Clinical trial NCT06359171: Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From KOA: RCT
Official title: Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From Knee Osteoarthritis: Randomized Controlled Trial (ARTHe 3)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
e-health
app
effectiveness
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators plan to conduct a multicenter, prospective, comparative, randomised trial. 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Exercise Adherence Rating Scale
timeFrame: 2, 4 and 6 months
Secondary outcomes:
measure: Pain Visual Analog Scale
timeFrame: Inclusion, 2 months, 4 months and 6 months
measure: EPAP questionnaire
timeFrame: Inclusion and 6 months
measure: TSK questionnaire
timeFrame: Inclusion and at 6 months
measure: Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
timeFrame: Inclusion and 6 months
measure: EQ-5D-3L questionnaire
timeFrame: Inclusion and at 6 months
measure: Mobility
timeFrame: Inclusion and at 6 months
measure: Average number of steps per day
timeFrame: Inclusion, 2,4,6 months
measure: Parameters for use of the ARTHE application
timeFrame: 2,4,6 months
measure: Functional tests - 30 sec chair lifts
timeFrame: Inclusion and 6 months
measure: Functional tests - Stair Climbing Test
timeFrame: Inclusion and 6 months
measure: Functional tests - 6MWT
timeFrame: Inclusion and 6 months
measure: Functional tests - quadriceps isometric strength test with dynamometer
timeFrame: Inclusion and 6 months
measure: Medico-economic analysis
timeFrame: Inclusion and 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Le Puy-en-Velay
country: France
facility: CH Emile Roux
city: Montpellier
country: France
facility: CHU Montpellier
city: Nantes
country: France
facility: CHU Nantes
Study officials:
References: