Short-term Changes in Postural Sway, Gait, and fNIRS-derived Cortical Metrics After a 4-week AI-assisted Exercise Program: a Single-arm Pre-post Study
基于机器视觉与深度学习技术的无标记老年人跌倒风险评估智能诊疗系统研发与社区服务推广
2 other identifiers
interventional
50
1 country
1
Brief Summary
This single-arm pre-post study will enroll 50 participants aged 52-65 years who will undergo a 4-week AI-assisted exercise intervention. Postural balance, functional near-infrared spectroscopy (fNIRS), and three-dimensional motion capture data will be assessed before and after the intervention under different task conditions. During the dual-task condition, the correct response rate (CRR) during serial subtraction of 7 will be recorded. Adverse events occurring during the intervention will also be monitored and recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2025
CompletedFirst Submitted
Initial submission to the registry
October 1, 2026
CompletedFirst Posted
Study publicly available on registry
October 15, 2026
CompletedOctober 15, 2026
October 1, 2026
10 months
October 1, 2026
October 8, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
gait speed
Baseline and immediately after completion of the 4-week intervention
Secondary Outcomes (3)
sway area
Baseline and immediately after completion of the 4-week intervention
PFC_HbO
Baseline and immediately after completion of the 4-week intervention
double support
Baseline and immediately after completion of the 4-week intervention
Other Outcomes (2)
lateral variability
Baseline and immediately after completion of the 4-week intervention
Global efficiency (fNIRS)
Baseline and immediately after completion of the 4-week intervention
Study Arms (1)
AI-Assisted Exercise
EXPERIMENTALParticipants will receive a 4-week combined exercise intervention, 5 days per week with 2 days of rest. Each 60-minute session will include 10 minutes of warm-up, 20 minutes of AI-assisted lower-extremity strength and functional training, 20 minutes of aerobic cycling, and 10 minutes of cool-down. The AI-assisted training system will provide individualized exercise guidance, real-time monitoring, and movement correction. Aerobic cycling will be performed at approximately 55% heart rate reserve using a recumbent cycle ergometer. Safety and adverse events will be monitored throughout the intervention.
Interventions
A 4-week AI-assisted combined exercise intervention consisting of lower-extremity strength and functional training and aerobic cycling, delivered 5 days per week with individualized guidance and real-time movement monitoring.
Eligibility Criteria
You may qualify if:
- Age 52-70 years, regardless of sex.
- Able to walk independently for at least 10 meters without any assistive device.
- Normal or corrected-to-normal vision and normal hearing, with the ability to understand and complete all study procedures as instructed.
- Willing to participate in the study and provide written informed consent.
You may not qualify if:
- Severe musculoskeletal, neurological, cardiopulmonary, or psychiatric diseases or a history of such conditions.
- Severe cognitive impairment.
- A history of drug or substance abuse within the past 3 months.
- Any other condition that may affect participation in or the assessment of the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital Chongli Hospital, Yingbin Road, Chongli District, Zhangjiakou, Hebei, China
Zhangjiakou, Hebei, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Researcher, Associate Chief Physician
Study Record Dates
First Submitted
October 1, 2026
First Posted
October 15, 2026
Study Start
January 8, 2025
Primary Completion
October 20, 2025
Study Completion
October 20, 2025
Last Updated
October 15, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will not share