Effectiveness of the ARTH-e Application for Exercise Adherence in People With Knee Osteoarthritis : RCT

NCT06359171 | Completed

• 1 other identifier: RBHP 2023 LANHERS
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief Summary

The aim of this study is to investigate the effectiveness of a smartphone-based e-health application (intervention group) compared with standard care (control group) in terms of changes in adherence in patients with knee osteoarthritis using the EARS questionnaire. In addition, other questionnaires presented in the appendix (KOOS, TSK, EPAP, EQ-5D-3L, pain) will be given to all patients in order to meet the secondary evaluation criteria.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; e-health; app; effectiveness

Outcome Measures

Primary Outcomes (1)

• Exercise Adherence Rating Scale

  This questionnaire, validated in French, comprises 6 items. Scoring is based on a 5-point Likert scale (from 0 - "completely agree" to 4 - "completely disagree"). This results in a score ranging from 0 to 24. A higher score indicates greater support. The evolution of the score (i.e. the kinetics) will be compared between randomisation groups using a mixed model, taking into account the group, time and time x group interaction effects; it is therefore the value of EARS and not a variation that will be considered for the analysis.

  6 months

Secondary Outcomes (14)

• Exercise Adherence Rating Scale

  2 months and 4 months

• EPAP questionnaire

  Inclusion and 6 months

• TSK questionnaire

  Inclusion and at 6 months

• Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire

  Inclusion and 6 months

• EQ-5D-3L questionnaire

  Inclusion and at 6 months

Study Arms (2)

Control

NO INTERVENTION

Standard care

Experimental group

EXPERIMENTAL

Standard care and participants use the ARTH-e application for 6 months

Other: Application ARTH-e

Interventions

Application ARTH-e OTHER

The ARTH-e application must be downloaded via the PlayStore or Applestore platform on phone and/or tablet. Once the application has been downloaded, the patient must scan a QRcode sent by the CHU to anonymize the data. Participants will have 6 months to use the application at their convenience.

Experimental group

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having an involvement of at least one knee.
• Own a smartphone or tablet running at least Android 5 or iOS 11.
• Able to give written consent to participate in the study.
• Beneficiary of a social security plan.

You may not qualify if:

• pregnant or breast-feeding women Patients under legal protection measures (guardianship, curatorship or protection of the court)
• Patients who have undergone knee surgery (total or partial prosthesis, tibial transposition surgery, arthrodesis)
• Patients with inflammatory rheumatism
• Patients with neurological sequelae
• Contraindications to physical activity for medical reasons
• Patients with difficulties in understanding the French language
• Refusal to participate
• Patients who have already participated in the ARTH-e 2 study or who are already included in a research protocol that could influence the current protocol

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (4)

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CH Emile Roux

Le Puy-en-Velay, France

Location

CHU Montpellier

Montpellier, France

Location

CHU Nantes

Nantes, France

Location

Related Publications (1)

• Pelletier-Visa M, Dobija L, Bonhomme A, Lanhers C, Pereira B, Coudeyre E. Effectiveness of the ARTHE-e app for exercise adherence in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2025 Jan 20;15(1):e088860. doi: 10.1136/bmjopen-2024-088860.

  PMID: 39832974 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Alzheimer Disease

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigating physician who will carry out the inclusion visit will know the result of the randomization which will be carried out during the consultation. The second evaluator, who will carry out the end-of-study visit, will not know the patient's group. As a result, the assessment will be neutral and the second assessor will evaluate the patient without being influenced by the study group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators plan to conduct a multicenter, prospective, comparative, randomised trial (1:1). Participants will be randomized to one of two groups: control or experimental. In each group (control or experimental), each participant will be able to use the application for a period of 6 months. * Control group: physician's advice with examples of self-exercise (knee osteoarthritis booklet) + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet. * Intervention group: download the application + adapted physical activity session with an APA/physiotherapist + delivery of the knee osteoarthritis booklet + prescription for 12 physiotherapy sessions + delivery of a GARMIN connected bracelet.

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: April 11, 2024
• Study Start: May 14, 2024
• Primary Completion: November 6, 2025
• Study Completion: November 6, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)