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NCT Number: NCT06385028

Physical Activity Promotion in Osteoarthritis Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luxembourg Institute of Health

Strassen, 1445, Luxembourg

Location status: Recruiting

Location contact

Laetitia Garcia, Msc

CONTACT

[email protected]

+352 26970957

Laurent Malisoux, PhD

PRINCIPAL_INVESTIGATOR

Mathilde Mura, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Activity Promotion

Behavioral

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.

Primary outcomes

  1. Weekly number of connections to the application over time

    Time frame: 0 to 6 months

    Adherence to the intervention will first be evaluated by the number of connections to the application for any reason.

  2. Response rate to the weekly questionnaires over time

    Time frame: 0 to 6 months

    Adherence to the intervention will also be evaluated by the the response rate to the questionnaires (pain questionnaires and goal settings).

Secondary outcomes

  1. Evolution of physical activity metrics

    Time frame: 0 to 6 months

    evolution of steps/day in response to the physical activity promotion intervention

  2. influence of pain on physical activity practice

    Time frame: 0 to 6 months

    evolution of daily steps over the week following the pain report

  3. influence of physical activity on pain report

    Time frame: 0 to 6 months

    record of daily steps over the week before the pain report

Other outcomes

  1. long-term evolution of daily steps

    Time frame: 7 to 12 months

    evolution of steps/day after the end of the physical activity promotion intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Laetitia Garcia, PhD

CONTACT

[email protected]

+352 26970957

Mathilde Mura, PhD

CONTACT

[email protected]

+352 26970886

Sponsors and collaborators

Lead sponsor

Luxembourg Institute of Health

Other Gov

Collaborators

  • Œuvre Nationale de Secours Grande Duchesse Charlotte

Registry information

Official study title

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

Acronym: PIANISSIMO

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2024
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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