UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046937 |
|---|---|
| Receipt number | R000053551 |
| Scientific Title | Relationship between fasting and decreased swallowing function in patients with gastrointestinal diseases: a non-randomized controlled trial. |
| Date of disclosure of the study information | 2022/03/20 |
| Last modified on | 2022/07/12 12:17:04 |
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Basic information
Public title
Relationship between fasting and decreased swallowing function in patients with gastrointestinal diseases: a non-randomized controlled trial.
Acronym
Relationship between fasting and decreased swallowing function in patients with gastrointestinal diseases: a non-randomized controlled trial.
Scientific Title
Relationship between fasting and decreased swallowing function in patients with gastrointestinal diseases: a non-randomized controlled trial.
Scientific Title:Acronym
Relationship between fasting and decreased swallowing function in patients with gastrointestinal diseases: a non-randomized controlled trial.
Region
| Japan |
Condition
Condition
gastrointestinal diseases
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether swallowing exercise can maintain swallowing function that is found to be decreased by fasting during treatment of gastrointestinal diseases.
Basic objectives2
Others
Basic objectives -Others
Nothing
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating and swallowing function
Key secondary outcomes
Oral hygiene, BMI and calf circumference
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
10 minute swallowing exercise (3 times/day, about one week)
Interventions/Control_2
No swallowing exercise
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
(1)Patients admitted to the Gastroenterological Surgery Ward/IUHW Shioya Hospital
(2) Fasting period of approximately one week (5 to 9 days)
(3) Patients who are able to provide verbal and written consent to participate in the study of their own free will
Key exclusion criteria
(1) In the case of a subject who appears to be incapable of giving informed consent.
(2) When it is difficult to evaluate the appropriate feeding and swallowing function due to higher brain dysfunction such as oral-facial apraxia.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kurachi |
Organization
International University of Health and Welfare
Division name
Speech and Hearing Sciences
Zip code
286-8686
Address
4-3 Kozunomori, Narita city, Chiba
TEL
0476-20-7726
mkurachi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Shimada |
Organization
International University of Health and Welfare Shioya Hospital
Division name
Rehabilitation
Zip code
329-2145
Address
77 Tomita, Yaita city, Tochigi
TEL
0287-44-1155
Homepage URL
shimada-shioya@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare
Address
77 Tomita, Yaita city, Tochigi
Tel
0287441155
shimada-shioya@iuhw.ac.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
| 2022 | Year | 03 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 17 | Day |
Last modified on
| 2022 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053551
