Development of a Mobile APP to Promote Physical Activity in Individuals with Knee Osteoarthritis: a "Move for Knee" Study Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 150
- Primary Endpoint
- Brief Pain Inventory (BPI) and its two indexes (severity and interference indexes; BPI-SI, BPI-II)
Study Overview
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness of an app developed to provide useful guidance on physical activity for people with knee osteoarthritis.The main question it aims to answer is:
"What physical activity can I perform with knee osteoarthritis?" Researchers will compare use of app developed to provide physicial activity program versus educational advices (a look-alike substance that contains no drug) to see if APP works to treat pain and stiffness related to knee osteoarthritis.
Participants will:
Download and use APP Visit the clinic once every 4 weeks for checkups and tests
Detailed Description
In this no-profit, interventional, double-arm, monocentric study, men and women with unilateral or bilateral tibiofemoral KOA according to the American College of Rheumatology criteria for KOA, aged 45 to 70 years, and radiographic findings (Kellgren-Lawrence grade 1-3) referring to the Physical Medicine and Rehabilitation Unit, University of Campania "Luigi Vanvitelli", will be included. In this trial, the patients will be randomized into two groups:
- patients who will use the "Move for Knee" APP (intervention arm);
- patients who will be advised to engage in free physical activity (control arm). Patients will be directed to one of the arms through random sampling with consecutive 1:1 randomization (intervention:control).
The mobile APP called Move Your Knee is divided in 4 sections:
- Know Your Knee: this first section allows the collection of data entered by patients, useful for understanding their lifestyle habits and daily physical activity level, and information relating to KOA pathology.
At the end of the questionnaire, the algorithm integrated into the APP's computer code will allow the calculation of the patient's presumed level of physical activity. This will then be followed by the assignment of a specific form which includes the exercises and the related execution parameters (i.e. weekly frequency), and useful advice for safely carrying out the exercises to achieve the specific functional objectives. 2. Move Your Knee: in this section, the patient will be able to select the level of difficulty/intensity in performing the physical exercise (the more advanced levels are blocked until the previous objective is achieved).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients with unilateral or bilateral tibiofemoral osteoarthritis according to the American College of Rheumatology classification criteria for osteoarthritis, aged between 45 and 70 years, with radiographic findings (Kellgren-Lawrence grade 1-3)
- •Expression of consent to participate in the study through a signed informed consent form
- •Ability to understand and use the APP through a practical demonstration in an outpatient setting
Exclusion Criteria
- •Psychiatric disorders that could potentially invalidate informed consent
- •Pregnancy or breastfeeding
Outcomes
Primary Outcomes
Brief Pain Inventory (BPI) and its two indexes (severity and interference indexes; BPI-SI, BPI-II)
Time Frame: at 30 (T1), 90 (T2), and 180 days (T3)
multidimensional pain evaluation
Secondary Outcomes
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);(30 (T1), 90 (T2), and 180 days (T3))
- EUROQoL-5Dimension (EQ-5D).(at 30 (T1), 90 (T2), and 180 days (T3))
Investigators
Sara Liguori
doctor
University of Campania Luigi Vanvitelli