An interventional study of AI-Assisted Exercise Program and Paper-Based Home Exercise Program in Knee Osteoarthritis, sponsored by Universidad Complutense de Madrid. Recruiting at 1 site in Spain. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
Among 100 studies in Osteoarthritis, Knee with a site in Spain — 16 open to participants now, 19 under way, 3 of them phase 3. Osteoarthritis, Knee · Spain.
Among the 100 studies in Osteoarthritis, Knee with a site in Spain, this one is the 48th largest by planned enrollment of the 86 interventional ones, is one of 9 that started in 2026, is one of 47 with no phase, reaches primary completion later than 8 of the 18 other live ones, and was the 94th registered.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 84 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →16 of the 100 studies in Osteoarthritis, Knee with a site in Spain are open now, in 12 countries. Each count lists the studies.
Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
The full table on the hub →100 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 9 started in 2026.
Median enrollment 100 across the 86 interventional studies, 153 across the 14 observational. Of the 71 that completed or were terminated, 19 (27%) have results posted.
43 of 100 have an industry lead sponsor. The 10 most frequent:
Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
Universidad Complutense de Madrid has 1 study filed under Osteoarthritis, Knee — fewer than ten, so there is no comparison to draw.
4 of the studies in Osteoarthritis, Knee with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06721897University of JaénEffectiveness of a Prehabilitation Program for Hip or Knee Arthroplasty Surgery. | 2026-11-30 |
| NCT07434011Universidad Complutense de MadridEfficacy of Artificial Intelligence-Assisted Therapeutic Exercise in Patients With Knee Osteoarthritis | 2027-03-15 |
| NCT07886697Universidad Rey Juan CarlosLow-Dose Radiotherapy for Painful Knee Osteoarthritis | 2027-06-30 |
| NCT07870967Universidad Católica San Antonio de MurciaUndenatured Type II Collagen for Knee Osteoarthritis Pain | 2027-07 |
Among the 100 studies in Osteoarthritis, Knee with a site in Spain, from their registry updates:
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.
Inclusion Criteria (based on National Institute for Health and Care Excellence (NICE) guidance):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: AI-Assisted Exercise Program
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.
Other: Paper-Based Home Exercise Program
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.
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.
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.
Time frame: Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 week post-intervention, 3 months post-intervention and 6 months post-intervention
Started May 2026 (actual). Primary completion is estimated for Mar 2027, 10 months after the start.
Of 1,111 non-industry interventional studies with no phase under Osteoarthritis, Knee, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's planned 10 months is below that.
Counting every sponsor, half of 1,251 studies reached it within 18 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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