Cartilage Adaptation and Response to Interleukins and Exercise (CARTILEX)

September 24, 2019 updated by: Adam El Mongy Jørgensen, MD, Bispebjerg Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Institute of Sports Medicine Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Regular intake of:
  • non steroid 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Exercise group
Behavioral: Exercise.
Moderate to heavy intensity resistance exercise consisting of leg press.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
End of study at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine and enzymes concentration in synovial fluid
Time Frame: End of study at 4 weeks
By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in synovial fluid will be measured.
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
By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in the blood will be measured.
At the beginning and at the end of the study at 4 weeks
Gene expression
Time Frame: End of study at 4 weeks
By using real time reverse transcriptase polymerase chain reaction (RT-PCR) the concentration of messenger ribonucleic acid (mRNA) in cartilage tissue will be measured.
End of study at 4 weeks
Strength
Time Frame: At the beginning and at the end of the study at 4 weeks
By calculating the total volume of weight lifted (kg) the strength will be measured.
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.
BMI measured as the total body weight divided by the height squared (kg/m^2)
At the beginning of the study.
Age
Time Frame: At the beginning of the study.
The age measured in years
At the beginning of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Adam EM Jørgensen, MD, Institute of Sports Medicine, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2018

Primary Completion (Actual)

September 10, 2019

Study Completion (Actual)

September 10, 2019

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH-139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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