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Basic information

Public title

Recreation of the effect on the constipation of the elderly in Long-Term Care Health Facility

Acronym

Recreation of the effect on the constipation of the elderly

Scientific Title

Recreation of the effect on the constipation of the elderly in Long-Term Care Health Facility

Scientific Title:Acronym

Recreation of the effect on the constipation of the elderly

Region

Japan


Condition

Condition

chronic constipation

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Study of the recreation of the effect that was conscious of constipation improvement

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Defecation situation
Intervention before and after

Key secondary outcomes

Taking situation of laxative


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

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

To about 15 minutes exercise a day while singing the song
Laugh along with the laugh bag
To play a game that uses a foot
To the game, such as blowguns use a straw
4 weeks
It does divided into morning and afternoon

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Residents with constipation
They can express their intention

Key exclusion criteria

communication difficulty

Target sample size

15


Research contact person

Name of lead principal investigator

1st name manami
Middle name
Last name kamiyama

Organization

Gunma Prefectural College of Health Science

Division name

School of Science

Zip code

371-0052

Address

323, Kamioki, Maebashi, Gunma

TEL

027-235-1211

Email

manamik@gchs.ac.jp


Public contact

Name of contact person

1st name manami
Middle name
Last name kamiyama

Organization

Gunma Prefectural College of Health Science

Division name

School of Science

Zip code

371-0052

Address

323, Kamioki, Maebashi, Gunma

TEL

027-235-1211

Homepage URL


Email

manamik@gchs.ac.jp


Sponsor or person

Institute

Gunma Prefectural College of Health Science

Institute

Department

Personal name



Funding Source

Organization

Gunma University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma Central Hospital

Address

1-7-13, Koun, Maebashi, Gunma

Tel

027-21-8165

Email

chiken@gunma.jcho.go.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

2018 Year 12 Month 01 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

2016 Year 09 Month 26 Day

Date of IRB


Anticipated trial start date

2016 Year 10 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 27 Day

Last modified on

2019 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027766


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name