Fall Risk in Middle-Aged and Older AdultsNCT07876011
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
A study testing AI-assited exercise in people with Fall Risk in Middle-Aged and Older Adults, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 52 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall Risk in Middle-Aged and Older Adults
- What is being tested?
- AI-assited exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital Chongli Hospital, Yingbin Road, Chongli District, Zhangjiakou, Hebei, China
Zhangjiakou, Hebei
About this study
Official title: 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
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.
- Being tested
- AI-assited exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assited exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: AI-assited exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait speed
Measured: Baseline and immediately after completion of the 4-week intervention
Secondary outcomes (3)
sway area
Area of the 95% confidence ellipse of the acceleration signal in postural sway data
Measured: Baseline and immediately after completion of the 4-week intervention
PFC_HbO
Change in prefrontal cortex oxygenated hemoglobin concentration (fNIRS)
Measured: Baseline and immediately after completion of the 4-week intervention
double support
Mean percentage of the gait cycle spent in double-support phase across both lower limbs
Measured: Baseline and immediately after completion of the 4-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start8 Jan 2025
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall Risk in Middle-Aged and Older AdultsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhenlong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876011
- Sponsor's protocol ID
- M20260775
- Other IDs
- V1719219040846
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07876011
- Acronym / sponsor ID
- M20260775
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Exercise | Experimental | Behavioral: AI-assited exerciseParticipants 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. |
Who may qualify
- Ages
- 52 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assited exerciseA 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. | Behavioural | AI-Assisted Exercise |
Primary outcome
gait speed
Time frame: Baseline and immediately after completion of the 4-week intervention
3 secondary outcomes
sway area
Time frame: Baseline and immediately after completion of the 4-week intervention
PFC_HbO
Time frame: Baseline and immediately after completion of the 4-week intervention
double support
Time frame: Baseline and immediately after completion of the 4-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-assited exercise in people with Fall Risk in Middle-Aged and Older Adults, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait speed (time frame: Baseline and immediately after completion of the 4-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.