UMIN-ICDS Clinical Trial

Public title

Research on the physical abilities, activity patterns, and mental and physical health of the elderly using wearable devices

Acronym

Research on the physical abilities, activity patterns, and mental and physical health of the elderly using wearable devices

Scientific Title

Research on the physical abilities, activity patterns, and mental and physical health of the elderly using wearable devices

Scientific Title:Acronym

Research on the physical abilities, activity patterns, and mental and physical health of the elderly using wearable devices

Region

Japan

Condition

apathy, locomotive syndrome

Classification by specialty

Psychiatry	Orthopedics	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to repeatedly measure physical activity over one year in elderly residents to explore its association with apathy and to find physical activities and exercise methods useful for the prevention of apathy.

Basic objectives2

Others

Basic objectives -Others

The objective is to develop a method for classifying subtypes of locomotive syndrome based on muscle strength, balance ability, and physical activity patterns, as well as to propose appropriate exercise guidance techniques for patients of each subtype.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

The real-time measurement of the types of activities, energy expenditure, heart rate, motion, sleep, and the number of steps from wearable devices during the tracking period of one month each in spring, summer, autumn, and winter.

Key secondary outcomes

Indicators measured at baseline
01. Locomo 25 Questionnaire
02. The Japanese version of the Dimensional Apathy Scale (J-DAS)
03. The Japanese version of the Geriatric Depression Scale 15 (GDS)
04. The Japanese version of the Mini-Mental State Examination (MMSE-J)
05. Structured Clinical Interview for DSM-IV (SCID)
06. Starkstein
07. Demographic characteristics, educational background, work history
08. Current illnesses, medications taken, medical history (treatment status, hospitalizations, clinic visits), presence of falls
09. Body composition, grip strength, time standing on one foot with eyes open, stride length, arch of the foot, stand-up test, 2-step test, 10m walking speed
10. Pegboard test

Indicators Measured During the One-Month Tracking Period in Spring, Summer, Autumn, and Winter:
01. J-DAS
02. GDS
03. Physical Activity Survey
04. Real-time measurement with wearable devices (presence of conversation, ultraviolet, body surface temperature, three-axis acceleration, peak-to-peak interval)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

65

years-old

<=

Age-upper limit

122

years-old

>

Gender

Male and Female

Key inclusion criteria

Elderly residents aged 70 and over, living in the Aomori Prefecture community in Japan, who are willing to participate in the study

Key exclusion criteria

01. Individuals with a nursing care requirement level of 1 or higher
02. Individuals diagnosed with depression or dementia by a physician
03. Individuals with alcohol dependence or mental illness, deemed by a physician as having difficulty participating in the survey
04. Individuals with unstable treatment conditions or undergoing treatment for life-threatening diseases
05. Individuals receiving treatment for diseases that limit physical activity, such as rheumatism or stroke
06. Individuals already participating in other intervention trials

Target sample size

220

Name of lead principal investigator

1st name	Yichi
Middle name
Last name	Yang

Organization

Hirosaki University

Division name

Department of Social Medicine, Graduate School of Medicine

Zip code

036-8562

Address

5 Zaifu-cho Hirosaki city, Aomori Prefecture, Japan

TEL

+81-172-39-5041

Email

soc-med@hirosaki-u.ac.jp

Name of contact person

1st name	Yichi
Middle name
Last name	Yang

Organization

Hirosaki University

Division name

Department of Social Medicine, Graduate School of Medicine

Zip code

036-8562

Address

5 Zaifu-cho Hirosaki city, Aomori Prefecture, Japan

TEL

+81-172-39-5478

Homepage URL

Email

yangy@hirosaki-u.ac.jp

Institute

Hirosaki University

Institute

Department

Personal name

Yichi Yang

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hirosaki University Graduate School of Medicine Ethics Committee

Address

5 Zaifu-cho Hirosaki city, Aomori Prefecture, Japan

Tel

+81-172-39-5044

Email

rinri@hirosaki-u.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

弘前大学医学研究科社会医学講座

Date of disclosure of the study information

2023

Year

12

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2023

Year

07

Month

05

Day

Date of IRB

2023

Year

07

Month

18

Day

Anticipated trial start date

2023

Year

09

Month

08

Day

Last follow-up date

2024

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design
Prospective cohort study

Participant recruitment
Request Hirosaki City Hall to distribute flyers for participant recruitment and to place an announcement in the Kouhou Hirosaki, a monthly journal introducing events in Hirosaki city. Notify the members of the Hirosaki University Shiragiku-kai, an association of body donation volunteers, of the recruitment of participants. The recruitment period is from August to December 2023.

Measurements
Indicators measured at baseline
01. Locomo 25 Questionnaire
02. The Japanese version of the Dimensional Apathy Scale (J-DAS)
03. The Japanese version of the Geriatric Depression Scale 15 (GDS)
04. The Japanese version of the Mini-Mental State Examination (MMSE-J)
05. Structured Clinical Interview for DSM-IV (SCID)
06. Starkstein
07. Demographic characteristics, educational background, work history
08. Current illnesses, medications taken, medical history (treatment status, hospitalizations, clinic visits), presence of falls
09. Body composition, grip strength, time standing on one foot with eyes open, stride length, arch of the foot, stand-up test, 2-step test, 10m walking speed
10. Pegboard test
Indicators Measured During the One-Month Tracking Period in Spring, Summer, Autumn, and Winter:
01. J-DAS
02. GDS
03. Physical Activity Survey
04. Real-time measurement with wearable devices (the types of activities, energy expenditure, heart rate, motion, sleep, the number of steps, presence of conversation, ultraviolet, body surface temperature, three-axis acceleration, peak-to-peak interval)

Registered date

2023

Year

12

Month

12

Day

Last modified on

2023

Year

12

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060530