NCT03410745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

February 21, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

1.6 years

First QC Date

January 19, 2018

Last Update Submit

September 24, 2019

Conditions

Osteo Arthritis Knee

Keywords

exercisecytokinescollagen

Outcome Measures

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.

    End of study at 4 weeks

Secondary Outcomes (6)

  • Cytokine and enzymes concentration in synovial fluid

    End of study at 4 weeks

  • Cytokine and enzymes concentration in blood

    At the beginning and at the end of the study at 4 weeks

  • Gene expression

    End of study at 4 weeks

  • Strength

    At the beginning and at the end of the study at 4 weeks

  • Body mass index (BMI)

    At the beginning of the study.

  • +1 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL
Behavioral: Exercise.

Control group

NO INTERVENTION

Interventions

Exercise.BEHAVIORAL

Moderate to heavy intensity resistance exercise consisting of leg press.

Exercise group

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Sports Medicine Copenhagen

Copenhagen, 2400, Denmark

Location

Related Publications (1)

  • Jorgensen AEM, Schjerling P, DellaValle B, Rungby J, Kjaer M. Acute loading has minor influence on human articular cartilage gene expression and glycosaminoglycan composition in late-stage knee osteoarthritis: a randomised controlled trial. Osteoarthritis Cartilage. 2023 Jul;31(7):884-893. doi: 10.1016/j.joca.2023.01.317. Epub 2023 Jan 30.

    PMID: 36720425DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Adam EM Jørgensen, MD

    Institute of Sports Medicine, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Doctor

Study Record Dates

First Submitted

January 19, 2018

First Posted

January 25, 2018

Study Start

February 21, 2018

Primary Completion

September 10, 2019

Study Completion

September 10, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

DK(1)