UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053222 |
|---|---|
| Receipt number | R000060479 |
| Scientific Title | Oral frailty as a risk factor for malnutrition, sarcopenia and physical frailty in dialysis patients |
| Date of disclosure of the study information | 2023/12/26 |
| Last modified on | 2025/01/06 11:27:16 |
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Basic information
Public title
Oral frailty as a risk factor for malnutrition, sarcopenia and physical frailty in dialysis patients
Acronym
Oral frailty as a risk factor for malnutrition, sarcopenia and physical frailty in dialysis patients
Scientific Title
Oral frailty as a risk factor for malnutrition, sarcopenia and physical frailty in dialysis patients
Scientific Title:Acronym
Oral frailty as a risk factor for malnutrition, sarcopenia and physical frailty in dialysis patients
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between oral frailty and malnutrition, sarcopenia, and physical frailty in dialysis patients.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between oral frailty and the rate of change in dry weight (BMI) in dialysis patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of change in physical frailty evaluation index (revised Japanese version CHS standards) score after 1 year for each patient stratified by oral frailty self-check score
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Persons who are 20 years of age or older at the time of obtaining consent
Persons who have received sufficient explanation and have given written informed consent of their own free will to participate in this research with full understanding
Persons with both upper and lower limbs
Persons who can maintain a standing position
Key exclusion criteria
Persons who have requested refusal to participate in this research
Persons judged by the research director to be unsuitable as research subjects
Persons with defects in either upper or lower limbs
Persons who cannot maintain standing position
Persons using implanted medical devices such as cardiac pacemakers
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Abe |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchikamimachi, Itabashiku, Tokyo
TEL
0339728111
abe.masanori@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Miyasato |
Organization
Nihon University School of Medicine
Division name
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine
Zip code
173-8610
Address
30-1, Oyaguchikamimachi, Itabashiku, Tokyo
TEL
0339728111
Homepage URL
kmiyasato123@gmail.com
Sponsor or person
Institute
Nihon University
Institute
Department
Personal name
Kota Miyasato
Funding Source
Organization
Nihon 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
Nihon University School of Medicine
Address
30-1, Oyaguchikamimachi, Itabashiku, Tokyo
Tel
0339728111
med.rinsyokenkyu@nihon-u.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
| 2023 | Year | 12 | Month | 26 | 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
200
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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Dialysis patients at our facility who met the inclusion criteria between December 26, 2023 and March 31, 2027
Management information
Registered date
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060479
