UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060758 |
|---|---|
| Receipt number | R000068032 |
| Scientific Title | Longitudinal registry study on functional status, activity, and quality of life among day rehabilitation users: evaluation of effects through mediation analysis, MCID estimation, and profile classification |
| Date of disclosure of the study information | 2026/03/01 |
| Last modified on | 2026/02/26 16:07:47 |
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Basic information
Public title
Prospective Cohort Study of Functional Gains, Life-Space Mobility, and Quality of Life in Day Rehabilitation
Acronym
DAY-LIFE Study
Scientific Title
Longitudinal registry study on functional status, activity, and quality of life among day rehabilitation users: evaluation of effects through mediation analysis, MCID estimation, and profile classification
Scientific Title:Acronym
DAY-LIFE-Registry
Region
| Japan |
Condition
Condition
Community-dwelling older adults attending day rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether functional gains during day rehabilitation translate into improved life-space mobility and health-related quality of life, and to explore whether fall status and service utilization modify these associations.
Basic objectives2
Others
Basic objectives -Others
This study aims to longitudinally examine changes in functional status, activity, and quality of life among community-dwelling older adults attending day rehabilitation services. Specifically, it investigates the mediation pathway through which functional improvements contribute to better life-space mobility and consequently to enhanced health-related quality of life (HRQoL) and instrumental activities of daily living (IADL). In addition, the study estimates the minimal clinically important difference (MCID) using patient-perceived improvement as an anchor and identifies functional activity profiles associated with clinical outcomes. The ultimate goal is to provide evidence for the measurable impact of day rehabilitation, facilitating data-driven quality improvement in clinical practice and service management.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Life-Space Assessment, EQ-5D-5L
Key secondary outcomes
Timed Up & Go test (TUG), Five Times Sit-to-Stand Test (FTSST), Grip force, Lawton IADL, Global Rating of Change (GRC), Fall history
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Individuals who are newly enrolled in or currently attending the day rehabilitation program at our institution.
2. Community-dwelling older adults aged 65 years or older.
3. Participants who provide written informed consent after being informed of the study details.
Key exclusion criteria
1. Individuals with cognitive or severe physical conditions that make participation in assessments or questionnaire surveys substantially difficult.
2. Individuals deemed unsuitable for participation by their attending physician.
3. Loss to follow-up events such as death, long-term hospitalization, or relocation will be handled as censoring in the analysis rather than as exclusion at baseline.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Kitaji |
Organization
Tokyo General Hospital
Division name
Department of Rehabilitation
Zip code
1658906
Address
Egota 3-15-2, Nakano-ku, Tokyo
TEL
03-3387-5421
Yu.kitaji@mt.strins.or.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kitaji |
Organization
Tokyo General Hospital
Division name
Department of Rehabilitation
Zip code
1658906
Address
Egota 3-15-2, Nakano-ku, Tokyo
TEL
03-3387-5421
Homepage URL
yu.kitaji@mt.strins.or.jp
Sponsor or person
Institute
Tokyo General Hospital
Institute
Department
Personal name
Yu Kitaji
Funding Source
Organization
None
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
Tokyo General Hospital
Address
Egota 3-15-2, Nakano-ku, Tokyo
Tel
03-3387-5421
https://www.tokyo-hospital.com/
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
| 2026 | Year | 03 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068032
