ClinicalTrials.gg
CompletedNCT03410745CARTILEXUpdated Sep 25, 2019

Cartilage Adaptation and Response to Interleukins and Exercise

An interventional study of Exercise. in Osteo Arthritis Knee, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-09-25.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
40 Years to 90 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Motor Activity by Bispebjerg Hospital — 2 open to participants now, 3 under way, none of them phase 3. Motor Activity · Bispebjerg Hospital.

Enrollment
13th of 13
32 · median 152
Started
2018
the only one that year
No phase
11 of 16
2 open now
Registered
12th of 16
by date

Among the 16 studies in Motor Activity by Bispebjerg Hospital, this one is the 13th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2018, is one of 11 with no phase, and was the 12th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

2 of the 16 studies in Motor Activity by Bispebjerg Hospital are open now, in 3 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 40 Years to 90 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies in Motor Activity by Bispebjerg Hospital, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Osteo Arthritis Knee

Browse trials for

Keywords

  • exercise
  • cytokines
  • collagen
04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary osteoarthritis of the knee scheduled for knee replacement surgery
  • Must be able to perform physical exercise
  • Age 40-90 years old
  • 18.5-40 kg/m\^2
  • None smoker for the last 6 weeks

Exclusion criteria

Exclusion Criteria:

  • Regular intake of:
  • non anti-inflammatory drugs (NSAID)
  • corticoid-steroids
  • disease modifying anti-rheumatic drugs (DMARD)
  • cytostatic incl. chemotherapy
  • immune suppressive medicine
  • 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Exercise group

    Behavioral: Exercise.

  • No intervention
    Control group

Interventions

  • BehavioralExercise.

    Moderate to heavy intensity resistance exercise consisting of leg press.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: End of study at 4 weeks

Secondary outcomes

  1. Cytokine and enzymes concentration in synovial fluid

    By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in synovial fluid will be measured.

    Time frame: End of study at 4 weeks

  2. Cytokine and enzymes concentration in blood

    By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in the blood will be measured.

    Time frame: At the beginning and at the end of the study at 4 weeks

  3. 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.

    Time frame: End of study at 4 weeks

  4. Strength

    By calculating the total volume of weight lifted (kg) the strength will be measured.

    Time frame: At the beginning and at the end of the study at 4 weeks

  5. Body mass index (BMI)

    BMI measured as the total body weight divided by the height squared (kg/m\^2)

    Time frame: At the beginning of the study.

  6. Age

    The age measured in years

    Time frame: At the beginning of the study.

07

Study locations

1 site
  • Institute of Sports Medicine Copenhagen
    Copenhagen, 2400, Denmark
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Sep 2019, 18 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 18 months is close to that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2018
First posted
Jan 25, 2018
StartActual
Feb 21, 2018
Primary completionActual
Sep 10, 2019
CompletionActual
Sep 10, 2019
Last update
Sep 25, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03410745
Responsible party
Adam El Mongy Jørgensen, MD (Principal Investigator, Medical Doctor, Bispebjerg Hospital) — Principal investigator
First posted
Jan 25, 2018
Start date
Feb 21, 2018
Primary completion
Sep 10, 2019
Completion
Sep 10, 2019
Last update
Sep 25, 2019

Study contacts

Adam EM Jørgensen, MD
principal investigator · Institute of Sports Medicine, Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion