Cartilage Adaptation and Response to Interleukins and Exercise

Osteo Arthritis Knee Clinical Trial

— CARTILEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410745
• Other study ID #: BBH-139
• Status: Completed
• Phase: N/A
• Start date: February 21, 2018
• Est. completion date: September 10, 2019

Study information

• Verified date: September 2019
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 10, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Exercise.
Moderate to heavy intensity resistance exercise consisting of leg press.

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	End of study at 4 weeks
Secondary	Cytokine and enzymes concentration in synovial fluid	By using Enzyme-Linked Immunosorbent Assay (ELISA) the concentration of cytokines in synovial fluid will be measured.	End of study at 4 weeks
Secondary	Cytokine and enzymes concentration in blood	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
Secondary	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.	End of study at 4 weeks
Secondary	Strength	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
Secondary	Body mass index (BMI)	BMI measured as the total body weight divided by the height squared (kg/m^2)	At the beginning of the study.
Secondary	Age	The age measured in years	At the beginning of the study.