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Early Phase 1 N=48 Randomized Screening

Serum Cartilage Oligomeric Matrix Protein Levels After 12 Weeks of Different Exercises

Osteoarthritis · Articular Cartilage Disorder of Knee · Degenerative Lesion of Articular Cartilage of Knee

Enrolled (actual)
48
Serious AEs
Results posted
Jun 2015
Primary outcome: Primary: Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises — -1.60; -0.53; -0.19; -0.12 U/l

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
Running exercise (Other); Cycling exercise (Other); Swimming Exercise (Other)
Age
Adult · 18+ yrs
Sex
Male
Sponsor
Middle East Technical University
Primary completion
Jun 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises
-1.60; -0.53; -0.19; -0.12
SECONDARY
Physical (Body Mass Index) Changes of Participants
-0.73; -0.49; -0.72; -0.07
SECONDARY
Physiological (Maximum Oxygen Consumption) Changes of Participants
4.91; 2.93; 5.46; 1.11

Summary

Acute effects of physical exercise on the deformational behavior of articular cartilage and changes in cartilage oligomeric matrix protein (COMP) are definite. However, conclusive positive effects of fitness exercise on functional adaptation of articular cartilage have not been proved.Therefore, in this parallel-group randomized control trial, the investigators tested the hypothesis that adequate amount of physical exercise with enough impact would be able to stimulate the functional behavior of articular cartilage. The investigators evaluated 44 healthy males for their physical fitness levels and their blood samples were obtained before, immediately after and 0.5 h after a 30-min walking exercise. Thereafter, participants were assigned to the running, the cycling, the swimming and the control groups. At the end of 12-weeks of intervention, same measurement procedures were applied. Mixed repeated-measures ANOVA design was used for statistics. (Level of evidence: 2)

Eligibility Criteria

Inclusion Criteria

  • body mass index lower than 30
  • availability of participants for the tests and attendance to training sessions

Exclusion Criteria

  • osteoarthritis, rheumatoid arthritis or other inflammatory joint disease
  • intra-articular steroid injection
  • mal-alignment of the knees (varus/valgus) larger than 15°
  • recent (within six months) fracture of lower extremity.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01576159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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