UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059053 |
|---|---|
| Receipt number | R000067547 |
| Scientific Title | Research on the relationship between physical function, malnutrition, and swallowing function |
| Date of disclosure of the study information | 2025/09/11 |
| Last modified on | 2025/09/10 20:37:15 |
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Basic information
Public title
Research on the relationship between physical function, malnutrition, and swallowing function
Acronym
Research on the relationship between physical function, malnutrition, and swallowing function
Scientific Title
Research on the relationship between physical function, malnutrition, and swallowing function
Scientific Title:Acronym
Research on the relationship between physical function, malnutrition, and swallowing function
Region
| Japan |
Condition
Condition
Frail elderly subjects
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between physical function and physical activity and feeding and swallowing function in order to prevent aspiration pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body measurements and body composition are assessed using weight, body mass index (BMI), body fat percentage, body fat mass, skeletal muscle mass, upper arm circumference, triceps skinfold thickness, upper arm muscle area, lower leg circumference, and neck circumference.
Physical function is assessed using grip strength, maximum walking speed, quadriceps endurance, lower limb muscle strength, respiratory muscle function, and Functional Independence Measure (FIM).
Nutritional status is assessed using the MUST, NRS-2002, MNA-SF, CONUT, and GLIM criteria.
Feeding and swallowing function, and oral condition are assessed using the Repetitive Saliva Swallowing Test, Modified Water Swallowing Test, tongue pressure strength, and oral dryness.
Key secondary outcomes
Cognitive function will be assessed using the MMSE.
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
| Other |
Interventions/Control_1
Evaluate based on items related to physical function, malnutrition status, and swallowing function.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hospitalized patients aged 65 and over
Key exclusion criteria
A. Individuals requiring treatment such as enteral nutrition or parenteral nutrition
B. Individuals with severe dysphagia unable to ingest orally
C. Individuals with a Japan Coma Scale (JCS) level of II-2 or higher
D. Individuals experiencing frequent episodes of poor health
E. Individuals within 12 months of cerebrovascular disease onset
F. Individuals unable to understand the study explanation (however, they may be included if consent is obtained from a proxy; if the participant shows signs or actions indicating refusal, their
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, nara-shi, nara-ken
TEL
0742414742
sa-abe@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Faculty of Contemporary Life Studies, Department of Food and Nutrition
Zip code
631-8585
Address
Gakuenminami 3-1-3, nara-shi, nara-ken
TEL
0742414742
Homepage URL
sa-abe@tezukayama-u.ac.jp
Sponsor or person
Institute
Tezukayama University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tezukayama University
Address
Gakuenminami 3-1-3, nara-shi, nara-ken
Tel
0742414742
sa-abe@tezukayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-05
Org. issuing International ID_1
Tezukayama University Research Ethics Committee
Study ID_2
124
Org. issuing International ID_2
Takai Hospital Ethics Committee
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2025 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067547
