Knee OsteoarthritisARTH-e3NCT06359171
Effectiveness of the ARTH-e Application for Exercise Adherence in People With Knee Osteoarthritis : RCT
A study testing Application ARTH-e in people with Knee Osteoarthritis, run by University Hospital, Clermont-Ferrand at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Application ARTH-e
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 14 May 2024to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 40 and 85 years with uni or bilateral knee osteoarthritis according to EULAR (European League Against Rheumatism) criteria, symptomatic and diagnosed prior to inclusion by a specialist or not.
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Clermont-Ferrand
Clermont-Ferrand
CH Emile Roux
Le Puy-en-Velay
CHU Montpellier
Montpellier
CHU Nantes
Nantes
About this study
Official title: Effectiveness of the ARTHE-e App for Exercise Adherence in People With Knee Osteoarthritis: Protocol for a Randomized Controlled Trial (ARTHe 3)
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.
Read the detailed description
Knee osteoarthritis is the most common joint disease affecting the joint itself as well as the peri-articular structures in a global and progressive manner. It can affect all the joints of the body, with a predominance for those which undergo strong mechanical constraints such as the rachis, the hip or the knee. It is a chronic pathology correlated with age, since nearly one adult in two is affected by osteoarthritis.
Today, connected objects have taken a predominant place in the daily life of the majority of the population, including seniors. It is an object of communication and socialization as well as a major information tool. E-health applications are more and more numerous in the stores and are a tool for assistance, information and support already used in many fields. In the context of therapeutic education, it is a motivational tool that can accompany patients by adapting to their needs and progress compared to traditional self-exercise methods. Studies of the obstacles and levers for the use of smartphone applications in chronic pathologies such as low back pain support the development of this tool.
- Conditions
- Knee Osteoarthritis
- Being tested
- Application ARTH-e
- Keywords
- Knee osteoarthritis, e-health, app, effectiveness
- Medical subject headings
- Osteoarthritis, Knee, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application ARTH-eOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard care |
| Experimental group | Experimental | Standard care and participants use the ARTH-e application for 6 months Receives: Other: Application ARTH-e |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2, 4 and 6 months
Secondary outcomes (14)
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.
Measured: 2 months and 4 months
EPAP questionnaire
Identification of barriers and levers to regular physical activity using the EPAP questionnaire. This questionnaire contains 24 items on the facilities and obstacles encountered when engaging in physical activity. The maximum score for this questionnaire is 100 points. Responses range from "Strongly disagree" (0 points) to "Strongly agree" (4 points). Responses to this questionnaire will be collected at inclusion and at the end of the study.
Measured: Inclusion and 6 months
TSK questionnaire
Evaluation of fears and anxieties related to pain that may be experienced during physical exercise using the TSK questionnaire at inclusion and at the end of the study. This questionnaire contains 17 statements. Patients were asked to circle the number that best corresponded to them (4 points). Responses ranged from "Strongly disagree" (1 point) to "Strongly agree" (4 points). The maximum score is 68. The higher the score, the greater the level of kinesiophobia.
Measured: Inclusion and at 6 months
Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Comparison of the functional evaluation collected at inclusion and at 6 months of use of the application via the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire. This questionnaire consists of 17 statements answering the question "Over the last eight days, how difficult́ have you beeń doing each of the following activities?". Responses range from "absent" (0 points) to "extreme" (4 points). The maximum score is 68. A high score is predictive of functional deterioration.
Measured: Inclusion and 6 months
EQ-5D-3L questionnaire
Evaluation of quality of life using the EQ-5D-3L questionnaire. This questionnaire consists of two aspects: a descriptive system (EQ-5D) and a visual analogue scale (EQ-VAS). The questionnaire comprises five dimensions: mobility, personal care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, a few problems and extreme problems. The patient therefore ticks the box that seems most appropriate to their current state.
Measured: Inclusion and at 6 months
Mobility
Measurement of joint mobility with a goniometer (flexion/extension)
Measured: Inclusion and at 6 months
Average number of steps per day
Collection of average number of steps per day for 6 months during telephone calls (every 2 months). The GARMIN connected bracelet will allow us to collect the number of average steps per day (four measurement times over one week before each evaluation: inclusion, 2 months, 4 months and 6 months) via its GARMIN connect application.
Measured: Inclusion, 2,4,6 months
Parameters for use of the ARTHE application
Collection of parameters for use of the ARTHE application, if applicable (for the intervention group), the number of sessions carried out per week will be collected by extracting data from the application's production back office.
Measured: 2,4,6 months
Functional tests - 30 sec chair lifts
Functional tests: number of 30-second chair lifts at inclusion and at 6 months.The patient should remain in the sit-to-stand position for as long as possible (30 sec). The evaluator counts the number of sit-ups performed.
Measured: Inclusion and 6 months
Functional tests - Stair Climbing Test
Functional tests: Stair Climbing Test (in seconds) at inclusion and at 6 months. The patient will be asked to climb 1The patient will be asked to climb 11 steps (height 13.5cm), make a U-turn and descend them as quickly as possible, while maintaining safety during the test (no loss of balance). Climbing and descending time will be measured separately with a stopwatch. 1 steps (height 13.5cm), make a half-turn and descend them as quickly as possible, but keeping safe during the test (without loss of balance). Climbing and descending times will be measured separately with a stopwatch.
Measured: Inclusion and 6 months
Functional tests - 6MWT
Functional tests: 6-minute walk test (6 MWT) (in meters) at inclusion and at 6 months.This test carried out in a corridor with pads numbered from 1 to 60. The patient must walk back and forth for 6 minutes. The examiner measures the distance covered during these 6 minutes.
Measured: Inclusion and 6 months
Functional tests - quadriceps isometric strength test with dynamometer
Functional tests: quadriceps isometric strength test (in N/Kg)with a dynamometer at inclusion and at 6 months. The participant will be asked to push the leg forward as hard as possible (isometric contraction of the quadriceps) for 5 seconds. Three trial contractions will be performed with progressive effort (weak, medium and strong). Then, three consecutive maximum contractions will be recorded using a dynamometer. The maximum value will be recorded and normalized in relation to the patient's body mass [N/kg].
Measured: Inclusion and 6 months
Medico-economic analysis
Medico-economic analysis carried out using a data record (drug management, medical consultations, hospitalisations, use of alternative therapies, additional examinations, use of medical transport).
Measured: Inclusion and 6 months
Pain Visual Analog Scale
Change in the average level of pain over the last 3 days collected during the telephone interview using a 10-point Numerical Scale (0 = "No pain" to 10 = "Maximum imaginable pain") at inclusion, 2 months, 4 months and 6 months of use of the application.
Measured: Inclusion, 2 months, 4 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start14 May 2024
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06359171
- Sponsor's protocol ID
- RBHP 2023 LANHERS
- Acronym
- ARTH-e3
- Status last verified
- Sep 2025
- First submitted
- 13 Feb 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39832974
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the ARTHE-e App for Exercise Adherence in People With Knee Osteoarthritis: Protocol for a Randomized Controlled Trial (ARTHe 3)
- ClinicalTrials.gov ID
- NCT06359171
- Acronym / sponsor ID
- ARTH-e3 / RBHP 2023 LANHERS
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, e-health, app, effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 11 Apr 2024 (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.
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.
Detailed description
Knee osteoarthritis is the most common joint disease affecting the joint itself as well as the peri-articular structures in a global and progressive manner. It can affect all the joints of the body, with a predominance for those which undergo strong mechanical constraints such as the rachis, the hip or the knee. It is a chronic pathology correlated with age, since nearly one adult in two is affected by osteoarthritis.
Today, connected objects have taken a predominant place in the daily life of the majority of the population, including seniors. It is an object of communication and socialization as well as a major information tool. E-health applications are more and more numerous in the stores and are a tool for assistance, information and support already used in many fields. In the context of therapeutic education, it is a motivational tool that can accompany patients by adapting to their needs and progress compared to traditional self-exercise methods. Studies of the obstacles and levers for the use of smartphone applications in chronic pathologies such as low back pain support the development of this tool.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard care |
| Experimental group | Experimental | Other: Application ARTH-eStandard care and participants use the ARTH-e application for 6 months |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged between 40 and 85 years with uni or bilateral knee osteoarthritis according to EULAR (European League Against Rheumatism) criteria, symptomatic and diagnosed prior to inclusion by a specialist or not.
- 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.
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Application ARTH-eThe 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. | Other | Experimental group |
Primary outcome
Exercise Adherence Rating Scale
Time frame: 2, 4 and 6 months
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.
14 secondary outcomes
Exercise Adherence Rating Scale
Time frame: 2 months and 4 months
EPAP questionnaire
Time frame: Inclusion and 6 months
TSK questionnaire
Time frame: Inclusion and at 6 months
Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Time frame: Inclusion and 6 months
EQ-5D-3L questionnaire
Time frame: Inclusion and at 6 months
Mobility
Time frame: Inclusion and at 6 months
Average number of steps per day
Time frame: Inclusion, 2,4,6 months
Parameters for use of the ARTHE application
Time frame: 2,4,6 months
Functional tests - 30 sec chair lifts
Time frame: Inclusion and 6 months
Functional tests - Stair Climbing Test
Time frame: Inclusion and 6 months
Functional tests - 6MWT
Time frame: Inclusion and 6 months
Functional tests - quadriceps isometric strength test with dynamometer
Time frame: Inclusion and 6 months
Medico-economic analysis
Time frame: Inclusion and 6 months
Pain Visual Analog Scale
Time frame: Inclusion, 2 months, 4 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 39832974Pelletier-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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application ARTH-e in people with Knee Osteoarthritis, run by University Hospital, Clermont-Ferrand at 4 sites in France.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Adherence Rating Scale (time frame: 2, 4 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06359171, which also lists 1 linked publication.
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 28 Sep 2026.