An interventional study of Physical activity promotion in Osteoarthritis, sponsored by Luxembourg Institute of Health. Active, not recruiting at 1 site in Luxembourg. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Luxembourg Institute of Health · Not applicable, Interventional, and Prevention
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.
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 150 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Luxembourg Institute of Health is the lead sponsor of 28 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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).
Time frame: 0 to 6 months
Evolution of physical activity metrics
evolution of steps/day in response to the physical activity promotion intervention
Time frame: 0 to 6 months
influence of pain on physical activity practice
evolution of daily steps over the week following the pain report
Time frame: 0 to 6 months
influence of physical activity on pain report
record of daily steps over the week before the pain report
Time frame: 0 to 6 months
long-term evolution of daily steps
evolution of steps/day after the end of the physical activity promotion intervention
Time frame: 7 to 12 months
Plan to share: No
Ran from Feb 2025 to primary completion in Jun 2026, 16 months.
Of 578 non-industry interventional studies with no phase under Osteoarthritis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 52. This study's 16 months is below that.
Counting every sponsor, half of 713 studies reached it within 29 months; a quarter within 11 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Luxembourg Institute of Health