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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023779
Receipt No. R000027393
Scientific Title The effect of tongue exercise on nutritional status in hemodialysis patients
Date of disclosure of the study information 2016/09/12
Last modified on 2017/10/17

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Basic information
Public title The effect of tongue exercise on nutritional status in hemodialysis patients
Acronym The effect of tongue exercise on nutritional status in hemodialysis patients
Scientific Title The effect of tongue exercise on nutritional status in hemodialysis patients
Scientific Title:Acronym The effect of tongue exercise on nutritional status in hemodialysis patients
Region
Japan

Condition
Condition End stage kidney disease requiring hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of tongue exercise nutritional status in hemodialysis patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Serum Albumin
Key secondary outcomes 1) Body weight
2) Dietary intake
3) Tongue pressure
4) Grip strength
5) Simplified Nutritional Appetite Questionnaire score

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
Behavior,custom
Interventions/Control_1 Tongue exercise for two months
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 Outpatients with hemodialysis
Serum albumin under 3.8g/dl
Informed consent
Key exclusion criteria Disagreement
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kitabayashi Kou
Organization Shinkohkai Murakamikinen Hospital
Division name Nutrition
Zip code
Address 204-1 Matuyama, Murakami-shi, Niigata 958-0034, Japan
TEL 0254-52-1229
Email kinen.eiyo@shinkohkai.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kitabayashi Kou
Organization Shinkohkai Murakamikinen Hospital
Division name Nutrition
Zip code
Address 204-1 Matuyama, Murakami-shi, Niigata 958-0034, Japan
TEL 0254-52-1229
Homepage URL
Email whm13002@nuhw.ac.jp

Sponsor
Institute Shinkohkai Murakamikinen Hospital
Department of Nutrition
Institute
Department

Funding Source
Organization The Japanese Society for Dialysis Therapy
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 新光会村上記念病院(新潟県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://doi.org/10.4009/jsdt.50.547
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
2016 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nihon Toseki Igakkai Zasshi
Vol. 50 (2017) No. 9 p. 547-553

https://www.jstage.jst.go.jp/article/jsdt/50/9/50_547/_article/-char/ja

Management information
Registered date
2016 Year 08 Month 26 Day
Last modified on
2017 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027393

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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