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Completed

NCT Number: NCT03410745

Cartilage Adaptation and Response to Interleukins and Exercise

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.

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Key information

Conditions

Osteo Arthritis Knee Behavior Motor Activity

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Sports Medicine Copenhagen

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise.

Behavioral

Moderate to heavy intensity resistance exercise consisting of leg press.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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)

  6. Age

    Time frame: At the beginning of the study.

    The age measured in years

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

The Effect of Exercise on the Collagen Synthesis and Cytokine Response in Human Cartilage Tissue With Osteoarthritis

Acronym: CARTILEX

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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