OsteoarthritisPIANISSIMONCT06385028
Physical Activity Promotion in Osteoarthritis Patients
A study testing Physical activity promotion in people with Osteoarthritis, run by Luxembourg Institute of Health at 1 site in Luxembourg.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Physical activity promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteLuxembourg
- Study dates
- 13 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Physical activity promotion
- Keywords
- physical activity promotion, daily steps, connected devices, knee, hip
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity promotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity promotion | Experimental | 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. Receives: Behavioral: Physical activity promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 0 to 6 months
Secondary outcomes (3)
Evolution of physical activity metrics
evolution of steps/day in response to the physical activity promotion intervention
Measured: 0 to 6 months
influence of pain on physical activity practice
evolution of daily steps over the week following the pain report
Measured: 0 to 6 months
influence of physical activity on pain report
record of daily steps over the week before the pain report
Measured: 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start13 Feb 2025
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot feasibility study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Œuvre Nationale de Secours Grande Duchesse Charlotte
- Responsible party
- Principal investigator, Laurent Malisoux, PhD, Luxembourg Institute of Health
- Investigators
- Laurent Malisoux, PhD, Principal investigator, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385028
- Sponsor's protocol ID
- 20230213_PIANISSIMO
- Acronym
- PIANISSIMO
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mura M, Portugal B, Mouton C, Grimm B, Seil R, Malisoux L. An app-based physical activity intervention for people with hip and knee osteoarthritis: protocol for the PIANISSIMO feasibility study. Pilot Feasibility Stud. 2025 Dec 5;12(1):5. doi: 10.1186/s40814-025-01744-z.
PubMed 41351123
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Physical Activity Promotion in Osteoarthritis Patients Using a Smartphone-based Solution
- ClinicalTrials.gov ID
- NCT06385028
- Acronym / sponsor ID
- PIANISSIMO / 20230213_PIANISSIMO
- Conditions
- Osteoarthritis
- Keywords
- physical activity promotion, daily steps, connected devices, knee, hip
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Œuvre Nationale de Secours Grande Duchesse Charlotte
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot feasibility study
| Arm | Type | Receives |
|---|---|---|
| Physical activity promotion | Experimental | Behavioral: Physical activity promotionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity promotionThe 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. | Behavioural | Physical activity promotion |
Primary outcome
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.
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).
3 secondary outcomes
Evolution of physical activity metrics
Time frame: 0 to 6 months
influence of pain on physical activity practice
Time frame: 0 to 6 months
influence of physical activity on pain report
Time frame: 0 to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Derived from this study: PubMed 41351123Mura M, Portugal B, Mouton C, Grimm B, Seil R, Malisoux L. An app-based physical activity intervention for people with hip and knee osteoarthritis: protocol for the PIANISSIMO feasibility study. Pilot Feasibility Stud. 2025 Dec 5;12(1):5. doi: 10.1186/s40814-025-01744-z.
- Project pageLink provided by the sponsor.
- Group pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Malisoux, PhD principal investigator
Luxembourg Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity promotion in people with Osteoarthritis, run by Luxembourg Institute of Health at 1 site in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly number of connections to the application over time (time frame: 0 to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06385028, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.