Knee OsteoarthritisNCT07875647
Person-Centred Digital Rehabilitation for Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Physical Activity Behaviour, run by Mälardalen University at 1 site in Sweden.
Trial summary
This study aims to improve our understanding of how people with knee osteoarthritis think about, regulate, and adapt their physical activity while participating in Joint Academy's digital osteoarthritis programme for knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Physical Activity Behaviour
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2026to 30 Sep 2027
- Phase
- Observational
- 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
Study population: Patients with knee osteoarthritis enrolled in Joint Academy's rehabilitation programme in Sweden.
Who may be able to join
- The study will include adults with a confirmed diagnosis of knee osteoarthritis who are enrolled in Joint Academy's digital rehabilitation programme. Inclusion and exclusion criteria follow Joint Academy's established clinical routines, which align with those used in the Swedish national Better Management of Patients with Osteoarthritis (BOA) programme. Participants must meet the standard clinical criteria for knee osteoarthritis and must not be assessed as requiring a physical examination or further diagnostic investigation. Because the intervention is delivered through a mobile application, participants must have access to a smartphone or tablet with internet connectivity and be comfortable using digital technology to follow the exercise programme, communicate with physiotherapists, and access educational materials.
Who cannot join
- Participants meeting any of the following exclusion criteria applied by Joint Academy's digital osteoarthritis programme will not be eligible for inclusion:
- Another serious primary condition is judged to be the main cause of the participant's symptoms (e.g., cancer, inflammatory joint disease, neurological disease, or persistent disability following hip fracture).
- Physical exercise is contraindicated. Another health condition currently causes more severe symptoms than the knee condition for which treatment is sought (e.g., chronic widespread pain or fibromyalgia).
- Age below 18 years. Inability to understand or communicate in Swedish or English.
- In addition, individuals will be excluded from the research project if they:
- Have cognitive or intellectual impairments that prevent the provision of informed consent.
- Have disabilities or medical conditions that substantially limit independent performance of daily activities.
- Have speech, visual, or hearing impairments that cannot be adequately compensated for by assistive devices and therefore prevent participation in data collection or, where applicable, qualitative interviews.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Person-centred and Information-driven Physiotherapy for Sustainable Behaviour Change in a Digital Osteoarthritis Rehabilitation
This study aims to improve our understanding of how people with knee osteoarthritis think about, regulate, and adapt their physical activity while participating in Joint Academy's digital osteoarthritis programme for knee osteoarthritis. The study will investigate how understanding of the regulation of physical activity, psychological factors, and patterns of daily activity are related to participation in rehabilitation and changes in physical function over time. By gaining a better understanding of how people experience and manage physical activity in the context of knee osteoarthritis, we hope to improve the knee osteoarthritis programme and support rehabilitation that is better tailored to individual needs.
- Conditions
- Knee Osteoarthritis, Physical Activity Behaviour
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Specific Functional Scale
The Patient-Specific Functional Scale (PSFS) is a patient-reported outcome measure in which individuals identify activities that are important to them but are limited by their condition. Each activity is rated on a scale from 0 to 10, where 0 indicates inability to perform the activity and 10 indicates the ability to perform the activity at the pre-injury or pre-condition level. The PSFS is commonly used to monitor changes in function over time.
Measured: From enrollment to the end of the treatment at 12 weeks
KOOS-12 Function subscale
The functional subscale of the 12-items Knee injury and Osteoarthritis Outcome Score (KOOS-12) assesses knee-related physical function. Higher scores indicate better status. The baseline score will be used as the primary functional outcome in cross sectional analysis of activity patterns and psychological factors.
Measured: From enrollment to the end of the treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completion30 Sep 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 Knee 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mälardalen University
- Sponsor type
- University, hospital or other
- Collaborators
- Joint Academy
- Responsible party
- Sponsor
- Investigators
- Petra von Heideken Wågert, Prof., Study chair, Department of Health Sciences, Innovation and Design, Mälardalen University, Västerås, SwedenJohan Söderberg, PhD Student, Principal investigator, Department of Health Sciences, Innovation and Design, Mälardalen University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875647
- Sponsor's protocol ID
- 2026-00654-01
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to the sensitive nature of the health data and restrictions related to ethical approval, data protection requirements and data sharing agreements. Study material that do not contain individual-level participant data, such as the study protocol, statistical analysis plan and aggregated results may be made available where appropriate.
Publications
Soderberg J, Holmstrom IK, Ehn M, Florin U, Von Heideken Wagert P. Ways of understanding the regulation of physical activity among persons with knee osteoarthritis in digital rehabilitation: a phenomenographic study. BMJ Open. 2026 Sep 23;16(9):e124247. doi: 10.1136/bmjopen-2026-124247.
PubMed 42778241
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Person-centred and Information-driven Physiotherapy for Sustainable Behaviour Change in a Digital Osteoarthritis Rehabilitation
- ClinicalTrials.gov ID
- NCT07875647
- Acronym / sponsor ID
- 2026-00654-01
- Conditions
- Knee Osteoarthritis, Physical Activity Behaviour
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mälardalen UniversityUniversity, hospital or other
- Collaborators
- Joint Academy
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 15 Oct 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 improve our understanding of how people with knee osteoarthritis think about, regulate, and adapt their physical activity while participating in Joint Academy's digital osteoarthritis programme for knee osteoarthritis. The study will investigate how understanding of the regulation of physical activity, psychological factors, and patterns of daily activity are related to participation in rehabilitation and changes in physical function over time. By gaining a better understanding of how people experience and manage physical activity in the context of knee osteoarthritis, we hope to improve the knee osteoarthritis programme and support rehabilitation that is better tailored to individual needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis enrolled in Joint Academy's rehabilitation programme in Sweden.
Key inclusion criteria (1 listed)
- The study will include adults with a confirmed diagnosis of knee osteoarthritis who are enrolled in Joint Academy's digital rehabilitation programme. Inclusion and exclusion criteria follow Joint Academy's established clinical routines, which align with those used in the Swedish national Better Management of Patients with Osteoarthritis (BOA) programme. Participants must meet the standard clinical criteria for knee osteoarthritis and must not be assessed as requiring a physical examination or further diagnostic investigation. Because the intervention is delivered through a mobile application, participants must have access to a smartphone or tablet with internet connectivity and be comfortable using digital technology to follow the exercise programme, communicate with physiotherapists, and access educational materials.
Key exclusion criteria (8 listed)
- Participants meeting any of the following exclusion criteria applied by Joint Academy's digital osteoarthritis programme will not be eligible for inclusion:
- Another serious primary condition is judged to be the main cause of the participant's symptoms (e.g., cancer, inflammatory joint disease, neurological disease, or persistent disability following hip fracture).
- Physical exercise is contraindicated. Another health condition currently causes more severe symptoms than the knee condition for which treatment is sought (e.g., chronic widespread pain or fibromyalgia).
- Age below 18 years. Inability to understand or communicate in Swedish or English.
- Have cognitive or intellectual impairments that prevent the provision of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Specific Functional Scale
Time frame: From enrollment to the end of the treatment at 12 weeks
The Patient-Specific Functional Scale (PSFS) is a patient-reported outcome measure in which individuals identify activities that are important to them but are limited by their condition. Each activity is rated on a scale from 0 to 10, where 0 indicates inability to perform the activity and 10 indicates the ability to perform the activity at the pre-injury or pre-condition level. The PSFS is commonly used to monitor changes in function over time.
KOOS-12 Function subscale
Time frame: From enrollment to the end of the treatment at 12 weeks.
The functional subscale of the 12-items Knee injury and Osteoarthritis Outcome Score (KOOS-12) assesses knee-related physical function. Higher scores indicate better status. The baseline score will be used as the primary functional outcome in cross sectional analysis of activity patterns and psychological factors.
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 15 Oct 2026.
- Background: PubMed 42778241Soderberg J, Holmstrom IK, Ehn M, Florin U, Von Heideken Wagert P. Ways of understanding the regulation of physical activity among persons with knee osteoarthritis in digital rehabilitation: a phenomenographic study. BMJ Open. 2026 Sep 23;16(9):e124247. doi: 10.1136/bmjopen-2026-124247.
- Project page at Mälardalen UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to the sensitive nature of the health data and restrictions related to ethical approval, data protection requirements and data sharing agreements. Study material that do not contain individual-level participant data, such as the study protocol, statistical analysis plan and aggregated results may be made available where appropriate.
Related trials for Knee Osteoarthritis
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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.
Petra von Heideken Wågert, Prof. study chair
Department of Health Sciences, Innovation and Design, Mälardalen University, Västerås, Sweden
Johan Söderberg, PhD Student principal investigator
Department of Health Sciences, Innovation and Design, Mälardalen University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Physical Activity Behaviour, run by Mälardalen University at 1 site in Sweden.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 15 Oct 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 Sweden. 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 Johan H Söderberg, PhD student (+46 21 480 69 17, johan.soderberg@mdu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Specific Functional Scale (time frame: From enrollment to the end of the treatment at 12 weeks). 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 NCT07875647, 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 15 Oct 2026.