NCT06385028

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Feb 2025Jul 2026

First Submitted

Initial submission to the registry

April 23, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

February 13, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

12 months

First QC Date

April 23, 2024

Last Update Submit

March 4, 2025

Conditions

Osteoarthritis

Keywords

physical activity promotiondaily stepsconnected deviceskneehip

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Evolution of physical activity metrics

    0 to 6 months

  • influence of pain on physical activity practice

    0 to 6 months

  • influence of physical activity on pain report

    0 to 6 months

Other Outcomes (1)

  • long-term evolution of daily steps

    7 to 12 months

Study Arms (1)

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.

Behavioral: Physical activity promotion

Interventions

Physical activity promotionBEHAVIORAL

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.

Physical activity promotion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luxembourg Institute of Health

Strassen, 1445, Luxembourg

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41351123DERIVED

Related Links

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Laurent Malisoux, PhD

    Luxembourg Institute of Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilde Mura, PhD

CONTACT

+352 26970886mathilde.mura@lih.lu

Laetitia Garcia, PhD

CONTACT

+352 26970957laetitia.garcia@lih.lu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Pilot feasibility study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Group leader

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 25, 2024

Study Start

February 13, 2025

Primary Completion

January 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

LU(1)