NCT07876011

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 15, 2026

Completed
Last Updated

October 15, 2026

Status Verified

October 1, 2026

Enrollment Period

10 months

First QC Date

October 1, 2026

Last Update Submit

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

EXPERIMENTAL

Participants 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.

Behavioral: AI-assited exercise

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.

AI-Assisted Exercise

Eligibility Criteria

Age52 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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

Locations