跳至主要内容
临床试验/NCT02761590
NCT02761590Unknown不适用

Influence of a Circuit Trining Protocol on Intermuscular Adipose Tissue of Knee Osteoarthritis Patients: a Randomized Controlled Trial

Universidade Federal de Sao Carlos2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Change from baseline Intermuscular adipose tissue (IMAT) at 14 weeks

研究概览

简要总结

Introduction: The increase in intermuscular adipose tissue (IMAT) can contribute to muscle weakness and consequently on progression of knee OA. The prescription of exercise protocols has been used as a treatment strategy to minimize some of the bouts. Circuit training (CT) involves the combination of strength training and aerobic in the same session and has shown benefits in body composition and physical function. But the literature is unclear with respect to the influences of CT in the concentration of IMAT in the population with knee OA. Objective: To investigate the influence of a 14-week CT protocol in body composition and thigh IMAT concentration as well as cartilage degradation indicators and systemic inflammation and its impact on quality of life in patients with knee OA.

详细描述

This study presents a randomized controlled trial design. They will be selected 40 participants diagnosed with knee OA grades II and III, aged 40 and 65 years and BMI <30 kg / m2 were randomly divided into two groups: participants underwent training (trained group - TG) and not subjected to training ( untrained group - NTG). The participants trained group will undergo a periodized CT protocol of 14 weeks load progression, 3 times a week, with sessions last 15 minutes in the first weeks and will arrive 35 minutes in final weeks, and added 10 minutes between heating and cooling down. All subjects will conduct pre and post CT variables: IMAT thigh (computed tomography); body composition (Dual-energy X-ray absorptiometry - DXA), inflammatory biomarker concentrations: IL-1β, IL-6, IL-10, TNF-α, leptin and adiponectin and joint degradation biomarkers (uCTX-II and sCOMP), performance tests functional (six-minute walk, 30 seconds chair stand test and stair climb test), muscle strength (maximum voluntary isometric contraction - MVIC), WOMAC and KOOS questionnaires, and catastrophizing pain scale. During the training protocol, uCTX-II variables, sCOMP and MVIC will also be evaluated. To compare the groups will be applied the unpaired t-test. When found significant main effects, the Bonferroni test will be used to identify the statistically significant differences. To compare the collections times (pre, during and post TC) for uCTX-II variables, sCOMP and MVIC will be held repeated measures ANOVA with post hoc Bonferroni, and the WOMAC variables, KOOS, DXA, IMAT, functional testing and inflammatory cytokines (pre and post CT) will be held the paired t test. A significance level of 5% (p ≤ 0.05) will be adopted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged between 40 and 65
  • sedentary
  • radiographically and clinically diagnosed with knee OA

排除标准

  • performed physical therapy or exercise protocol up to 6 months prior to the beginning of the evaluations of this study
  • previous knee surgeries
  • previous history of trauma to the lower limb
  • corticosteroid infiltration in knees in the 30 days prior to baseline
  • prosthesis (partial or total) hip or knee arthritis
  • use of chondroprotective
  • cognitive deficits that compromise the understanding of tests and exercises
  • body mass index (BMI) ≥30 kg / m²
  • heart disease uncontrolled
  • history of muscle injuries severe (above grade I)
  • motor deficits due to neuromuscular disease
  • cardiac pacemaker use
  • chronic diseases
  • impaired renal function, or any other medical condition that makes it impossible to participate in this study.

研究组 & 干预措施

Circuit training protocol

Experimental

The CT protocol will be held in three sessions per week for 14 weeks. The volume of work is defined by the training section of time and intensity of effort by the heart rate response to exercise.

The construction of own model of periodization to be used complies with the biological principle of interdependence volume vs. intensity, and duration of 14 weeks, proposing a week of recuperative exercises after two weeks of stress, gradually increasing the intensity with respective volume settings. This model is based on the concepts described by Turner et al. that concludes in favor of the organization of training adapted to the reality of the public to be trained.

干预措施: Circuit training protocol (Other)

Strength training protocol

Active Comparator

The strength training protocol was performed in three sessions per week for 14 weeks and divided into three levels.

The initial load set for each exercise was based on the one repetition maximum test (1 RM). Strengthening exercises were performed in two sets of 15 repetitions, using 25% 1RM for hip adductors and abductors, and 50% 1RM for the quadriceps and hamstrings, using ankle weights. Exercises for the trunk were performed in 3 10-second series, increasing the duration when participants were able.

干预措施: Circuit training protocol (Other)

Educational Protocol

No Intervention

In order to provide care, social interaction, and health education, an educational protocol was conducted. This protocol consisted in interactive presentations of 60 minutes, twice a month for 14 weeks, totaling 7 meetings. The topics addressed pathophysiology of osteoarthritis, and American College of Rheumatology (ACR) recommendations on nutrition, posture, and lifestyle.

结局指标

主要结局

Change from baseline Intermuscular adipose tissue (IMAT) at 14 weeks

时间窗: baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training

The concentration of intermuscular fat tissue will be measured by computed tomography. The images will be obtained through a CT scanner Multislice (Brilliance CT 16-slice, Phillips), located at the University Hospital of San Carlos. The examination will be conducted by experienced personnel under the supervision of a radiologist, developer of this study. The suggested protocol will provide an image related to the mid-thigh area of both legs. Quantification of intermuscular fat quadriceps muscle will be carried out by a slice thickness of 10 mm corresponding to half the distance between the greater trochanter and the intercondylar notch of the femur. The analyzes of the areas will be manually performed using the software OsiriX., And the area of interest selected by a scan, in accordance with the density of tissue decay rates for quantification of adipose tissue present in cm2.

次要结局

  • Muscle strength(baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training)
  • Inflammation and degradation of cartilage biomarkers(baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training)
  • Body composition(baseline and post intervention (week 14 - the analysis will be conducted on the first week immediately after the end of the training)

研究者

发起方
Universidade Federal de Sao Carlos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aline Castilho de Almeida

MSc

Universidade Federal de Sao Carlos

研究点 (2)

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