Physical Activity Promotion in Osteoarthritis Patients (PIANISSIMO)

Personalized Physical Activity Promotion in Osteoarthritis Patients Using a Smartphone-based Solution

The main purpose of this project is to promote physical activity in patients with osteoarthritis. More specifically, this study aims to test the acceptability of an app to promote physical activity in the target population, and consequently the feasibility of such an approach.

A mobile phone application - namely PIANISSIMO - will be developed specifically for this project. It aims to spread knowledge on the benefits of physical activity and collect data on how this knowledge can induce behavior changes toward a more physically active lifestyle.

The intervention is delivered via the app, which will send daily notifications on physical activity and sedentary behavior, and ask the participants to set their weekly goal (i.e., daily steps). The app will also collect daily steps count and ask the participant to fill in questionnaire on pain once a week.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Behavioral: Physical activity promotion

Detailed Description

Osteoarthritis patients will be recruited from the general population living or working in Luxembourg.

The PIANISSIMO study is a feasibility pilot study. Thus, it is a single-group study, with the participants being their own controls. 150 participants with osteoarthritis will be included. For this study, a mobile application will be developed. It will include self-administered questionnaires, allow physical activity data collection, and deliver the intervention (goal setting, data feedback, notifications to the user and self-completion questionnaires). The intervention will last 6 months, with a further 6-month follow-up.

After signing the explicit consent and data protection notice, participants will encode data and information about individual and chronic pain characteristics, sport history, general health status: Individual questionnaire will include demographic data and general health status. The osteoarthritis pain questionnaire focuses on disease history and evaluation that will include a SF-WOMAC questionnaire. In order to deliver the same intervention for every participant, sham notifications will be send the first week, until the next Sunday for the first goals to be set. First real notification will be send the first Monday after the registration to the study.

The daily step count will be collected in background during the whole study. Then the intervention will be delivered though the phone application: each week, the participant will define a new daily step goal for the following week. Then he/she will receive daily notifications (except Sundays) about physical activity, sedentary behaviour and their consequences on general health and osteoarthritis specifically.

He/she will also be asked to fill in a pain questionnaire once a week. The participant can also spontaneously notify pain at any moment in the same questionnaire. At the end of each month, the participant will be asked about her/his functional status with the WOMAC-SF questionnaire.

At the end of the 6-month intervention, a questionnaire will be sent to the participant to evaluate the application.

During the 6-month follow-up, daily step count will still be collected in background, and pain questionnaires will be sent twice a month, but without any intervention delivered.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mathilde Mura, PhD; Phone Number: +352 26970886; Email: mathilde.mura@lih.lu
• Study Contact Backup: Name: Laetitia Garcia, PhD; Phone Number: +352 26970957; Email: laetitia.garcia@lih.lu

Study Locations

• Luxembourg
  • Strassen, Luxembourg, 1445
    • Recruiting
    • Luxembourg Institute of Health
    • Contact: Laetitia Garcia, Msc; Phone Number: +352 26970957; Email: Laetitia.Garcia@lih.lu
    • Contact: Laurent Malisoux, PhD
    • Contact: Mathilde Mura, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Osteoarthritis patients, living or working in Luxembourg
• Signed informed consent form
• Adequate understanding of one of the study languages (English, French, or German)
• Stated willingness to comply with the study procedure consisting in completing the surveys and the digital physical activity intervention

Exclusion Criteria:

• Rheumatoid arthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Physical activity promotion; The entire population will receive the physical activity promotion intervention, composed of weekly goal setting and daily notification with information about physical activity and sedentary behavior.

Behavioral: Physical activity promotion; The intervention will be delivered through a phone application: each week, the participant will define a new daily step goal for the following week. Then he/she will receive daily notifications (except Sundays) about physical activity, sedentary behavior and their consequences on general health and osteoarthritis specifically. These notifications are designed to promote physical activity in this specific population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weekly number of connections to the application over time	Adherence to the intervention will first be evaluated by the number of connections to the application for any reason.	0 to 6 months
Response rate to the weekly questionnaires over time	Adherence to the intervention will also be evaluated by the the response rate to the questionnaires (pain questionnaires and goal settings).	0 to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of physical activity metrics	evolution of steps/day in response to the physical activity promotion intervention	0 to 6 months
influence of pain on physical activity practice	evolution of daily steps over the week following the pain report	0 to 6 months
influence of physical activity on pain report	record of daily steps over the week before the pain report	0 to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
long-term evolution of daily steps	evolution of steps/day after the end of the physical activity promotion intervention	7 to 12 months

Collaborators and Investigators

• Sponsor: Luxembourg Institute of Health
• Collaborators: Œuvre Nationale de Secours Grande Duchesse Charlotte
• Investigators: Principal Investigator: Laurent Malisoux, PhD, Luxembourg Institute of Health

Publications and helpful links

Helpful Links

• Project page
• Group page

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2025
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: knee; hip; connected devices; physical activity promotion; daily steps
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: 20230213_PIANISSIMO

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