Osteo Arthritis Knee and Hipe-cOAchNCT07423858
Predicting The Right Advice at The Right Time in Patients With Hip and Knee OsteoArthritis: the e-cOAch Cross-over.
A study testing Physical Activity program, Sleep program and Weight management program in people with Osteo Arthritis Knee and Hip, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
This study aims to learn how symptoms and daily functioning change over time in people with hip or knee osteoarthritis (OA). The goal is to use this information to build computer models that can predict these changes. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteo Arthritis Knee and Hip
- What is being tested?
- Physical Activity program, Sleep program and Weight management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2025to Feb 2027
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a hip or knee joint that, self-administered through a questionnaire, meets the National
- Institute for Health and Care Excellence clinical criteria for osteoarthritis:
- Aged 45 years or over and;
- Activity-related pain at the joint and;
- Joint morning stiffness that lasts no longer than 30 minutes or no morning stiffness at the joint;
- History of pain at the joint for at least 3 months;
Show all 9Show fewer
- Have access to a smartphone with internet connection and an email address;
- Able to give informed consent and willing to commit to all study evaluation and assessment procedures
- Able to read and understand texts in Dutch at B1 level.
Who cannot join
- Self-reported systemic arthritis (e.g., rheumatoid arthritis, gout) avoid confounding due to overlapping symptoms;
- Scheduled for lower limb joint surgery within the next year or underwent lower limb joint surgery (total hip, total knee) the last year as surgical interventions could affect outcomes and confound the assessment of treatment effects.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Femke Groen, 088 75 588 31, f.groen-4@umcutrecht.nl
Britt van Dongen, MSc, +316 14 33 11 07, artrosecoach@umcutrecht.nl
About this study
Official title: Developing Data Driven Algorithms for Predicting The Right Advice at The Right Time in Patients With Hip and Knee OsteoArthritis: The e-cOAch Cross-over Study
This study aims to learn how symptoms and daily functioning change over time in people with hip or knee osteoarthritis (OA). The goal is to use this information to build computer models that can predict these changes. In the future, these models may help give people with OA the right self-care advice at the right time through a web application called ArtroseCoach.
People with OA will take part in this study for one year. Every two weeks, they will fill in online questionnaires covering various aspects of their health and daily functioning, such as pain, daily activities, and participation in life. During the year, participants will be randomly assigned to one of several self-care programs in the ArtroseCoach web app. These programs focus on physical activity, weight management, or sleep. Each program lasts 12 weeks. At four points during the year (weeks 3, 15, 27, and 39), participants will receive one of these programs or no program at all. No one will receive the same program twice.
The ArtroseCoach web app provides education about OA, lifestyle advice, and tips to support behavior change. The study will help researchers understand which factors are linked to changes in pain and physical functioning over time. This knowledge will be used to improve the ArtroseCoach and other future tools that support people with OA in managing their condition on their own.
Read the detailed description
Objectives of this study include the following:
The primary objective is to develop and evaluate data-driven models to support personalised recommendations regarding the optimal timing of self-management strategies (physical activity promotion, sleep optimization and weight management) in individuals with hip and/or knee OA.
Other objectives with data from this study:
To distinguish subgroups of people with hip/knee OA based on determinants of behavior.
To describe the course and predictive factors of flare-ups in patients with knee and hip osteoarthritis.
To describe how people with knee and/or hip osteoarthritis score on participation, and what factors influence participation.
To describe how people in the e-cOAch cross-over sleep and the association between weight, physical activity, pain and quality of sleep in people with osteoarthritis.
- Conditions
- Osteo Arthritis Knee and Hip
- Being tested
- Physical Activity program, Sleep program, Weight management program, Control: no intervention
- Keywords
- Stepped care, Self-management, Lifestyle behaviours, Movement behaviour, Sleep behaviour, Weight management, Hip and knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity programBehavioural
Aims to increase knowledge and levels of physical activity, and improve muscle strength through three components:
- weekly education on movement, pain, energy management, and recommended moderate to vigorous physical activity levels;
- a graded activity module with baseline measurement (Fitbit Inspire 3 or self-reported physical activity), goal setting, weekly increases of 10% moderate to vigorous physical activity, and reinforcement;
- strength exercises provided via instructional videos, performed twice weekly for 20 minutes.
The physical activity program is developed in line with existing osteoarthritis guidelines and builds on previous research done by our team.
Sleep programBehavioural
Aims to improve insomnia severity through three components, in line with insomnia guidelines:
- weekly education on sleep and sleep hygiene, including recommended behaviours to promote sleep hygiene (e.g., relaxation, consistent routines, environment modification, limiting caffeine and screen time);
- behaviour change support with goal setting, tailored feedback, and prompts to encourage healthier sleep habits.
- mindfulness exercises such as progressive muscle relaxation and meditation.
Weight management programBehavioural
Supports participants in adopting a healthier diet and achieving a healthier weight if needed. Participants can monitor their weight, complete a food frequency questionnaire (FFQ) for personalized feedback, and select food components to focus on. The FFQ represents the Dutch food-based dietary guidelines. Participants receive daily tips and weekly information on healthy eating and weight loss.
Control: no interventionOther
For 12 weeks, participants receive no program. They only fill in questionnaires through the ArtroseCoach web-app.
| Study group | Role | What they receive |
|---|---|---|
| Order of arms 1. Physical activity → Weight management → Sleep → No intervention. | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 2: Physical activity → Weight management → No intervention → Sleep | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 3: Physical activity → Sleep → Weight management → No intervention | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 4: Physical activity → Sleep → No intervention → Weight management | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 5: Physical activity → No intervention → Weight management → Sleep | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 6: Physical activity → No intervention → Sleep → Weight management | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 7: Weight management → Physical activity → Sleep → No intervention | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 8: Weight management → Physical activity → No intervention → Sleep | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 9: Weight management → Sleep → Physical activity → No intervention | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 10: Weight management → Sleep → No intervention → Physical activity | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 11: Weight management → No intervention → Physical activity → Sleep | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 12: Weight management → No intervention → Sleep → Physical activity | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 13: Sleep → Physical activity → Weight management → No intervention | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 14: Sleep → Physical activity → No intervention → Weight management | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 15: Sleep → Weight management → Physical activity → No intervention | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 16: Sleep → Weight management → No intervention → Physical activity | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 17: Sleep → No intervention → Physical activity → Weight management | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
| Order of arms 18: Sleep → No intervention → Weight management → Physical activity | Experimental | This is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention).
Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. Receives: Behavioral: Physical Activity program; Behavioral: Sleep program; Behavioral: Weight management program; Other: Control: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical functioning
Measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS). HOOS includes 40 items and KOOS 42 items in five subdomains of physical functioning. Each item is rated on a 5-point Likert scale. The total scores range from 0 to 100; a higher score represents better physical functioning.
Measured: From baseline until the end of the study at week 52, with assessments every 10 weeks
Secondary outcomes (21)
Numeric Pain Rating Scale
Numeric Pain Rating Scale is a simple scale where participants rate their pain over the past week from 0 (no pain) to 10 (worst pain imaginable). This scale is widely used to track changes in pain intensity over time.
Measured: From baseline until the end of the study at week 52, measured every two weeks.
Participation
The Patient-Reported Outcomes Measurement Information Sys-tem Experience, Short-Form (SF) version 8a. Consists of eight items, each rated on a 5-point Likert scale. Higher scores indicate a lower ability to participate in social roles and activities.
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Stiffness
Measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS). The subscale stiffness consists of two items with a 5-point Likert scale. A higher score represents less stiffness. The HOOS and KOOS also evaluate physical functioning.
Measured: From baseline until the end of the study at week 52, measured every two weeks.
Self-reported active minutes
The Brief Physical Activity Assessment Tool (or in Dutch: Vragenlijst Fysieke Activiteit (VFA)) consists of two items regarding the frequency and duration of Physical activity. The subject can be classified as insufficiently (0-3 score) or sufficiently active (>3 score). Insufficient refers to not meeting the World Health Organization guideline of 150 minutes of moderate-to-vigorous physical activity per week.
Measured: From baseline until the end of the study at week 52, measured every two weeks.
Device measured active minutes
In a random subset (n = 200) of the study population, physical activity will be objectively measured using an activity tracker (Fitbit Inspire 3) worn in participants' home environments for the duration of the study. Device-measured active minutes (Active zone minutes) will be used to assess if someone is meeting the World Health Organization guideline of 150 minutes of moderate-to-vigorous physical activity per week.
Measured: From baseline until the end of the study at week 52, with continuous measures.
Fatigue
A numeric rating scale (NRS-11). One item reports fatigue on a scale from 0 (no fatigue) to 10 (extreme fatigue).
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Job satisfaction
A Numeric Rating Scale (NRS-11). One item reports job satisfaction on a scale from 0 (not satisfied at all) to 10 (completely satisfied).
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Depression and Anxiety
The Hospital Anxiety and Depression Scale. Fourteen items report anxiety and depression symptoms over the past month on a 4-point Likert scale. A higher score indicates more severe symptoms.
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Experienced social support
A numeric rating scale (NRS-11). One item reports experienced social support on a scale from 0 (no support) to 10 (extensive support).
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Kinesiophobia
The Brief Fear Of Moving has six items that report fear on a 5-point Likert Scale from 1 (strongly disagree) to 5 (strongly agree). A higher score indicates greater fear.
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Self-efficacy
A shortened version of the Arthritis Self-Efficacy Scale (ASES), excluding the function subscale. Eleven items that report confidence in managing arthritis-related symptoms with a 5-point Likert scale. A higher score indicates better self-efficacy.
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Insomnia severity
The Insomnia Severity Index has seven items that report insomnia severity on a 5-point Likert scale. A higher score indicates more severe insomnia.
Measured: From baseline until the end of the study at week 52, measured every ten weeks. This outcome is also reported at the start and end of the Sleep program (twelve weeks), the timing of the Sleep program is randomized and can start in week 3, 15, 27, 39.
Pain coping
Pain coping inventory has 33 items that report 6 coping styles on a 4-point Likert scale. The highest number indicates the coping style the participant applies most.
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Weight
Participants are weighed using their own scale. The weight is recorded in kilograms to track changes over time.
Measured: From baseline until the end of the study at week 52, measured every ten weeks. This outcome is also reported at the start and end of the Weight program (twelve weeks), the timing of the Weight program is randomized and can start in week 3, 15, 27, 39.
Physical activity readiness
Physical Activity Readiness Questionnaire has seven yes or no questions about health conditions. If any yes answers are giv-en, medical clearance may be needed before starting activity programs. In this study, the question about joint pain is excluded, since all participants will answer yes.
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Sleep quality
is reported through the Pittsburgh Sleep Quality Index (PSQI). Nineteen items that report sleep quality over the past month on a 4-point Likert scale. A higher score indicates poorer sleep quality.
Measured: From baseline until the end of the study at week 52, measured every ten weeks.
Intention
parameter to change behaviour: "To what extent do you intend to [target behavior]?"
Measured: From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.
Attitude
parameter to change behaviour: "Do you find it important to [target behavior]?"
Measured: From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.
Perceived behavioural control
parameter to change behaviour: "I am confident that if I want to, I can [target behavior]"
Measured: From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.
Engagement
Session start times, session duration, pages visited per session, total number of clicks, reminders that were opened, reminders that led user to start app, interaction with content items, 5-point Likert scale rating for information in the app.
Measured: From baseline until the end of the study in week 52.
Healthcare utilization
One yes or no question that evaluates if participants have re-ceived any care in the past month for their osteoarthritis complaints. If they answered yes, participants can choose between a list of healthcare professionals.
Measured: From baseline until the end of the study in week 52, measured every four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Sep 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (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 Osteo Arthritis Knee and HipStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomized at baseline to one of 18 sequences, each representing a different order of the self-help programs within the ArtroseCoach web application (physical activity, weight management, or sleep) and a control period. The control condition consists of no program for 12 weeks. New programs begin at weeks 3, 15, 27, and 39, ensuring each program is delivered once per participant. Randomization uses a computer-generated allocation sequence. For safety, participants who are extremely underweight (Body Mass Index (BMI) \<17.5) do not receive the weight management program; instead, they have a 12-week no-intervention period and are advised to consult a dietician. Participants who are underweight (BMI \<18.5), extremely overweight (BMI \>30), or who may require medical clearance for the physical activity program (Physical Activity Readiness Questionnaire \>0) are advised to consult a healthcare professional but remain eligible for all sequences.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences Utrecht, Maastricht University, VU University of Amsterdam
- Responsible party
- Principal investigator, Martijn F. Pisters, PhD, PT, UMC Utrecht
- Investigators
- Martijn F. Pisters, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423858
- Sponsor's protocol ID
- NL87119.041.24
- Other IDs
- KICH1.GZ03.21.005
- Acronym
- e-cOAch
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As the data is privacy-sensitive, we publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). All data and documents in the data package will be shared under restrictions descripted below. The data package will contain: the raw data, the study protocol describing the methods and materials, the script to process the data, the scripts leading to tables and figures in the publication, a codebook with explanations on the variable names, and a 'read\_me.txt' file with an overview of files included and their content and use.
Publications
Groen F, de Rooij M, Kloek CJJ, Veenhof C, Klein MCA, Al-Janabi A, van Haeringen ES, Ronteltap A, Paans-Cijs B, van Dongen B, Ginsel DE, Barten DA, Hoogeboom TJ, Pisters MF. Development of Data-Driven Models for Just-in-Time Digital Self-Management Advice to Improve Physical Functioning in Hip and Knee Osteoarthritis: Protocol for the e-cOAch Cross-Over Study. JMIR Res Protoc. 2026 Jun 22;15:e94709. doi: 10.2196/94709.
PubMed 42330486
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Data Driven Algorithms for Predicting The Right Advice at The Right Time in Patients With Hip and Knee OsteoArthritis: The e-cOAch Cross-over Study
- ClinicalTrials.gov ID
- NCT07423858
- Acronym / sponsor ID
- e-cOAch / NL87119.041.24
- Conditions
- Osteo Arthritis Knee and Hip
- Keywords
- Stepped care, Self-management, Lifestyle behaviours, Movement behaviour, Sleep behaviour, Weight management, Hip and knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- University of Applied Sciences Utrecht, Maastricht University, VU University of Amsterdam
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Feb 2026 (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.
This study aims to learn how symptoms and daily functioning change over time in people with hip or knee osteoarthritis (OA). The goal is to use this information to build computer models that can predict these changes. In the future, these models may help give people with OA the right self-care advice at the right time through a web application called ArtroseCoach.
People with OA will take part in this study for one year. Every two weeks, they will fill in online questionnaires covering various aspects of their health and daily functioning, such as pain, daily activities, and participation in life. During the year, participants will be randomly assigned to one of several self-care programs in the ArtroseCoach web app. These programs focus on physical activity, weight management, or sleep. Each program lasts 12 weeks. At four points during the year (weeks 3, 15, 27, and 39), participants will receive one of these programs or no program at all. No one will receive the same program twice.
The ArtroseCoach web app provides education about OA, lifestyle advice, and tips to support behavior change. The study will help researchers understand which factors are linked to changes in pain and physical functioning over time. This knowledge will be used to improve the ArtroseCoach and other future tools that support people with OA in managing their condition on their own.
Detailed description
Objectives of this study include the following:
The primary objective is to develop and evaluate data-driven models to support personalised recommendations regarding the optimal timing of self-management strategies (physical activity promotion, sleep optimization and weight management) in individuals with hip and/or knee OA.
Other objectives with data from this study:
To distinguish subgroups of people with hip/knee OA based on determinants of behavior.
To describe the course and predictive factors of flare-ups in patients with knee and hip osteoarthritis.
To describe how people with knee and/or hip osteoarthritis score on participation, and what factors influence participation.
To describe how people in the e-cOAch cross-over sleep and the association between weight, physical activity, pain and quality of sleep in people with osteoarthritis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 18
- Model description
- Participants are randomized at baseline to one of 18 sequences, each representing a different order of the self-help programs within the ArtroseCoach web application (physical activity, weight management, or sleep) and a control period. The control condition consists of no program for 12 weeks. New programs begin at weeks 3, 15, 27, and 39, ensuring each program is delivered once per participant. Randomization uses a computer-generated allocation sequence. For safety, participants who are extremely underweight (Body Mass Index (BMI) <17.5) do not receive the weight management program; instead, they have a 12-week no-intervention period and are advised to consult a dietician. Participants who are underweight (BMI <18.5), extremely overweight (BMI >30), or who may require medical clearance for the physical activity program (Physical Activity Readiness Questionnaire >0) are advised to consult a healthcare professional but remain eligible for all sequences.
| Arm | Type | Receives |
|---|---|---|
| Order of arms 1. Physical activity → Weight management → Sleep → No intervention. | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 2: Physical activity → Weight management → No intervention → Sleep | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 3: Physical activity → Sleep → Weight management → No intervention | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 4: Physical activity → Sleep → No intervention → Weight management | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 5: Physical activity → No intervention → Weight management → Sleep | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 6: Physical activity → No intervention → Sleep → Weight management | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 7: Weight management → Physical activity → Sleep → No intervention | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 8: Weight management → Physical activity → No intervention → Sleep | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 9: Weight management → Sleep → Physical activity → No intervention | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 10: Weight management → Sleep → No intervention → Physical activity | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 11: Weight management → No intervention → Physical activity → Sleep | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 12: Weight management → No intervention → Sleep → Physical activity | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 13: Sleep → Physical activity → Weight management → No intervention | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 14: Sleep → Physical activity → No intervention → Weight management | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 15: Sleep → Weight management → Physical activity → No intervention | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 16: Sleep → Weight management → No intervention → Physical activity | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 17: Sleep → No intervention → Physical activity → Weight management | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
| Order of arms 18: Sleep → No intervention → Weight management → Physical activity | Experimental | Behavioral: Physical Activity program, Behavioral: Sleep program, Behavioral: Weight management program, Other: Control: no interventionThis is a cross-over study. All participants will receive four interventions in random order: a physical activity module, a sleep module, a weight management module, and a control period (no intervention). Each module lasts 12 weeks. Participants are randomized to one of 18 possible sequences of these four modules. Thus, all participants will eventually receive all interventions, but the order will differ. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have a hip or knee joint that, self-administered through a questionnaire, meets the National
- History of pain at the joint for at least 3 months;
- Have access to a smartphone with internet connection and an email address;
- Able to give informed consent and willing to commit to all study evaluation and assessment procedures
- Able to read and understand texts in Dutch at B1 level.
Key exclusion criteria (2 listed)
- Self-reported systemic arthritis (e.g., rheumatoid arthritis, gout) avoid confounding due to overlapping symptoms;
- Scheduled for lower limb joint surgery within the next year or underwent lower limb joint surgery (total hip, total knee) the last year as surgical interventions could affect outcomes and confound the assessment of treatment effects.
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 programAims to increase knowledge and levels of physical activity, and improve muscle strength through three components: 1. weekly education on movement, pain, energy management, and recommended moderate to vigorous physical activity levels; 2. a graded activity module with baseline measurement (Fitbit Inspire 3 or self-reported physical activity), goal setting, weekly increases of 10% moderate to vigorous physical activity, and reinforcement; 3. strength exercises provided via instructional videos, performed twice weekly for 20 minutes. The physical activity program is developed in line with existing osteoarthritis guidelines and builds on previous research done by our team. | Behavioural | Order of arms 1. Physical activity → Weight management → Sleep → No intervention., Order of arms 10: Weight management → Sleep → No intervention → Physical activity, Order of arms 11: Weight management → No intervention → Physical activity → Sleep, Order of arms 12: Weight management → No intervention → Sleep → Physical activity, Order of arms 13: Sleep → Physical activity → Weight management → No intervention, Order of arms 14: Sleep → Physical activity → No intervention → Weight management, Order of arms 15: Sleep → Weight management → Physical activity → No intervention, Order of arms 16: Sleep → Weight management → No intervention → Physical activity, Order of arms 17: Sleep → No intervention → Physical activity → Weight management, Order of arms 18: Sleep → No intervention → Weight management → Physical activity, Order of arms 2: Physical activity → Weight management → No intervention → Sleep, Order of arms 3: Physical activity → Sleep → Weight management → No intervention, Order of arms 4: Physical activity → Sleep → No intervention → Weight management, Order of arms 5: Physical activity → No intervention → Weight management → Sleep, Order of arms 6: Physical activity → No intervention → Sleep → Weight management, Order of arms 7: Weight management → Physical activity → Sleep → No intervention, Order of arms 8: Weight management → Physical activity → No intervention → Sleep, Order of arms 9: Weight management → Sleep → Physical activity → No intervention |
| Sleep programAims to improve insomnia severity through three components, in line with insomnia guidelines: 1. weekly education on sleep and sleep hygiene, including recommended behaviours to promote sleep hygiene (e.g., relaxation, consistent routines, environment modification, limiting caffeine and screen time); 2. behaviour change support with goal setting, tailored feedback, and prompts to encourage healthier sleep habits. 3. mindfulness exercises such as progressive muscle relaxation and meditation. | Behavioural | Order of arms 1. Physical activity → Weight management → Sleep → No intervention., Order of arms 10: Weight management → Sleep → No intervention → Physical activity, Order of arms 11: Weight management → No intervention → Physical activity → Sleep, Order of arms 12: Weight management → No intervention → Sleep → Physical activity, Order of arms 13: Sleep → Physical activity → Weight management → No intervention, Order of arms 14: Sleep → Physical activity → No intervention → Weight management, Order of arms 15: Sleep → Weight management → Physical activity → No intervention, Order of arms 16: Sleep → Weight management → No intervention → Physical activity, Order of arms 17: Sleep → No intervention → Physical activity → Weight management, Order of arms 18: Sleep → No intervention → Weight management → Physical activity, Order of arms 2: Physical activity → Weight management → No intervention → Sleep, Order of arms 3: Physical activity → Sleep → Weight management → No intervention, Order of arms 4: Physical activity → Sleep → No intervention → Weight management, Order of arms 5: Physical activity → No intervention → Weight management → Sleep, Order of arms 6: Physical activity → No intervention → Sleep → Weight management, Order of arms 7: Weight management → Physical activity → Sleep → No intervention, Order of arms 8: Weight management → Physical activity → No intervention → Sleep, Order of arms 9: Weight management → Sleep → Physical activity → No intervention |
| Weight management programSupports participants in adopting a healthier diet and achieving a healthier weight if needed. Participants can monitor their weight, complete a food frequency questionnaire (FFQ) for personalized feedback, and select food components to focus on. The FFQ represents the Dutch food-based dietary guidelines. Participants receive daily tips and weekly information on healthy eating and weight loss. | Behavioural | Order of arms 1. Physical activity → Weight management → Sleep → No intervention., Order of arms 10: Weight management → Sleep → No intervention → Physical activity, Order of arms 11: Weight management → No intervention → Physical activity → Sleep, Order of arms 12: Weight management → No intervention → Sleep → Physical activity, Order of arms 13: Sleep → Physical activity → Weight management → No intervention, Order of arms 14: Sleep → Physical activity → No intervention → Weight management, Order of arms 15: Sleep → Weight management → Physical activity → No intervention, Order of arms 16: Sleep → Weight management → No intervention → Physical activity, Order of arms 17: Sleep → No intervention → Physical activity → Weight management, Order of arms 18: Sleep → No intervention → Weight management → Physical activity, Order of arms 2: Physical activity → Weight management → No intervention → Sleep, Order of arms 3: Physical activity → Sleep → Weight management → No intervention, Order of arms 4: Physical activity → Sleep → No intervention → Weight management, Order of arms 5: Physical activity → No intervention → Weight management → Sleep, Order of arms 6: Physical activity → No intervention → Sleep → Weight management, Order of arms 7: Weight management → Physical activity → Sleep → No intervention, Order of arms 8: Weight management → Physical activity → No intervention → Sleep, Order of arms 9: Weight management → Sleep → Physical activity → No intervention |
| Control: no interventionFor 12 weeks, participants receive no program. They only fill in questionnaires through the ArtroseCoach web-app. | Other | Order of arms 1. Physical activity → Weight management → Sleep → No intervention., Order of arms 10: Weight management → Sleep → No intervention → Physical activity, Order of arms 11: Weight management → No intervention → Physical activity → Sleep, Order of arms 12: Weight management → No intervention → Sleep → Physical activity, Order of arms 13: Sleep → Physical activity → Weight management → No intervention, Order of arms 14: Sleep → Physical activity → No intervention → Weight management, Order of arms 15: Sleep → Weight management → Physical activity → No intervention, Order of arms 16: Sleep → Weight management → No intervention → Physical activity, Order of arms 17: Sleep → No intervention → Physical activity → Weight management, Order of arms 18: Sleep → No intervention → Weight management → Physical activity, Order of arms 2: Physical activity → Weight management → No intervention → Sleep, Order of arms 3: Physical activity → Sleep → Weight management → No intervention, Order of arms 4: Physical activity → Sleep → No intervention → Weight management, Order of arms 5: Physical activity → No intervention → Weight management → Sleep, Order of arms 6: Physical activity → No intervention → Sleep → Weight management, Order of arms 7: Weight management → Physical activity → Sleep → No intervention, Order of arms 8: Weight management → Physical activity → No intervention → Sleep, Order of arms 9: Weight management → Sleep → Physical activity → No intervention |
Primary outcome
Physical functioning
Time frame: From baseline until the end of the study at week 52, with assessments every 10 weeks
Measured using the Hip disability and Osteoarthritis Outcome Score (HOOS) or Knee injury and Osteoarthritis Outcome Score (KOOS). HOOS includes 40 items and KOOS 42 items in five subdomains of physical functioning. Each item is rated on a 5-point Likert scale. The total scores range from 0 to 100; a higher score represents better physical functioning.
21 secondary outcomes
Numeric Pain Rating Scale
Time frame: From baseline until the end of the study at week 52, measured every two weeks.
Participation
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Stiffness
Time frame: From baseline until the end of the study at week 52, measured every two weeks.
Self-reported active minutes
Time frame: From baseline until the end of the study at week 52, measured every two weeks.
Device measured active minutes
Time frame: From baseline until the end of the study at week 52, with continuous measures.
Fatigue
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Job satisfaction
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Depression and Anxiety
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Experienced social support
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Kinesiophobia
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Self-efficacy
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Insomnia severity
Time frame: From baseline until the end of the study at week 52, measured every ten weeks. This outcome is also reported at the start and end of the Sleep program (twelve weeks), the timing of the Sleep program is randomized and can start in week 3, 15, 27, 39.
Pain coping
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Weight
Time frame: From baseline until the end of the study at week 52, measured every ten weeks. This outcome is also reported at the start and end of the Weight program (twelve weeks), the timing of the Weight program is randomized and can start in week 3, 15, 27, 39.
Physical activity readiness
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Sleep quality
Time frame: From baseline until the end of the study at week 52, measured every ten weeks.
Intention
Time frame: From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.
Attitude
Time frame: From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.
Perceived behavioural control
Time frame: From baseline until the end of the study, measured prior to any of the programs (sleep, weight, physical activity). The timing of the programs is randomized and can start in week 3, 15, 27, 39.
Engagement
Time frame: From baseline until the end of the study in week 52.
Healthcare utilization
Time frame: From baseline until the end of the study in week 52, measured every four weeks.
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 20 Feb 2026.
- Derived from this study: PubMed 42330486Groen F, de Rooij M, Kloek CJJ, Veenhof C, Klein MCA, Al-Janabi A, van Haeringen ES, Ronteltap A, Paans-Cijs B, van Dongen B, Ginsel DE, Barten DA, Hoogeboom TJ, Pisters MF. Development of Data-Driven Models for Just-in-Time Digital Self-Management Advice to Improve Physical Functioning in Hip and Knee Osteoarthritis: Protocol for the e-cOAch Cross-Over Study. JMIR Res Protoc. 2026 Jun 22;15:e94709. doi: 10.2196/94709.
- Project web pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. As the data is privacy-sensitive, we publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). All data and documents in the data package will be shared under restrictions descripted below. The data package will contain: the raw data, the study protocol describing the methods and materials, the script to process the data, the scripts leading to tables and figures in the publication, a codebook with explanations on the variable names, and a 'read_me.txt' file with an overview of files included and their content and use.
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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.
Martijn F. Pisters, PhD principal investigator
UMC Utrecht
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 program, Sleep program and Weight management program in people with Osteo Arthritis Knee and Hip, run by UMC Utrecht at 1 site in Netherlands.
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 9 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 20 Feb 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 Netherlands. 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?
Contact Femke Groen, MSc (+31652783039, f.groen-4@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical functioning (time frame: From baseline until the end of the study at week 52, with assessments every 10 weeks). 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 NCT07423858, 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 20 Feb 2026.