Osteo Arthritis KneeCARTILEXNCT03410745
Cartilage Adaptation and Response to Interleukins and Exercise
A study testing Exercise. in people with Osteo Arthritis Knee, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
This study will examine the effect of exercise on the turnover of collagen in articular cartilage and the content of cytokines in the synovial fluid from human adults with osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Exercise.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Feb 2018to 10 Sep 2019
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the knee scheduled for knee replacement surgery
- Must be able to perform physical exercise
- Age 40-90 years old
- BMI 18.5-40 kg/m^2
- None smoker for the last 6 weeks
Who cannot join
- Regular intake of:
- non steroid anti-inflammatory drugs (NSAID)
- corticoid-steroids
- disease modifying anti-rheumatic drugs (DMARD)
- cytostatic incl. chemotherapy
- immune suppressive medicine
Show all 11Show fewer
- Inflammatory diseases or cancer
- Recent trauma to the knee (< 3 months)
- Previous knee surgery
- Regular strenuous exercise ( > 1 pr. month)
- Previous exposure to tracers (e.g. from another study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise on the Collagen Synthesis and Cytokine Response in Human Cartilage Tissue With Osteoarthritis
This study will examine the effect of exercise on the turnover of collagen in articular cartilage and the content of cytokines in the synovial fluid from human adults with osteoarthritis.
Read the detailed description
By using stabile isotope labelling, this study will track the formation and destination of newly formed cartilage collagen in adult humans scheduled for knee replacement surgery due to osteoarthritis. The collagen formation as well as the effect on the cytokine content of the synovial fluid will be examined both at rest and in response to 4 weeks of exercise/training. Overall the project aims to improve the basic understanding of cartilage development and function in relation to osteoarthritis prevention.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Exercise.
- Keywords
- exercise, cytokines, collagen
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise.Behavioural
Moderate to heavy intensity resistance exercise consisting of leg press.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Behavioral: Exercise. |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collagen synthesis in articular cartilage
By using incorporation of stabile isotope tracers measured by gas chromatography, the concentration of newly formed collagen will be measured.
Measured: End of study at 4 weeks
Secondary outcomes (6)
Cytokine and enzymes concentration in synovial fluid
By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in synovial fluid will be measured.
Measured: End of study at 4 weeks
Cytokine and enzymes concentration in blood
By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in the blood will be measured.
Measured: At the beginning and at the end of the study at 4 weeks
Gene expression
By using real time reverse transcriptase polymerase chain reaction (RT-PCR) the concentration of messenger ribonucleic acid (mRNA) in cartilage tissue will be measured.
Measured: End of study at 4 weeks
Strength
By calculating the total volume of weight lifted (kg) the strength will be measured.
Measured: At the beginning and at the end of the study at 4 weeks
Body mass index (BMI)
BMI measured as the total body weight divided by the height squared (kg/m^2)
Measured: At the beginning of the study.
Age
The age measured in years
Measured: At the beginning of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start21 Feb 2018
- Primary completion10 Sep 2019
- Study completion10 Sep 2019
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 KneeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam El Mongy Jørgensen, MD, Bispebjerg Hospital
- Investigators
- Adam EM Jørgensen, MD, Principal investigator, Institute of Sports Medicine, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410745
- Sponsor's protocol ID
- BBH-139
- Acronym
- CARTILEX
- Status last verified
- Sep 2019
- First submitted
- 19 Jan 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jorgensen AEM, Schjerling P, DellaValle B, Rungby J, Kjaer M. Acute loading has minor influence on human articular cartilage gene expression and glycosaminoglycan composition in late-stage knee osteoarthritis: a randomised controlled trial. Osteoarthritis Cartilage. 2023 Jul;31(7):884-893. doi: 10.1016/j.joca.2023.01.317. Epub 2023 Jan 30.
PubMed 36720425
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on the Collagen Synthesis and Cytokine Response in Human Cartilage Tissue With Osteoarthritis
- ClinicalTrials.gov ID
- NCT03410745
- Acronym / sponsor ID
- CARTILEX / BBH-139
- Conditions
- Osteo Arthritis Knee
- Keywords
- exercise, cytokines, collagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 25 Jan 2018 (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 will examine the effect of exercise on the turnover of collagen in articular cartilage and the content of cytokines in the synovial fluid from human adults with osteoarthritis.
Detailed description
By using stabile isotope labelling, this study will track the formation and destination of newly formed cartilage collagen in adult humans scheduled for knee replacement surgery due to osteoarthritis. The collagen formation as well as the effect on the cytokine content of the synovial fluid will be examined both at rest and in response to 4 weeks of exercise/training. Overall the project aims to improve the basic understanding of cartilage development and function in relation to osteoarthritis prevention.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise. |
| Control group | No intervention | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary osteoarthritis of the knee scheduled for knee replacement surgery
- Must be able to perform physical exercise
- Age 40-90 years old
- BMI 18.5-40 kg/m^2
- None smoker for the last 6 weeks
Key exclusion criteria (11 listed)
- Regular intake of:
- non steroid anti-inflammatory drugs (NSAID)
- corticoid-steroids
- disease modifying anti-rheumatic drugs (DMARD)
- cytostatic incl. chemotherapy
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 |
|---|---|---|
| Exercise.Moderate to heavy intensity resistance exercise consisting of leg press. | Behavioural | Exercise group |
Primary outcome
Collagen synthesis in articular cartilage
Time frame: End of study at 4 weeks
By using incorporation of stabile isotope tracers measured by gas chromatography, the concentration of newly formed collagen will be measured.
6 secondary outcomes
Cytokine and enzymes concentration in synovial fluid
Time frame: End of study at 4 weeks
Cytokine and enzymes concentration in blood
Time frame: At the beginning and at the end of the study at 4 weeks
Gene expression
Time frame: End of study at 4 weeks
Strength
Time frame: At the beginning and at the end of the study at 4 weeks
Body mass index (BMI)
Time frame: At the beginning of the study.
Age
Time frame: At the beginning of the study.
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 25 Sep 2019.
- Derived from this study: PubMed 36720425Jorgensen AEM, Schjerling P, DellaValle B, Rungby J, Kjaer M. Acute loading has minor influence on human articular cartilage gene expression and glycosaminoglycan composition in late-stage knee osteoarthritis: a randomised controlled trial. Osteoarthritis Cartilage. 2023 Jul;31(7):884-893. doi: 10.1016/j.joca.2023.01.317. Epub 2023 Jan 30.
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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.
Adam EM Jørgensen, MD principal investigator
Institute of Sports Medicine, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise. in people with Osteo Arthritis Knee, run by Bispebjerg 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 5 inclusion and 11 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 25 Sep 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 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?
Collagen synthesis in articular cartilage (time frame: End of study at 4 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 NCT03410745, 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 25 Sep 2019.