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| Name | Class |
|---|---|
| Hospital Universitario 12 de Octubre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-Assisted Exercise Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria (based on National Institute for Health and Care Excellence (NICE) guidance):
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | Madrid | 28041 | Spain |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Paper-Based Home Exercise Program | Other | 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. |
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| 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. | 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. | 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. | 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. | 1 week post-intervention, 3 months post-intervention and 6 months post-intervention |
| D001519 |
| Behavior |