Effectiveness of the ARTHE-e App for Exercise Adherence in People With Knee Osteoarthritis: Protocol for a Randomized Controlled Trial (ARTHe 3)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Exercise Adherence Rating Scale
- Status
- Completed
- Last Updated
- 4 months ago
Overview
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.
Investigators
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
- •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
Outcomes
Primary Outcomes
Exercise Adherence Rating Scale
Time Frame: 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.
Secondary Outcomes
- 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)
- Mobility(Inclusion and at 6 months)
- Average number of steps per day(Inclusion, 2,4,6 months)
- Parameters for use of the ARTHE application(2,4,6 months)
- Functional tests - 30 sec chair lifts(Inclusion and 6 months)
- Functional tests - Stair Climbing Test(Inclusion and 6 months)
- Functional tests - 6MWT(Inclusion and 6 months)
- Functional tests - quadriceps isometric strength test with dynamometer(Inclusion and 6 months)
- Medico-economic analysis(Inclusion and 6 months)
- Pain Visual Analog Scale(Inclusion, 2 months, 4 months and 6 months)