Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From KOA: RCT

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis

• Registration Number: NCT06359171
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-11
• Status Verified: 2024-05
• Study Start: 2024-05-14
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17
• Primary Completion: 2025-06-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Exercise Adherence Rating Scale	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.

Secondary Outcome Measures

Name	Time	Method
Pain Visual Analog Scale	Inclusion, 2 months, 4 months and 6 months	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.
TSK questionnaire	Inclusion and at 6 months	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.
Parameters for use of the ARTHE application	2,4,6 months	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.
Functional tests - Stair Climbing Test	Inclusion and 6 months	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.
EQ-5D-3L questionnaire	Inclusion and at 6 months	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.
Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire	Inclusion and 6 months	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.
Average number of steps per day	Inclusion, 2,4,6 months	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.
Mobility	Inclusion and at 6 months	Measurement of joint mobility with a goniometer (flexion/extension)
EPAP questionnaire	Inclusion and 6 months	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.
Functional tests - 30 sec chair lifts	Inclusion and 6 months	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.
Functional tests - quadriceps isometric strength test with dynamometer	Inclusion and 6 months	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 \[N/kg\].
Medico-economic analysis	Inclusion and 6 months	Medico-economic analysis carried out using a data record (drug management, medical consultations, hospitalisations, use of alternative therapies, additional examinations, use of medical transport).
Functional tests - 6MWT	Inclusion and 6 months	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.

Trial Locations

Locations (4)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CH Emile Roux; 🇫🇷 Le Puy-en-Velay, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Nantes; 🇫🇷 Nantes, France