Mobile App Use for Physical Activity in Knee Osteoarthritis

NCT06721208 | Not Yet Recruiting DMC

• 1 other identifier: 0008758/i-21/03/2024
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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

Conditions

Knee Osteoarthristis

Keywords

knee osteoarthiritis; physical activity; functioning; pain; digital health; mobile application

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory (BPI) and its two indexes (severity and interference indexes; BPI-SI, BPI-II)

  multidimensional pain evaluation

  at 30 (T1), 90 (T2), and 180 days (T3)

Secondary Outcomes (2)

• 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)

Study Arms (2)

intervention

EXPERIMENTAL

\- patients who will use the "Move for Knee" APP (intervention arm);

Behavioral: use the "Move for Knee" APP

control

NO INTERVENTION

patients who will be advised to engage in free physical activity (control arm).

Interventions

use the "Move for Knee" APP BEHAVIORAL

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.

intervention

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychiatric disorders that could potentially invalidate informed consent
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Related Publications (6)

• Li E, Tan J, Xu K, Pan Y, Xu P. Global burden and socioeconomic impact of knee osteoarthritis: a comprehensive analysis. Front Med (Lausanne). 2024 May 16;11:1323091. doi: 10.3389/fmed.2024.1323091. eCollection 2024.

  PMID: 38818397 BACKGROUND

• Iolascon G, Migliore A, Beretta G, Bernetti A, Bortolotti R, Celano A, Giarratano A, Marinangeli F, Momoli A, Sebastiani GD, Tomasini A, Tonolo S, Madotto F, Di Martino A, Natoli S. Pain Management in Knee Osteoarthritis: Insights from an Exploratory Online Survey of Italian Patients and Physicians. Healthcare (Basel). 2024 Oct 18;12(20):2077. doi: 10.3390/healthcare12202077.

  PMID: 39451492 BACKGROUND

• Geng R, Li J, Yu C, Zhang C, Chen F, Chen J, Ni H, Wang J, Kang K, Wei Z, Xu Y, Jin T. Knee osteoarthritis: Current status and research progress in treatment (Review). Exp Ther Med. 2023 Aug 25;26(4):481. doi: 10.3892/etm.2023.12180. eCollection 2023 Oct.

  PMID: 37745043 BACKGROUND

• Lee J, Chang RW, Ehrlich-Jones L, Kwoh CK, Nevitt M, Semanik PA, Sharma L, Sohn MW, Song J, Dunlop DD. Sedentary behavior and physical function: objective evidence from the Osteoarthritis Initiative. Arthritis Care Res (Hoboken). 2015 Mar;67(3):366-73. doi: 10.1002/acr.22432.

  PMID: 25155652 BACKGROUND

• Zmerly H, Milanese C, El Ghoch M, Itani L, Tannir H, Kreidieh D, Yumuk V, Pellegrini M. Personalized Physical Activity Programs for the Management of Knee Osteoarthritis in Individuals with Obesity: A Patient-Centered Approach. Diseases. 2023 Dec 14;11(4):182. doi: 10.3390/diseases11040182.

  PMID: 38131988 BACKGROUND

• Scopaz KA, Piva SR, Wisniewski S, Fitzgerald GK. Relationships of fear, anxiety, and depression with physical function in patients with knee osteoarthritis. Arch Phys Med Rehabil. 2009 Nov;90(11):1866-73. doi: 10.1016/j.apmr.2009.06.012.

  PMID: 19887210 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Pain

Condition Hierarchy (Ancestors)

Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Erika Martinelli, prof

CONTACT

+39 081 5664009; comitato.etico@policliniconapoli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: May 2, 2025
• Primary Completion: May 2, 2026
• Study Completion (Estimated): December 2, 2026
• Last Updated: February 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share