Osteoarthritis, KneeNCT02905747
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
A study testing Medical Exercise Therapy in people with Osteoarthritis, Knee, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of the project is to investigate effects of medical exercise therapy (MET) on patients with knee osteoarthritis. MET is a common physical therapy intervention, and the project aim to strengthen the evidence of this intervention. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Medical Exercise Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2016to 1 Dec 2018
- Phase
- Interventional
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- x-ray verified knee osteoarthritis (Kellegren \& Lawrence grade I-III)
- Loss of function and withstanding pain >3 months
Who cannot join
- physical therapy treatment during the last 3 months
- knee injury
- inflammatory arthritis
- symptoms from the hip joints greater than the knee pain
- planned knee surgery the next 6 months
- heart and lung disorders or other health issues affecting the ability to complete the intervention
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the project is to investigate effects of medical exercise therapy (MET) on patients with knee osteoarthritis. MET is a common physical therapy intervention, and the project aim to strengthen the evidence of this intervention. An experimental cohort design is chosen, and 20 participants will be followed for 6 months. Assessments will be clinical tests, questionnaires and accelerometer measurements before, during, and after a 3 month period of exercise (3 days per week) with a physical therapist. The project will answer if a 3 month physical therapy intervention using MET causes changes in pain level, function and activity level for patients with knee osteoarthritis. In addition, it will investigate whether a single global endurance workout for 30 minutes will have an effect on pain level for these patients
- Conditions
- Osteoarthritis, Knee
- Being tested
- Medical Exercise Therapy
- Keywords
- Exercise Therapy, Musculoskeletal Pain, Knee osteoarthritis, Physical Therapy Modalities
- Medical subject headings
- Osteoarthritis, Knee, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Exercise TherapyBehavioural
physiotherapy intervention with Medical exercise therapy (MET) during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Medical Exercise Therapy | Experimental | Medical Exercise Therapy (MET) developed by Oddvar Holten Receives: Behavioral: Medical Exercise Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
visual analog scale
Measured: 6 months
Activity level
Accelerometer
Measured: 6 months
Function
30 second chair stand test
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 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 Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Håvard Østerås, phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905747
- Sponsor's protocol ID
- 2016/872
- Status last verified
- Mar 2019
- First submitted
- 14 Sep 2016
- Last updated
- 11 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Osteras H, Paulsberg F. The Effect of Medical Exercise Therapy on Pressure Sensitivity in Patients with Knee Osteoarthritis: A Cohort Pilot Study. Pain Ther. 2019 Jun;8(1):79-87. doi: 10.1007/s40122-019-0121-5. Epub 2019 Mar 30.
PubMed 30929225
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02905747
- Acronym / sponsor ID
- 2016/872
- Conditions
- Osteoarthritis, Knee
- Keywords
- Exercise Therapy, Musculoskeletal Pain, Knee osteoarthritis, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 19 Sep 2016 (estimated)
- 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.
The aim of the project is to investigate effects of medical exercise therapy (MET) on patients with knee osteoarthritis. MET is a common physical therapy intervention, and the project aim to strengthen the evidence of this intervention. An experimental cohort design is chosen, and 20 participants will be followed for 6 months. Assessments will be clinical tests, questionnaires and accelerometer measurements before, during, and after a 3 month period of exercise (3 days per week) with a physical therapist. The project will answer if a 3 month physical therapy intervention using MET causes changes in pain level, function and activity level for patients with knee osteoarthritis. In addition, it will investigate whether a single global endurance workout for 30 minutes will have an effect on pain level for these patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medical Exercise Therapy | Experimental | Behavioral: Medical Exercise TherapyMedical Exercise Therapy (MET) developed by Oddvar Holten |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- x-ray verified knee osteoarthritis (Kellegren \& Lawrence grade I-III)
- Loss of function and withstanding pain >3 months
Key exclusion criteria (6 listed)
- physical therapy treatment during the last 3 months
- knee injury
- inflammatory arthritis
- symptoms from the hip joints greater than the knee pain
- planned knee surgery the next 6 months
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 |
|---|---|---|
| Medical Exercise Therapyphysiotherapy intervention with Medical exercise therapy (MET) during 3 months | Behavioural | Medical Exercise Therapy |
Primary outcome
pain
Time frame: 6 months
visual analog scale
Activity level
Time frame: 6 months
Accelerometer
Function
Time frame: 6 months
30 second chair stand test
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 11 Mar 2019.
- Derived from this study: PubMed 30929225Osteras H, Paulsberg F. The Effect of Medical Exercise Therapy on Pressure Sensitivity in Patients with Knee Osteoarthritis: A Cohort Pilot Study. Pain Ther. 2019 Jun;8(1):79-87. doi: 10.1007/s40122-019-0121-5. Epub 2019 Mar 30.
- Individual participant dataSharing planned: Undecided
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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.
Håvard Østerås, phd principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Exercise Therapy in people with Osteoarthritis, Knee, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 6 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 11 Mar 2019. 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 Norway. 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?
pain (time frame: 6 months). The study lists 3 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 NCT02905747, 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 11 Mar 2019.