Mobile App Use for Physical Activity in Knee Osteoarthritis (moveforknee)

February 6, 2025 updated by: Sara Liguori, University of Campania Luigi Vanvitelli

Development of a Mobile APP to Promote Physical Activity in Individuals with Knee Osteoarthritis: a "Move for Knee" Study Protocol

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. 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).

    There are 5 levels, each marked by an evocative image that summarizes the functional meaning and, therefore, facilitates the identification of the type of user (in particular, from the most advanced level: "Hawk"; "Tiger"; "Bull", "Turtle", "Sloth").

    Once the exercise program has been started, the patient finds the indications/advice for carrying out each exercise (duration, series and repetitions). Through the motion capture function, he can record the exercise he performed, to check with your doctor the appropriateness and safety of its execution. The video obtained from this recording is saved in the APP's Database (DB) and can be transferred to the doctor via Chat.

  3. Step by step: through this section, patients have the opportunity to record and monitor daily progress, obtaining a real-time view of their progress.
  4. Chat: to facilitate direct contact with the doctor, the APP is equipped with a native instant messaging service, through which patients can directly contact their doctor by communicating and sharing files and videos useful for monitoring.

The system is completed with a control panel that is used by the doctor via terminal/PC. This tool allows:

  1. registration of the patient on a specific web platform;
  2. access to the patient files associated with the referring doctor;
  3. patient monitoring, viewing the patient's progress to monitor adherence to use;
  4. access to Chat. Patients will be visited at baseline corresponding to enrollment in the study (T0), and at 30 (T1), 90 (T2), and 180 days (T3).

At all time points patients will be evaluated with the following protocol:

  • multidimensional pain evaluation with

    • the Brief Pain Inventory (BPI) and its two indexes (severity and interference indexes; BPI-SI, BPI-II);
    • the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, for the neuropathic component of pain;
  • stiffness and function through Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);
  • quality of life through EUROQoL-5Dimension (EQ-5D). For patients in the intervention group, questions related to the "user experience" and any adverse effects related to the APP will be included through an open-ended question "describe your experience with the APP" at 30 (T1), 90 (T2), and 180 days (T3).

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention
- patients who will use the "Move for Knee" APP (intervention arm);
Behavioral: use the "Move for Knee" APP

The mobile APP called Move Your Knee 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.
No Intervention: control
patients who will be advised to engage in free physical activity (control arm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 30 (T1), 90 (T2), and 180 days (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC);
Time Frame: 30 (T1), 90 (T2), and 180 days (T3)
stiffness and function
30 (T1), 90 (T2), and 180 days (T3)
EUROQoL-5Dimension (EQ-5D).
Time Frame: at 30 (T1), 90 (T2), and 180 days (T3)
quality of life
at 30 (T1), 90 (T2), and 180 days (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania Luigi Vanvitelli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 2, 2025

Primary Completion (Estimated)

May 2, 2026

Study Completion (Estimated)

December 2, 2026

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Actual)

December 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0008758/i-21/03/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Knee Osteoarthristis

Clinical Trials on use the "Move for Knee" APP

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe