Clinical trial NCT06647446: Improvements in Function and Pain in the Rehabilitation of Patients with Knee Osteoarthritis Using an Exercise Program Telemonitored Compared to Conventional Treatment
Official title: Improvements in Function and Pain in the Rehabilitation of Patients with Knee Osteoarthritis Using an Exercise Program Telemonitored Compared to Conventional Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis is a very prevalent pathology after the fifth decade of life. It usually appears in the hip and hand, although its presence in the knee is even greater, with a prevalence in subjects over 45 years of age of 19% radiographically (radiographic findings without taking symptoms into account) and 7% in the symptomatic population, for those over 60 years of age, 37% radiographic and 12% symptomatic and finally, for those over 75 years of age there was 50% of osteoarthritis of the knee diagnosed by radiographs and 33% were symptomatic. There are gender differences: the lifetime risk of suffering knee osteoarthritis is estimated at 40% for men and 47% for women. Furthermore, the impact of this pathology is significant, being the most frequent cause of gait-related disability in adults in the United States.

Different approaches have been proposed for the treatment of knee osteoarthritis. Currently, clinical practice guidelines place therapeutic exercise and education as the first line of treatment, reserving joint replacement surgery in case of failure of conservative treatment and only if there is severe disability.

In recent years, due to the pandemic, there has been an accelerated development of telemedicine and telerehabilitation in all its aspects. Applications and websites have been developed for online rehabilitation. An example of this is TRAK, a telerehabilitation web tool that allows the creation of a profile for each patient and the design of personalized exercise programs and the periodization of the sessions to be carried out. During the execution of the exercises, the screen of the split phone will appear, displaying on one side the execution of the exercise by a model and on the other side, the patient sees himself performing the exercise. This tool allows the monitoring of the therapeutic exercise without the need to go to a consultation or to be in front of a physiotherapist, reducing the economic and time investment.

Thus, the present work tries to compare the treatment with exercises monitored by means of the TRAK application with the performance of the same exercises, without the help of this tool.


Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with osteoarthritis of the knee.
* Age \>45 years.
* The patient presents with knee pain during physical activity.
* The patient reports knee symptoms in the last month.
* The patient has a mobile phone with internet access.

Exclusion Criteria:

* Previous knee surgeries.
* Planned surgeries during the duration of the trial.
* Patient is currently undergoing physical therapy.
* Patient currently has severe pathology that may compromise participation in the exercise program (advanced COPD, cardiac or arterial disease).
* Associated rheumatic pathology (fibromyalgia, gout, rheumatoid arthritis).
* BMI \>30.
* Having completed a strengthening exercise program in the last year.
* Visual disturbances that prevent being able to observe the cell phone screen correctly.
* Lack of digital skills in the use of the Internet with the cell phone.

Primary outcomes:
measure: Disability
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Pain
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Secondary outcomes:
measure: 40 metre fast-paced walk
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: 30 seconds chair-stand test
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Kinesiphobia
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Medication intake
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Adherence
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
measure: Adherence
timeFrame: Baseline; 8 weeks measurement (post intervention); 32 weeks measurement (24 weeks post intervention)
Other outcomes:
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