Knee OsteoarthritisET-AIARNCT07434011
Efficacy of Artificial Intelligence-Assisted Therapeutic Exercise in Patients With Knee Osteoarthritis
A study testing AI-Assisted Exercise Program and Paper-Based Home Exercise Program in people with Knee Osteoarthritis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Knee osteoarthritis is a common, chronic degenerative condition that causes pain, functional limitations, and reduced quality of life, especially in adults older than 50 years. Although clinical practice guidelines recommend therapeutic exercise and physical therapy as the first-line treatment, many patients do not… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- AI-Assisted Exercise Program and Paper-Based Home Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 13 May 2026to 15 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Having a planned knee arthroplasty (knee replacement) surgery.
- Knee prosthesis/arthroplasty in the most painful knee.
- Participation in a therapeutic exercise program for knee osteoarthritis within the past 6 weeks.
- Infiltration for knee osteoarthritis within the past 12 weeks.
- Inflammatory arthritic conditions.
- A fall in the past 12 months without medical clearance to perform unsupervised home exercise.
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- Being homebound during the past month without medical clearance to perform unsupervised home exercise.
- Failing the pre-exercise screening and not having medical clearance to perform unsupervised home exercise.
- Inability to communicate in Spanish.
- Any neurological or systemic disease that may limit participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Marcos José N Marcos José Navarro-Santana, 0034 91 394 15 24, marconav@ucm.es
About this study
Official title: Efficacy of Artificial Intelligence-Assisted Therapeutic Exercise in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
Knee osteoarthritis is a common, chronic degenerative condition that causes pain, functional limitations, and reduced quality of life, especially in adults older than 50 years. Although clinical practice guidelines recommend therapeutic exercise and physical therapy as the first-line treatment, many patients do not receive or adhere to the recommended programs. Digital health tools may help expand access and improve adherence by supporting home-based exercise.
This study is a parallel-group, randomized controlled clinical trial designed to evaluate the effectiveness of an artificial intelligence (AI)-assisted therapeutic exercise program delivered through a web-based app compared with a conventional home exercise program provided on paper in adults with knee osteoarthritis. The primary goal is to determine whether the AI-assisted program produces greater improvements in pain and knee-related function. Secondary goals include assessing changes in health-related quality of life and patient-perceived overall improvement, and comparing implementation outcomes like adherence, usability, satisfaction, self-efficacy for exercise, and use of the prescribed exercise resource (paper vs web platform). Participants will be recruited from the Department of Physical Medicine and Rehabilitation at Hospital Universitario 12 de Octubre and randomly assigned to either the AI-assisted exercise group or the conventional exercise group. The AI-assisted web app will adjust exercise dose and progression based on participant-reported pain and perceived exertion, using decision rules informed by clinical practice guidelines and high-quality research evidence. Both groups will complete a 6-week home-based exercise program and will also attend weekly in-person group sessions that will be held separately by study arm (experimental and control groups will not mix) to reduce cross-contamination and support masking procedures. These sessions will be used to address questions, reinforce the protocol, and monitor for adverse events. Clinical outcomes will include pain intensity (visual analog scale), knee-related disability and function (WOMAC), health-related quality of life (EQ-5D), and patient global rating of change (GROC). Physical performance outcomes (30-second Chair Stand Test and Stair Climb Test) will be assessed at baseline and 1 week after completion of the 6-week intervention. Assessments will be conducted at baseline, one week after the 6-week intervention, and at 3 and 6 months after the intervention, with the exception of physical performance outcomes, which will be assessed at baseline and 1 week post-intervention.
- Conditions
- Knee Osteoarthritis
- Being tested
- AI-Assisted Exercise Program, Paper-Based Home Exercise Program
- Keywords
- osteoarthritis, knee, exercise, digital intervention
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Assisted Exercise ProgramOther
Participants will complete a 6-week home-based therapeutic exercise program delivered through an AI-assisted web application. The program will be individualized and updated based on participant-reported pain and perceived exertion, which will be used to guide exercise dose and progression (e.g., progression/regression, load adjustments, and exercise variants) according to guideline-informed decision rules embedded in the platform. Participants will also attend weekly in-person, arm-specific group sessions (experimental-only) for protocol reinforcement, questions, and adverse event monitoring.
Paper-Based Home Exercise ProgramOther
Participants will complete a 6-week home-based therapeutic exercise program provided in paper format (printed exercise materials). The program will follow a conventional, predefined progression consistent with usual care and will not incorporate real-time, individualized adjustments based on symptom/effort inputs. Participants will also attend weekly in-person, arm-specific group sessions (control-only) for protocol reinforcement, questions, and adverse event monitoring.
| Study group | Role | What they receive |
|---|---|---|
| AI-Assisted Therapeutic Exercise (Web App) | Experimental | Participants will complete a 6-week home-based therapeutic exercise program delivered through an AI-assisted web application. The program will be individualized and updated based on participant-reported pain and perceived exertion, which will be used to guide exercise dose and progression (e.g., progression/regression, load adjustments, and exercise variants) according to guideline-informed decision rules embedded in the platform. Participants will also attend weekly in-person, arm-specific group sessions (experimental-only) for protocol reinforcement, questions, and adverse event monitoring. Receives: Other: AI-Assisted Exercise Program |
| Usual Care (Paper-Based Home Exercise Program) | Active comparator | Participants will complete a 6-week home-based therapeutic exercise program provided in paper format (printed exercise materials). The program will follow a conventional, predefined progression consistent with usual care and will not incorporate real-time, individualized adjustments based on symptom/effort inputs. Participants will also attend weekly in-person, arm-specific group sessions (control-only) for protocol reinforcement, questions, and adverse event monitoring. Receives: Other: Paper-Based Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a single 11-point numerical rating scale widely validated across different patient populations, where 0 represents no pain and 10 represents the worst possible pain. Data obtained through the NPRS are easy to document, intuitively interpretable and meet regulatory requirements for pain assessment and documentation.
Measured: Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Secondary outcomes (5)
Disability
Pain, stiffness and self-reported physical function will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index short form (WOMAC-SF), a patient-reported outcome measure designed to quantify symptom severity and functional limitations typically associated with hip and knee osteoarthritis. Items will be summed to obtain a total score ranging from 0 to 44 points, where higher results indicate worse symptoms and greater functional limitation.
Measured: Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Health-related quality of life
Health-related quality of life will be assessed using the EuroQol EQ-5D-5L, a standardized, generic measure of self-reported health status widely used in clinical and health-economic research. The EQ-5D-5L comprises two components: (1) a descriptive system and (2) a visual analogue scale (EQ VAS). The descriptive system covers five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across five severity levels (from no problems to extreme problems). Responses are combined into a 5-digit health state (e.g., 11,121), which is then converted into a single utility index using a country-specific value set; in this study, the Spanish value set will be applied for index derivation. The EQ VAS records the participant's overall health "today" on a 0-100 scale, where 0 represents the worst imaginable health and 100 the best imaginable health. The EQ-5D-5L has demonstrated validity and provides reference norms for the Spanish population.
Measured: Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Lower-limb functional performance
Lower-limb functional performance will be assessed using the 30-Second Chair Stand Test (30CST), a pragmatic, clinic-friendly measure of functional strength and endurance of the lower extremities. In this test, participants will be instructed to rise to a full stand and sit down as many times as possible within 30 seconds, starting from a standard chair (without armrests), with arms crossed over the chest (or following a standardized alternative if needed for safety). The primary outcome is the number of fully completed sit-to-stand repetitions in 30 seconds, where higher values indicate better functional performance.
Measured: Baseline and 1 week post-intervention
Lower-limb stair-climbing function
Lower-limb stair-climbing function will be assessed using a Timed Stair Test consisting of 11 steps, a pragmatic measure of lower-extremity functional capacity during stair ascent and descent. Participants will be instructed to ascend and then descend a flight of 11 stairs as quickly and safely as possible, starting from a standardized position. The primary outcome will be time to completion (seconds), recorded from the initiation of movement to the moment the participant returns to the starting level after completing both ascent and descent; shorter times indicate better lower-limb function.
Measured: Baseline and 1 week post-intervention
Perceived overall change (Patient Global Rating of Change, GROC)
Participants' perceived overall change will be assessed using the Patient Global Rating of Change (GROC), a single-item anchor measure designed to capture the participant's global perception of improvement or deterioration since baseline. Participants will be asked to rate how their condition has changed compared with the start of the study on a 15-point scale ranging from -7 to +7, where -7 indicates "a very great deal worse," 0 indicates "no change," and +7 indicates "a very great deal better." The primary outcome will be the GROC score at each follow-up, with positive values reflecting improvement and negative values reflecting worsening.
Measured: 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start13 May 2026
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434011
- Sponsor's protocol ID
- 25/753
- Acronym
- ET-AIAR
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artificial Intelligence-Assisted Therapeutic Exercise in Patients With Knee Osteoarthritis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07434011
- Acronym / sponsor ID
- ET-AIAR / 25/753
- Conditions
- Knee Osteoarthritis
- Keywords
- osteoarthritis, knee, exercise, digital intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Hospital Universitario 12 de Octubre
- Study start
- 13 May 2026 (actual)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 25 Feb 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.
Knee osteoarthritis is a common, chronic degenerative condition that causes pain, functional limitations, and reduced quality of life, especially in adults older than 50 years. Although clinical practice guidelines recommend therapeutic exercise and physical therapy as the first-line treatment, many patients do not receive or adhere to the recommended programs. Digital health tools may help expand access and improve adherence by supporting home-based exercise.
This study is a parallel-group, randomized controlled clinical trial designed to evaluate the effectiveness of an artificial intelligence (AI)-assisted therapeutic exercise program delivered through a web-based app compared with a conventional home exercise program provided on paper in adults with knee osteoarthritis. The primary goal is to determine whether the AI-assisted program produces greater improvements in pain and knee-related function. Secondary goals include assessing changes in health-related quality of life and patient-perceived overall improvement, and comparing implementation outcomes like adherence, usability, satisfaction, self-efficacy for exercise, and use of the prescribed exercise resource (paper vs web platform). Participants will be recruited from the Department of Physical Medicine and Rehabilitation at Hospital Universitario 12 de Octubre and randomly assigned to either the AI-assisted exercise group or the conventional exercise group. The AI-assisted web app will adjust exercise dose and progression based on participant-reported pain and perceived exertion, using decision rules informed by clinical practice guidelines and high-quality research evidence. Both groups will complete a 6-week home-based exercise program and will also attend weekly in-person group sessions that will be held separately by study arm (experimental and control groups will not mix) to reduce cross-contamination and support masking procedures. These sessions will be used to address questions, reinforce the protocol, and monitor for adverse events. Clinical outcomes will include pain intensity (visual analog scale), knee-related disability and function (WOMAC), health-related quality of life (EQ-5D), and patient global rating of change (GROC). Physical performance outcomes (30-second Chair Stand Test and Stair Climb Test) will be assessed at baseline and 1 week after completion of the 6-week intervention. Assessments will be conducted at baseline, one week after the 6-week intervention, and at 3 and 6 months after the intervention, with the exception of physical performance outcomes, which will be assessed at baseline and 1 week post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-Assisted Therapeutic Exercise (Web App) | Experimental | Other: AI-Assisted Exercise ProgramParticipants will complete a 6-week home-based therapeutic exercise program delivered through an AI-assisted web application. The program will be individualized and updated based on participant-reported pain and perceived exertion, which will be used to guide exercise dose and progression (e.g., progression/regression, load adjustments, and exercise variants) according to guideline-informed decision rules embedded in the platform. Participants will also attend weekly in-person, arm-specific group sessions (experimental-only) for protocol reinforcement, questions, and adverse event monitoring. |
| Usual Care (Paper-Based Home Exercise Program) | Active comparator | Other: Paper-Based Home Exercise ProgramParticipants will complete a 6-week home-based therapeutic exercise program provided in paper format (printed exercise materials). The program will follow a conventional, predefined progression consistent with usual care and will not incorporate real-time, individualized adjustments based on symptom/effort inputs. Participants will also attend weekly in-person, arm-specific group sessions (control-only) for protocol reinforcement, questions, and adverse event monitoring. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Having a planned knee arthroplasty (knee replacement) surgery.
- Knee prosthesis/arthroplasty in the most painful knee.
- Participation in a therapeutic exercise program for knee osteoarthritis within the past 6 weeks.
- Infiltration for knee osteoarthritis within the past 12 weeks.
- Inflammatory arthritic conditions.
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-Assisted Exercise ProgramParticipants will complete a 6-week home-based therapeutic exercise program delivered through an AI-assisted web application. The program will be individualized and updated based on participant-reported pain and perceived exertion, which will be used to guide exercise dose and progression (e.g., progression/regression, load adjustments, and exercise variants) according to guideline-informed decision rules embedded in the platform. Participants will also attend weekly in-person, arm-specific group sessions (experimental-only) for protocol reinforcement, questions, and adverse event monitoring. | Other | AI-Assisted Therapeutic Exercise (Web App) |
| Paper-Based Home Exercise ProgramParticipants will complete a 6-week home-based therapeutic exercise program provided in paper format (printed exercise materials). The program will follow a conventional, predefined progression consistent with usual care and will not incorporate real-time, individualized adjustments based on symptom/effort inputs. Participants will also attend weekly in-person, arm-specific group sessions (control-only) for protocol reinforcement, questions, and adverse event monitoring. | Other | Usual Care (Paper-Based Home Exercise Program) |
Primary outcome
Pain Intensity
Time frame: Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a single 11-point numerical rating scale widely validated across different patient populations, where 0 represents no pain and 10 represents the worst possible pain. Data obtained through the NPRS are easy to document, intuitively interpretable and meet regulatory requirements for pain assessment and documentation.
5 secondary outcomes
Disability
Time frame: Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Health-related quality of life
Time frame: Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Lower-limb functional performance
Time frame: Baseline and 1 week post-intervention
Lower-limb stair-climbing function
Time frame: Baseline and 1 week post-intervention
Perceived overall change (Patient Global Rating of Change, GROC)
Time frame: 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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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.
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-Assisted Exercise Program and Paper-Based Home Exercise Program in people with Knee Osteoarthritis, run by Universidad Complutense de Madrid at 1 site in Spain.
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 0 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 18 May 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-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 18 May 2026.