UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063027 |
|---|---|
| Receipt number | R000072149 |
| Scientific Title | Human Movement as a Digital Vital Sign: A Standardized Framework for Video-Based Artificial Intelligence Motion Analysis |
| Date of disclosure of the study information | 2026/09/23 |
| Last modified on | 2026/09/23 12:26:43 |
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Basic information
Public title
Video-based AI motion analysis of physical function in patients with cardiovascular disease
Acronym
AI-MOVE study
Scientific Title
Human Movement as a Digital Vital Sign: A Standardized Framework for Video-Based Artificial Intelligence Motion Analysis
Scientific Title:Acronym
AI-MOVE (AI MOtion analysis as a Vital sign Evaluation) study
Region
| Japan |
Condition
Condition
Cardiovascular disease requiring hospitalization, including heart failure, ischemic heart disease, valvular heart disease, arrhythmia, pulmonary hypertension, and peripheral artery disease
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of video-based artificial intelligence motion analysis during Short Physical Performance Battery (SPPB) testing performed as part of routine inpatient care in patients hospitalized for cardiovascular disease, and to explore associations between video-derived motion features and conventional physical performance measures, frailty, activities of daily living, musculoskeletal conditions, and post-discharge outcomes, in order to establish human movement as a quantitative digital vital sign.
Basic objectives2
Others
Basic objectives -Others
Feasibility of video-based AI motion analysis and exploration of its associations with physical function and clinical outcomes
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of enrolled patients with analyzable video data at the first SPPB assessment during hospitalization, calculated for each SPPB component (standing balance, 4-m gait, and repeated chair stands). A video is defined as analyzable when the required key points are detected throughout the task and the whole body remains in view. The prespecified target is at least 80% for each component.
Key secondary outcomes
1. Completion rate of video-recorded SPPB tasks and reasons for unanalyzable videos (at the first assessment during hospitalization)
2. Distribution of video-derived motion features (at the first assessment during hospitalization)
3. Associations between video-derived motion features and SPPB score, gait speed, frailty, activities of daily living, musculoskeletal conditions, and clinical characteristics
4. Comparison of information obtained from frontal and lateral views, to define the minimum requirements for future single-view acquisition
5. In a subset of at least 30 patients, agreement between video-derived gait speed and chair-stand time and stopwatch-measured values (intraclass correlation coefficient, Bland-Altman analysis), and reproducibility on repeated analysis of the same videos by independent analysts
6. Exploratory associations between video-derived motion features and outcomes at 6 and 12 months and up to 5 years after discharge (decline in activities of daily living, new or worsened care-needs certification, falls, institutionalization, rehospitalization, cardiovascular events, all-cause death)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Aged 20 years or older
2. Hospitalized at Kumamoto University Hospital for cardiovascular disease (heart failure, ischemic heart disease, valvular heart disease, arrhythmia, pulmonary hypertension, peripheral artery disease, etc.) or undergoing inpatient cardiac rehabilitation
3. Scheduled to undergo the Short Physical Performance Battery (SPPB) or part of it during hospitalization or before discharge
4. Able to perform at least one video-recordable physical performance task
5. Able to provide written informed consent
Key exclusion criteria
1. Aged under 20 years
2. Active malignancy, severe infection, or severe trauma
3. Physical performance testing considered unsafe because of hemodynamic instability, severe respiratory compromise, acute neurological deterioration, or other unstable medical conditions
4. Unable to perform any of the 3 SPPB components because of severe physical disability
5. Severe cognitive impairment or communication difficulty precluding understanding of the study procedures
6. Participation judged inappropriate by the attending physician or the investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Matsuzawa |
Organization
Kumamoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL
096-373-5175
matsuzawa-y@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Matsuzawa |
Organization
Kumamoto University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
860-8556
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
TEL
096-373-5175
Homepage URL
matsuzawa-y@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Yasushi Matsuzawa
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
Kumamoto University IRB
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan
Tel
096-373-5657
iyks-iji@jimu.kumamoto-u.ac.jp
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
熊本大学病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2035 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2035 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2035 | Year | 03 | Month | 31 | Day |
Other
Other related information
This registration covers the artificial intelligence motion analysis component of a prospective cohort study of patients hospitalized for cardiovascular disease (Kumamoto University, Approval No. 3338). The primary endpoint of the overall cohort is a composite of cardiovascular events or all-cause death during follow-up of up to 5 years.
Management information
Registered date
| 2026 | Year | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072149
