NCT07434011

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
10mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress3%
May 2026Mar 2027

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 13, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

May 18, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 19, 2026

Last Update Submit

May 13, 2026

Conditions

Knee Osteoarthritis

Keywords

osteoarthritiskneeexercisedigital intervention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Disability

    Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention

  • Health-related quality of life

    Baseline, 1 week post-intervention, 3 months post-intervention and 6 months post-intervention

  • Lower-limb functional performance

    Baseline and 1 week post-intervention

  • Lower-limb stair-climbing function

    Baseline and 1 week post-intervention

  • Perceived overall change (Patient Global Rating of Change, GROC)

    1 week post-intervention, 3 months post-intervention and 6 months post-intervention

Study Arms (2)

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.

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.

Other: Paper-Based Home Exercise Program

Interventions

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.

AI-Assisted Therapeutic Exercise (Web App)
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.

Usual Care (Paper-Based Home Exercise Program)

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical criteria for KOA: age ≥45 years, activity-related knee pain, and morning knee stiffness lasting ≤30 minutes.
  • Knee pain for 3 months or longer.
  • Knee pain on most days during the previous month.
  • Overall knee pain intensity ≥4 on an 11-point Numerical Rating Scale (NRS; 0-10) during the previous week.
  • Ownership of a smartphone and ability to use a mobile application.
  • Internet access at home and/or via the mobile phone.
  • Ability to provide informed consent, participate, and complete study assessments.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

May 13, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

May 18, 2026

Record last verified: 2026-02

Locations

ES(1)