NCT01576159

Brief 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)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2008

Shorter than P25 for early_phase_1

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

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2012

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

June 10, 2015

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

5 months

First QC Date

April 9, 2012

Results QC Date

May 2, 2012

Last Update Submit

June 9, 2015

Conditions

Keywords

Biochemical MarkerFitness ExercisesImpactArticular Cartilage

Outcome Measures

Primary Outcomes (1)

  • Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises

    Baseline and 12 weeks

Secondary Outcomes (2)

  • Physical (Body Mass Index) Changes of Participants

    Baseline and 12 weeks

  • Physiological (Maximum Oxygen Consumption) Changes of Participants

    Baseline and 12 weeks

Study Arms (4)

High-Impact Loading

EXPERIMENTAL

Performed high-impact running exercise during intervention period.

Other: Running exercise

Moderate-Impact Loading

EXPERIMENTAL

Performed moderate-impact cycling exercise during intervention period.

Other: Cycling exercise

Non-Impact Loading

EXPERIMENTAL

Performed low-impact swimming exercise during intervention period.

Other: Swimming Exercise

Control Group

NO INTERVENTION

Didn't participate any organized physical exercises

Interventions

During this type of exercise intervention, subjects performed weight-bearing exercise. This group participated in sessions of 40-min per day, three days per week, for a period of 12 weeks

High-Impact Loading

During this type of exercise intervention, subjects performed a partial weight-bearing exercise. This group participated in sessions of 40-min per day, three days per week, for a period of 12 weeks

Moderate-Impact Loading

During this type of exercise intervention, subjects performed a non-weight bearing exercise. This group participated in sessions of 40-min per day, three days per week, for a period of 12 weeks

Non-Impact Loading

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Middle East Technical University, Medical Center and Physical Education and Sports Dep.

Ankara, Cankaya, 06531, Turkey (Türkiye)

Location

Related Publications (6)

  • Mundermann A, Dyrby CO, Andriacchi TP, King KB. Serum concentration of cartilage oligomeric matrix protein (COMP) is sensitive to physiological cyclic loading in healthy adults. Osteoarthritis Cartilage. 2005 Jan;13(1):34-8. doi: 10.1016/j.joca.2004.09.007.

    PMID: 15639635BACKGROUND
  • Andersson ML, Thorstensson CA, Roos EM, Petersson IF, Heinegard D, Saxne T. Serum levels of cartilage oligomeric matrix protein (COMP) increase temporarily after physical exercise in patients with knee osteoarthritis. BMC Musculoskelet Disord. 2006 Dec 7;7:98. doi: 10.1186/1471-2474-7-98.

    PMID: 17156423BACKGROUND
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND
  • Johnson EP. ACSM's Guidelines for Exercise Testing and Prescription. 6th ed. Baltimore: Lippincott, Williams and Wilkins, 2000.

    RESULT
  • Bompa TO. Periodization : theory and methodology ot training. Champaign, IL: Human Kinetics, 1999.

    RESULT
  • Field AP. Discovering Statistics Using SPSS for Windows: Advanced Techniques for Beginners. London: Sage Publications, Inc., 2000

    RESULT

MeSH Terms

Conditions

OsteoarthritisTooth, Impacted

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesTooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Ozgur Celik PhD.
Organization
Middle East Technical University

Study Officials

  • Ozgur Celik, PhD

    Middle East Technical University

    STUDY DIRECTOR
  • Feza Korkusuz, PhD

    Middle East Technical University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 9, 2012

First Posted

April 12, 2012

Study Start

January 1, 2008

Primary Completion

June 1, 2008

Study Completion

September 1, 2008

Last Updated

June 10, 2015

Results First Posted

June 10, 2015

Record last verified: 2015-06

Locations