UMIN-ICDS Clinical Trial

Public title

A study of the effects of generative AI-assisted reflection on daily habits on health and functional capacity in older adults

Acronym

AI-LIFE Study

Scientific Title

An interventional study of generative AI-assisted lifestyle reflection support for maintaining functional capacity in older adults

Scientific Title:Acronym

AI-LIFE Study

Region

Japan

Condition

Prevention of age-related decline in functional capacity and frailty in older adults

Classification by specialty

Geriatrics	Nursing	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effects and feasibility of a 3-month generative AI-assisted lifestyle reflection intervention on the maintenance of functional capacity and health-related behaviors in older adults, with a focus on enhancing self-awareness and self-efficacy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in the total score of the Kihon Checklist from baseline to 3 months after initiation of the intervention.

Key secondary outcomes

Self-efficacy, self-esteem, physical activity (IPAQ-SF), physical function, sleep (AIS and sleep sensor data), fear of falling (FES-I), cognitive function, bone density, AI use, adverse events, and evaluation of the final interview. Assessments are conducted at baseline, approximately 1.5 months, and 3 months.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Participants receive a 3-month generative AI-assisted conversational intervention to support reflection on daily lifestyle. The AI supports reflection on physical activity, sleep, physical condition, mood, diet, and outings; helps participants verbalize reasons for successful or unsuccessful behaviors; reviews personal goals; and provides general information on health maintenance and fall prevention. Health assessments and feedback are provided at baseline, approximately 1.5 months, and 3 months. At the end of the intervention, participants undergo an interview based on a summary of AI conversations and assessment results. The AI does not provide diagnosis, treatment, or medication advice.

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

60

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria
Age 60 years or older.
Able to communicate in Japanese.
Able to use the tablet device installed in the participant's room.
Able and willing to provide written informed consent to participate in the study.

Key exclusion criteria

Exclusion criteria

Individuals who have been advised by their attending physician to restrict physical activity or exercise.
Individuals for whom participation in the study is considered difficult due to severe cognitive impairment or other conditions.
Individuals with severe visual or hearing impairment that makes study assessments or operation of the study tools difficult.
Individuals whom the principal investigator determines to be unsuitable for participation in the study.

Target sample size

30

Name of lead principal investigator

1st name	Miyae
Middle name
Last name	Yamakawa

Organization

The University of Osaka Graduate School of Medicine

Division name

Division of Health Sciences, Graduate School of Medicine

Zip code

5650871

Address

1-7 Yamadaoka, Suita, Osaka

TEL

0668792543

Email

miyatabu@sahs.med.osaka-u.ac.jp

Name of contact person

1st name	Miyae
Middle name
Last name	Yamakawa

Organization

The University of Osaka

Division name

Division of Health Sciences, Graduate School of Medicine

Zip code

5650871

Address

Division of Health Sciences, Graduate School of Medicine

TEL

0668792543

Homepage URL

Email

miyatabu@sahs.med.osaka-u.ac.jp

Institute

The University of Osaka

Institute

Department

Personal name

Miyae Yamakawa

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Review Board of Osaka University Hospital

Address

2-2 Yamadaoka, Suita, Osaka

Tel

06-6879-6106

Email

rinri@hp-crc.med.osaka-u.ac.jp

Secondary IDs

YES

Study ID_1

26183

Org. issuing International ID_1

Ethical Review Board of Osaka University Hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

09

Month

14

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

Preinitiation

Date of protocol fixation

2026

Year

09

Month

09

Day

Date of IRB

Anticipated trial start date

2026

Year

10

Month

01

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 related information

Registered date

2026

Year

09

Month

14

Day

Last modified on

2026

Year

09

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072025