Luxembourg Institute of Health
Strassen, 1445, Luxembourg
Location status: Recruiting
Location contact
Laetitia Garcia, Msc
CONTACT
Laurent Malisoux, PhD
PRINCIPAL_INVESTIGATOR
Mathilde Mura, PhD
SUB_INVESTIGATOR
NCT Number: NCT06385028
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Strassen, 1445, Luxembourg
Location status: Recruiting
Laetitia Garcia, Msc
CONTACT
Laurent Malisoux, PhD
PRINCIPAL_INVESTIGATOR
Mathilde Mura, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
Time frame: 0 to 6 months
evolution of steps/day in response to the physical activity promotion intervention
Time frame: 0 to 6 months
evolution of daily steps over the week following the pain report
Time frame: 0 to 6 months
record of daily steps over the week before the pain report
Time frame: 7 to 12 months
evolution of steps/day after the end of the physical activity promotion intervention
Contact information is provided by the study sponsor or research team.
Laetitia Garcia, PhD
CONTACT
Mathilde Mura, PhD
CONTACT
Luxembourg Institute of Health
Other Gov
Personalized Physical Activity Promotion in Osteoarthritis Patients Using a Smartphone-based Solution
Acronym: PIANISSIMO
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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