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临床试验/NCT01576159
NCT01576159已完成早期 1 期

The Effect of Mechanical Loading During Sports Exercises on Degradation of Human Articular Cartilage

Middle East Technical University2 个研究点 分布在 2 个国家目标入组 48 人开始时间: 2008年1月最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
已完成
入组人数
48
试验地点
2
主要终点
Changes in Serum COMP Accumulation, Triggered by Acute Exercise, After 12 Weeks of Different Regular Exercises

研究概览

简要总结

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)

详细描述

Design

A prospective, parallel-group randomized control trial was designed. Mustafa Kemal University (MKU) Ethical Board approved the study (B.30.2.MKU.0.01.01.00/255). The exact nature of the study was explained to participants and they were asked to sign a written consent. The tests were carried out at Middle East Technical University Medical Center, Ankara, Turkey between January and June 2008. The independent variables were groups (n=4) and time (n=2). The dependent variable was serum cartilage oligomeric matrix protein (COMP) levels measured at three phases of exercise: before (Recovery), immediately after (Fatigue), and 30-min after the exercise (Regeneration). Participants were subjected to the following tests prior to and at the end of the intervention period: body mass index (BMI), isokinetic leg muscle strength, maximum oxygen consumption (VO2max) and serum COMP levels.

Participants

115 applicants volunteered to take part in this study. Eligibility screening was performed according to inclusion criteria. From 104 eligible applicants, 48 healthy, sedentary male university students aged between 18 to 25 years old (Mage = 21.8±1.9) were selected by a simple drawing. However, study completed with 44 participants, because of 4 dropouts. Participants were randomly assigned in 1:1:1:1 ratio to parallel groups, three exercise groups (swimming, cycling and running) and one control. In order to have a random allocation, each participant received a number unknown to researchers which was written on a piece of paper and then drawn from a box that allowed to assign individuals to the control and exercise groups. Baseline blood samples were stored in -80°C and they were not analyzed during participants' allocation. Exclusion criteria, surveyed by a questionnaire, were: osteoarthritis, rheumatoid arthritis or other inflammatory joint disease, intra-articular steroid injection, mal-alignment of the knees (varus/valgus) larger than 15°, and recent (within six months) fracture of lower extremity. Active athletes and volunteers with previous sports background were not included. During the intervention period, one participant was excluded from the study because of sudden kidney disease and another one decided to withdraw from further participation. In addition, two participants were excluded from the study before biochemical analyses since one subject from running group didn't meet minimum requirement of 75% of exercise session attendance, and one subject from control group didn't complete the posttests. Descriptive data of participants are presented in.

Interventions

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Control Group

No Intervention

Didn't participate any organized physical exercises

High-Impact Loading

Experimental

Performed high-impact running exercise during intervention period.

干预措施: Running exercise (Other)

Moderate-Impact Loading

Experimental

Performed moderate-impact cycling exercise during intervention period.

干预措施: Cycling exercise (Other)

Non-Impact Loading

Experimental

Performed low-impact swimming exercise during intervention period.

干预措施: Swimming Exercise (Other)

结局指标

主要结局

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

时间窗: Baseline and 12 weeks

次要结局

  • Physiological (Maximum Oxygen Consumption) Changes of Participants(Baseline and 12 weeks)
  • Physical (Body Mass Index) Changes of Participants(Baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feza Korkusuz

Prof. Dr.

Middle East Technical University

研究点 (2)

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