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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Feza Korkusuz, Middle East Technical University
ClinicalTrials.gov Identifier:
NCT01576159
First received: April 9, 2012
Last updated: June 9, 2015
Last verified: June 2015
Results First Received: May 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Screening
Conditions: Osteoarthritis
Articular Cartilage Disorder of Knee
Degenerative Lesion of Articular Cartilage of Knee
Interventions: Other: Running exercise
Other: Cycling exercise
Other: Swimming Exercise

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
High-Impact Loading Performed high-impact running exercise during intervention period.
Moderate-Impact Loading Performed moderate-impact cycling exercise during intervention period.
Non-Impact Loading Performed low-impact swimming exercise during intervention period.
Control Group Didn't participate any organized physical exercises

Participant Flow:   Overall Study
    High-Impact Loading     Moderate-Impact Loading     Non-Impact Loading     Control Group  
STARTED     12     12     12     12  
COMPLETED     11     11     11     11  
NOT COMPLETED     1     1     1     1  
Withdrawal by Subject                 0                 1                 0                 0  
Physician Decision                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 0                 1  
Protocol Violation                 1                 0                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
High-Impact Loading Performed high-impact running exercise during intervention period.
Moderate-Impact Loading Performed moderate-impact cycling exercise during intervention period.
Non-Impact Loading Performed low-impact swimming exercise during intervention period.
Control Group Didn't participate any organized physical exercises
Total Total of all reporting groups

Baseline Measures
    High-Impact Loading     Moderate-Impact Loading     Non-Impact Loading     Control Group     Total  
Number of Participants  
[units: participants]
  11     11     11     11     44  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     11     11     11     11     44  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  20.7  (1.3)     21.1  (1.5)     22.8  (1.9)     22.6  (2.1)     21.8  (1.9)  
Gender  
[units: participants]
         
Female     0     0     0     0     0  
Male     11     11     11     11     44  
Region of Enrollment  
[units: participants]
         
Turkey     11     11     11     11     44  



  Outcome Measures
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1.  Primary:   Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Physical (Body Mass Index) Changes of Participants   [ Time Frame: Baseline and 12 weeks ]

3.  Secondary:   Physiological (Maximum Oxygen Consumption) Changes of Participants   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ozgur Celik PhD.
Organization: Middle East Technical University
phone: +903122104016 ext 3663
e-mail: ozgur@udel.edu


Publications of Results:
Johnson EP. ACSM's Guidelines for Exercise Testing and Prescription. 6th ed. Baltimore: Lippincott, Williams and Wilkins, 2000.
Bompa TO. Periodization : theory and methodology ot training. Champaign, IL: Human Kinetics, 1999.
Field AP. Discovering Statistics Using SPSS for Windows: Advanced Techniques for Beginners. London: Sage Publications, Inc., 2000

Other Publications:

Responsible Party: Feza Korkusuz, Middle East Technical University
ClinicalTrials.gov Identifier: NCT01576159     History of Changes
Other Study ID Numbers: BAPK06K07K03K00K17, 107S112
Study First Received: April 9, 2012
Results First Received: May 2, 2012
Last Updated: June 9, 2015
Health Authority: Turkey: Ethics Committee