Tokyo, Oct. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063338) titled 'Comparison of Digital and Manual Physical Fitness Assessment in Older Adults' on Oct. 19.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - R Professional University of Rehabilitation
Condition:
Condition - Age-related decline in physical function
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
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 Size - 150
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072492
Disclaimer: Curated by HT Syndication.