Effectiveness of the ARTHE-e App for Exercise Adherence in People With Knee Osteoarthritis: Protocol for a Randomized Controlled Trial (ARTHe 3)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Exercise Adherence Rating Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Exercise Adherence Rating Scale
时间窗: 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.
次要结局
- 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)
- Pain Visual Analog Scale(Inclusion, 2 months, 4 months and 6 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)