UMIN-ICDS Clinical Trial

Public title

Longitudinal Changes and Associated Factors of Functioning and Health-Related Quality of Life in Community-Dwelling Individuals: From the perspective of meaningful activities

Acronym

MAC-LOS (Meaningful Activities and Community-dwelling Longitudinal Study)

Scientific Title

Longitudinal Changes and Associated Factors of Functioning and Health-Related Quality of Life in Community-Dwelling Individuals: From the perspective of occupational performance

Scientific Title:Acronym

OP-CLO (Occupational Performance and Community-dwelling Longitudinal Study)

Region

Japan

Condition

Community-dwelling residents

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To longitudinally investigate the changes over time in health-related quality of life (HRQOL) and evaluate its associations with modifiable factors, including functioning, physical activity levels, and psychological status.

Basic objectives2

Others

Basic objectives -Others

As described in Purpose 1

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Health-related quality of life scores measured by the EQ-5D-5L (assessed annually from baseline up to 4 years)

Key secondary outcomes

1. Occupational performance scores assessed by the Self-completed Occupational Performance Index (SOPI).
2. Moderate-to-vigorous physical activity levels measured by the Brief Physical Activity Questionnaire (BOPAQ).
3. Psychological distress scores screened by the Kessler Psychological Distress Scale (K6).
4. Mini-Cog
5. Subjective life satisfaction scores evaluated by the Satisfaction with Life Scale (SWLS).
6. Presence, duration, intensity of pain, and the number of chronic pain sites.
(All variables will be assessed annually from baseline up to 3 years; total of 4 times).

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

18

years-old

<=

Age-upper limit

120

years-old

>=

Gender

Male and Female

Key inclusion criteria

Individuals who meet all of the following criteria:
1. Actively participating in social interactions or activities at a community-based gathering place ("Kayoi-no-ba") (excluding individuals who require hospitalization or advanced medical management).
2. Independent in ambulation (either unassisted or independent with the use of an assistive walking device).
3. Capable of understanding the study details, responding to questionnaires, and wearing assessment devices (excluding individuals with a formal physician diagnosis of dementia).
4. Capable of participating in all four annual evaluations.

Key exclusion criteria

Individuals with a formal physician diagnosis of dementia

Target sample size

300

Name of lead principal investigator

1st name	Yoichi
Middle name
Last name	Tanaka

Organization

Hyogo Medical University

Division name

Department of Occupational Therapy, Faculty of Rehabilitation

Zip code

650-8530

Address

1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo

TEL

078-304-3180

Email

yi-tanaka@hyo-med.ac.jp

Name of contact person

1st name	Same as above
Middle name
Last name	Same as above

Organization

Same as above

Division name

Same as above

Zip code

Same as above

Address

Same as above

TEL

078-304-3180

Homepage URL

Email

yi-tanaka@hyo-med.ac.jp

Institute

Hyogo Medical University

Institute

Department

Personal name

Organization

Hyogo Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Academic institution

Co-sponsor

Name of secondary funder(s)

Organization

Hyogo Medical University

Address

1-3-6 Minatojima, Chuo-ku, Kobe, Hyogo

Tel

078-304-3180

Email

yi-tanaka@hyo-med.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

2026

Year

07

Month

27

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

08

Month

31

Day

Date of IRB

Anticipated trial start date

2026

Year

09

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

This study will be conducted with the approval of the Research Ethics Committee of Hyogo University of Medicine (Approval No.: 202606-309). The findings of this study are planned to be widely disseminated through presentations at domestic and international conferences and publications in peer-reviewed scientific journals.

Registered date

2026

Year

07

Month

27

Day

Last modified on

2026

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071356