Knee OsteoarthritisNCT03125954
Changes in Physical Inactivity in Patients with Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
This is an objective cohort study using objective recording of physical activity (accelerometry) during and after the GLAiD intervention to investigate if a sedentary behavior change by participating in an 6-week physiotherapy-led exercise and education program (GLAiD) occurs. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- standardized exercise treatment for knee OA in Denmark (GLAiD)
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 8 May 2017to 29 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with knee osteoarthritis refered to the GLAiD program
Who may be able to join
- ≥40 years
- Diagnosed with knee OA
- Willing and able to complete study visits and procedures
- Owner of a smartphone or tablet
- Eligible for participation in the GLAID treatment
- Speaks, reads and writes Danish language
Who cannot join
- Any condition, which in the opinion of the Investigator, would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Changes in Physical Inactivity Secondary to Exercise Therapy in Patients with Knee Osteoarthritis: a Prospective Cohort Study
This is an objective cohort study using objective recording of physical activity (accelerometry) during and after the GLAiD intervention to investigate if a sedentary behavior change by participating in an 6-week physiotherapy-led exercise and education program (GLAiD) occurs. The GLAiD intervention is an education and exercise based intervention aiming at decreasing pain and improving function in patients with knee osteoarthritis.
The primary outcome is change in objective recorded physical activity between baseline and follow-up.
- Conditions
- Knee Osteoarthritis
- Being tested
- standardized exercise treatment for knee OA in Denmark (GLAiD)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized exercise treatment for knee OA in Denmark (GLAiD)Other
objective measurement of physical activity before, during af after the GLAiD intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Objectively measured physical activity
accelerometer recorded physical activity
Measured: 6 weeks
Secondary outcomes (1)
Knee Injury and Osteoarthritis Outcome Score(KOOS)
KOOS questionnaire
Measured: baseline (day 1) and follow-up (after 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start8 May 2017
- Primary completion29 Jul 2018
- Study completion29 Jul 2018
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Henriksen, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125954
- Sponsor's protocol ID
- InactivityOAIII
- Status last verified
- Dec 2018
- First submitted
- 21 Mar 2017
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bartholdy C, Skou ST, Bliddal H, Henriksen M. Changes in physical inactivity during supervised educational and exercise therapy in patients with knee osteoarthritis: A prospective cohort study. Knee. 2020 Dec;27(6):1848-1856. doi: 10.1016/j.knee.2020.09.007. Epub 2020 Nov 13.
PubMed 33197825
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Physical Inactivity Secondary to Exercise Therapy in Patients with Knee Osteoarthritis: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03125954
- Acronym / sponsor ID
- InactivityOAIII
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- 29 Jul 2018 (actual)
- Study completion
- 29 Jul 2018 (actual)
- First posted
- 24 Apr 2017 (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 is an objective cohort study using objective recording of physical activity (accelerometry) during and after the GLAiD intervention to investigate if a sedentary behavior change by participating in an 6-week physiotherapy-led exercise and education program (GLAiD) occurs. The GLAiD intervention is an education and exercise based intervention aiming at decreasing pain and improving function in patients with knee osteoarthritis.
The primary outcome is change in objective recorded physical activity between baseline and follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with knee osteoarthritis refered to the GLAiD program
Key inclusion criteria (6 listed)
- ≥40 years
- Diagnosed with knee OA
- Willing and able to complete study visits and procedures
- Owner of a smartphone or tablet
- Eligible for participation in the GLAID treatment
Key exclusion criteria (1 listed)
- Any condition, which in the opinion of the Investigator, would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.
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 |
|---|---|---|
| standardized exercise treatment for knee OA in Denmark (GLAiD)objective measurement of physical activity before, during af after the GLAiD intervention | Other | – |
Primary outcome
Objectively measured physical activity
Time frame: 6 weeks
accelerometer recorded physical activity
1 secondary outcome
Knee Injury and Osteoarthritis Outcome Score(KOOS)
Time frame: baseline (day 1) and follow-up (after 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 33197825Bartholdy C, Skou ST, Bliddal H, Henriksen M. Changes in physical inactivity during supervised educational and exercise therapy in patients with knee osteoarthritis: A prospective cohort study. Knee. 2020 Dec;27(6):1848-1856. doi: 10.1016/j.knee.2020.09.007. Epub 2020 Nov 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Frederiksberg University Hospital at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 27 Feb 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objectively measured physical activity (time frame: 6 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 NCT03125954, 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 27 Feb 2025.