UMIN-ICDS Clinical Trial

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

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

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

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.

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

t-toku@u-fukui.ac.jp

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

Email

t-toku@u-fukui.ac.jp

Institute

University of Fukui

Institute

Department

Personal name

Organization

Self Funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

University of Fukui

Address

23-3 Matsuoka-Shimogetsu Eiheiji-cho, Yoshida-gun, Fukui

Tel

0776-61-8264

Email

t-toku@u-fukui.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

10

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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/icdr_e/ctr_view.cgi?recptno=R000038240