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Cartilage Adaptation and Response to Interleukins and Exercise (CARTILEX)

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise.
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteo Arthritis Knee focused on measuring exercise, cytokines, collagen

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Institute of Sports Medicine Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise group

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cytokine and enzymes concentration in synovial fluid
By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in synovial fluid will be measured.
Cytokine and enzymes concentration in blood
By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in the blood will be measured.
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.
Strength
By calculating the total volume of weight lifted (kg) the strength will be measured.
Body mass index (BMI)
BMI measured as the total body weight divided by the height squared (kg/m^2)
Age
The age measured in years

Full Information

First Posted
January 19, 2018
Last Updated
September 24, 2019
Sponsor
Bispebjerg Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03410745
Brief Title
Cartilage Adaptation and Response to Interleukins and Exercise
Acronym
CARTILEX
Official Title
The Effect of Exercise on the Collagen Synthesis and Cytokine Response in Human Cartilage Tissue With Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
September 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
exercise, cytokines, collagen

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise.
Intervention Description
Moderate to heavy intensity resistance exercise consisting of leg press.
Primary Outcome Measure Information:
Title
Collagen synthesis in articular cartilage
Description
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 Outcome Measure Information:
Title
Cytokine and enzymes concentration in synovial fluid
Description
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
Title
Cytokine and enzymes concentration in blood
Description
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
Title
Gene expression
Description
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
Title
Strength
Description
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
Title
Body mass index (BMI)
Description
BMI measured as the total body weight divided by the height squared (kg/m^2)
Time Frame
At the beginning of the study.
Title
Age
Description
The age measured in years
Time Frame
At the beginning of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam EM Jørgensen, MD
Organizational Affiliation
Institute of Sports Medicine, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Sports Medicine Copenhagen
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

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Cartilage Adaptation and Response to Interleukins and Exercise

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