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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024597
Receipt No. 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

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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
Institute Gunma Prefectural College of Health Science
Institute
Department

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
URL(English) https://upload.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


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