UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052436 |
|---|---|
| Receipt number | R000038240 |
| Scientific Title | Early diagnosis of sarcopenia in medical disorders ~Examination of usefulness of biometric data~ |
| Date of disclosure of the study information | 2023/10/07 |
| Last modified on | 2023/10/07 11:30:05 |
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Basic information
Public title
Early diagnosis of sarcopenia in medical disorders
~Examination of usefulness of biometric data~
Acronym
Early diagnosis of sarcopenia in medical disorders
~Examination of usefulness of biometric data~
Scientific Title
Early diagnosis of sarcopenia in medical disorders
~Examination of usefulness of biometric data~
Scientific Title:Acronym
Early diagnosis of sarcopenia in medical disorders
~Examination of usefulness of biometric data~
Region
| Japan |
Condition
Condition
Neurodegenerative diseases including Parkinson's disease, Parkinson's syndrome, progressive supranuclear palsy.
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establish a diagnostic method for Sarcopenia that can be carried out even by individuals by examining the correlation between the amount of activity measured by the biometric device and the muscle mass using the medical body composition meter and the grip strength and the walking speed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of activity during sleeping by the biometric device and the degree of agreement between the estimation of sarcopenia and actual occurrence.
Key secondary outcomes
Existence of frail, correlation between muscle mass and activity level.
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Before going to bed, the examinee measures muscle mass using a medical body composition meter.
Interventions/Control_2
Attach a biometric measurement device (contact type sensor). Wearing is carried out under the guidance of the experimenter or the experiment collaborator.
The non-contact sensor is operated only overnight (bedtime).
The examinee removes the biometric measuring device at the time of getting up. Removal is performed under the guidance of the experimenter or the experiment collaborator.
A limb wearing type activity meter mounts a band type activity meter (accelerometer) on the left and right wrists, the left and right ankles, or both.
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
Patient group
1.Age: patients aged 20 years or older at the time of acquisition
2.Gender: No prejudice
3.Patients with outpatient visit with neurodegenerative diseases including Parkinson's disease
4.Patients who gained written consent from patients' free will after having sufficient explanation for their participation in this research, with sufficient understanding. Especially when consignment is necessary, decide after consultation.
Control group
1.Age: Subjects aged 20 years or older at the time of consent acquisition
2.Gender: No prejudice
3.After receiving sufficient explanation for participation in this research, after having sufficient understanding, the examinees who obtained document consent by their subjects' free will
Key exclusion criteria
1.Pregnant women and subjects who may be pregnant, or who are breastfeeding
2.Patients who are difficult to stay at general accommodations (hotels, inns, etc.)
3.In addition, subjects whose research managers judged inappropriate as research subjects
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Yamamura |
Organization
University of Fukui
Division name
Regional Medicine Promotion Course, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuoka-Shimogetsu Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8264
t-toku@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Yamamura |
Organization
University of Fukui
Division name
Regional Medicine Promotion Course, Faculty of Medical Sciences
Zip code
910-1193
Address
23-3 Matsuoka-Shimogetsu Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-8264
Homepage URL
t-toku@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Self Funding
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
University of Fukui
Address
23-3 Matsuoka-Shimogetsu Eiheiji-cho, Yoshida-gun, Fukui
Tel
0776-61-8264
t-toku@u-fukui.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 | 10 | Month | 07 | 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
90
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2023 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038240
