UMIN-ICDS Clinical Trial

Public title

Comparison of Digital and Manual Physical Fitness Assessment in Older Adults

Acronym

Digital and Manual Fitness Assessment Study

Scientific Title

Observational Comparison of Manual and Digital Methods for Physical Fitness Assessment in Older Adults: Evaluation of Accuracy and Measurement Efficiency

Scientific Title:Acronym

Manual and Digital Physical Fitness Assessment Study

Region

Japan

Condition

Age-related decline in physical function

Classification by specialty

Geriatrics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This analysis aims to compare the time required to administer the Short Physical Performance Battery (SPPB) using digital and manual methods within the same community-dwelling adults aged 60 years or older. It also compares subjective burden through a separate survey of assessors who have used both methods and examines participant experiences. These comparisons assess the operational efficiency and practicality of physical function assessment in community settings.

Basic objectives2

Others

Basic objectives -Others

Comparison of assessment time, assessor burden, and participant experiences in physical function assessment.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Mean within-participant difference in SPPB assessment time (manual minus digital, in seconds).

Times are derived from records timed separately by a designated recorder using a stopwatch, from the start of instructions for the first test to completion of the final test movement. For records containing additional non-SPPB tests, the corresponding test duration and a fixed 15-second instruction allowance are subtracted. The first administration of each method is used for the repeated assessments in the 2026 data. Method-specific averages are used for the two participants with duplicate records in the 2025 data. Recording, report printing, feedback and cleanup after the final movement are outside the timing interval.

Assessment time point: the day each method is administered.

Key secondary outcomes

1. Assessor burden
Among 19 assessors who experienced both methods, compare psychological burden, concern about measurement errors, difficulty judging test start and end points, difficulty with equipment operation and recording, physical burden, post-assessment fatigue, and overall burden. Each item is rated separately on a five-point scale, with higher scores indicating greater burden. Preferred method for future assessments is also recorded.
Assessment time point: after experience with both methods.

2. Participant experience
Questionnaires assess ease of understanding, anxiety and tension, ease of use or task performance, and acceptance of or trust in results. Lower five-point ratings indicate more favorable experiences. Method-choice responses concerning understanding, anxiety, perceived time and satisfaction are reported as proportions. Analyses use questionnaire-specific valid responses for each item and distinguish different constructs and response formats.
Assessment time point: after physical function assessment and before printing and explaining the digital report.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Digital-first sequence.

Participants undergo digital SPPB assessment using AndanteFit (DYPHI), followed by manual SPPB assessment using a stopwatch and recording sheet. In the 2026 assessments, two digital administrations are followed by two manual administrations.

Both methods assess standing balance in three positions, usual-paced 4-m walking, and five chair rises. Assessments take place during the same assessment visit with staff monitoring safety. Rest is provided according to participant condition, without a fixed interval.

Interventions/Control_2

Manual-first sequence.

Participants undergo manual SPPB assessment using a stopwatch and recording sheet, followed by digital SPPB assessment using AndanteFit (DYPHI). In the 2026 assessments, two manual administrations are followed by two digital administrations.

Both methods assess standing balance in three positions, usual-paced 4-m walking, and five chair rises. Assessments take place during the same assessment visit with staff monitoring safety. Rest is provided according to participant condition, without a fixed interval.

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

1. Community-dwelling adults aged 60 years or older attending a community physical fitness assessment event.
2. Able to walk and rise from a chair independently.
3. No marked cognitive impairment and able to understand the study and assessment procedures.
4. Provided written informed consent after receiving an explanation of the study.

These criteria apply to older participants undergoing physical function assessment. The separate assessor-burden survey includes physical therapy students who administered both methods and provided written informed consent.

Key exclusion criteria

1. Major surgery or trauma within the preceding three months.
2. A disease or condition restricting physical activity.
3. Marked walking or balance impairment that prevents completion of the assessments.

Target sample size

150

Name of lead principal investigator

1st name	Sechang
Middle name
Last name	Oh

Organization

R Professional University of Rehabilitation

Division name

Department of Physical Therapy, Faculty of Rehabilitation

Zip code

300-0033

Address

2-10-35 Kohoku, Tsuchiura, Ibaraki 300-0032, Japan

TEL

09066595179

Email

o-sechan@u.a-ru.ac.jp

Name of contact person

1st name	Sechang
Middle name
Last name	Oh

Organization

R Professional University of Rehabilitation

Division name

Department of Physical Therapy, Faculty of Rehabilitation

Zip code

300-0032

Address

2-10-35 Kohoku, Tsuchiura, Ibaraki 300-0032, Japan

TEL

029-824-7611

Homepage URL

Email

o-sechan@u.a-ru.ac.jp

Institute

R Professional University of Rehabilitation

Institute

Department

Personal name

Organization

R Professional University of Rehabilitation

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

DYPHI (provided AndanteFit on loan free of charge; no role in study design, data collection or analysis, manuscript preparation, or the decision to submit).

Organization

Research Ethics Review Committee, R Professional University Of Rehabilitation

Address

2-10-35 Kohoku, Tsuchiura, Ibaraki 300-0032, Japan

Tel

029-824-7611

Email

k-rinri@a-ru.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

10

Month

19

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

https://square.umin.ac.jp/jshp27/doc/27jshp_conferenceprogram_abstract.pdf

Number of participants that the trial has enrolled

67

Results

Only experiment 1 (Nishida) was presented at the 27th Annual Meeting of the Japan Society of Health Promotion on March 7, 2026. In the current pooled time analysis, digital and manual assessment times were 124.98+/-30.62 and 204.92+/-55.42 s (mean+/-SD), respectively. The paired mean difference (manual minus digital) was 79.94 s (95% CI 68.92-90.95; p<0.001).

Results date posted

2026

Year

10

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

As reported at the conference, included 67 community-dwelling older adults: 19 men and 48 women, with a mean age of 74.9 years.

Participant flow

The conference abstract reported 67 community-dwelling older adults assessed once with each method.

Adverse events

No adverse events, including falls, injuries, pain, or dizziness, were reported during or immediately after assessment. No assessments were discontinued for these reasons.

Outcome measures

1. Total assessment time
Mean total assessment time was 2.38 min with the digital method and 3.49 min with the manual method (p<0.001).

2. SPPB total score
Mean SPPB total scores were 10.54 with the digital method and 10.37 with the manual method (p=0.035).

3. Participant questionnaire
Favorable response percentages reported in the presentation slides (digital/manual) were overall satisfaction 77.6%/79.1% (p=0.82), acceptance of results 77.6%/76.1% (p=0.84), and understanding of instructions 85.1%/85.1% (p=1.00). None differed significantly between methods.

Plan to share IPD

Yes. De-identified analysis data may be shared upon reasonable request, subject to ethical approval and privacy requirements.

IPD sharing Plan description

De-identified data underlying the reported analyses may be shared upon reasonable request to the principal investigator. Requests will be reviewed in relation to the proposed research purpose, ethical approval, consent, and privacy requirements. Information allowing identification or re-identification will not be shared. The data to be provided, timing, and transfer method will be determined for each approved request.

Recruitment status

No longer recruiting

Date of protocol fixation

2024

Year

11

Month

06

Day

Date of IRB

2024

Year

12

Month

06

Day

Anticipated trial start date

2024

Year

12

Month

21

Day

Last follow-up date

2025

Year

12

Month

29

Day

Date of closure to data entry

2026

Year

04

Month

08

Day

Date trial data considered complete

2026

Year

06

Month

09

Day

Date analysis concluded

2026

Year

09

Month

10

Day

Other related information

This is retrospective registration after data collection and analysis. The ethics-approved protocol included comparisons of measurement accuracy, assessment efficiency, and participant satisfaction. The pooled analysis centered on SPPB assessment time and the outcome priorities were defined after data collection.
Participants were allocated alternately by arrival order to digital-first or manual-first assessment. No random-number sequence or allocation concealment was used.
Ethics approval R24-009 (December 6, 2024) covers both participant datasets and the assessor survey. Participants and assessors provided written consent, and an opt-out procedure was also implemented for participants.
The study used university internal research funding. DYPHI loaned equipment free of charge but had no role in study design, data collection or analysis, manuscript preparation, or submission decisions. No author has other financial ties to DYPHI.
Only part of the study results had been presented at a conference. The results of the pooled analysis were not included in that presentation and were unpublished before this registration.

Registered date

2026

Year

10

Month

19

Day

Last modified on

2026

Year

10

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072492