UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023779 |
|---|---|
| Receipt number | 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 08:13:37 |
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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
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
whm13002@nuhw.ac.jp
Sponsor or person
Institute
Shinkohkai Murakamikinen Hospital
Department of Nutrition
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027393
