跳至主要内容
临床试验/NCT04402255
NCT04402255已完成不适用

The Effect of Pilates Based Exercise Practice on Physical and Psychological Parameters in Patients With Behçet and Familial Mediterranean Fever.

Istanbul University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Berg Balance Scale (BBS) Web sonuçları International Physical Activity Questionnaire - Short Form

研究概览

简要总结

Behcet's disease (BD) is a chronic systemic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. Musculoskeletal involvement such as arthritis, arthralgia, enthesitis and sacroiliitis can be seen in the course of BD. Familial Mediterranean fever (FMF) is the most frequent autoinflammatory disease (AID) and characterized by selflimited episodes of fever and polyserositis. It is the most common monogenic periodic fever syndrome that affects mainly the people of Mediterranean descent. Regular physical activity involving aerobic and strengthening programs in inflammatory rheumatic diseases has a long-term anti-inflammatory effect. Eccentric exercises cause an acute increase in TNF alpha level and should be avoided especially at the beginning. It has been stated that patients should be encouraged about aerobic exercise programs where the intensity is gradually increased, starting with low intensity. Pilates method is the mind and body centering technique developed by Joseph Hubertus Pilates, based on providing lumbopelvic stability. FMF and BH have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. When we look at the literature, there is no study on the effectiveness of exercise applications in FMF and Behçet patients. The purpose of our study; It is the comparison of the effectiveness of physical activity in patients diagnosed with Behçet and FMF and healthy individuals. In this context, with the short form of the International Physical Activity Evaluation Questionnaire, Behçet's patients whose physical activity level is inactive will be Group 1, FMF patients Group 2 and healthy controls with similar demographic characteristics will be Group 3. Pilates based exercise program will be applied to all 3 groups for 8 weeks, 2 times a week.

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
None

入排标准

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

入选标准

  • Being inactive or minimally active according to the International Physical Activity Survey
  • Being between the ages of 18-65
  • Being diagnosed with FMF at least 1 year ago according to diagnostic criteria
  • A diagnosis of BH at least 1 year ago according to the International Behçet Working Group
  • Having a cooperative level that can adapt to the evaluation and exercise program

排除标准

  • Those with any central nervous system involvement that may interfere with exercise
  • Those who do not want to participate in the study
  • Pregnant women
  • Having other chronic diseases
  • Psychiatric disorders and treated
  • Those with cognitive impairment

结局指标

主要结局

Berg Balance Scale (BBS) Web sonuçları International Physical Activity Questionnaire - Short Form

时间窗: change from baseline to 8 weeks, follow up at two months

The BBS is a 14- item balance test recognized as the gold standard tool for assessing balance (higher scores indicate better balance)

six minute walk test

时间窗: change from baseline to 8 weeks, follow up at two months

It is a simple test that measures the distance an individual can walk at a fast pace on a flat, hard floor in 6 minutes.

Biodex balance system (BBS)

时间窗: change from baseline to 8 weeks, follow up at two months

The BBS has a round foot platform that moves in all planes. It grants 20 degrees of foot platform motion in different directions. The platform has foot angles and heel coordinates for proper foot placement before starting the balance test trial. The foot angles range from 0° to 45° and heel coordinates are expressed as the intersection of letters from A to P and numbers from 1 to 21. The participants were asked to centralize their body while they placed their feet in the most comfortable position and their feet 10 cm apart with eyes open. They were asked to hold the rails in case they felt unbalanced. The machine measured the magnitude of their postural sways: higher scores for postural sway indicate impaired balance, and a lower score indicate excellent balance

次要结局

  • international physical activity questionnaire- short form(change from baseline to 8 weeks, follow up at two months)
  • Hamilton Depression Scale(change from baseline to 8 weeks, follow up at two months)
  • Nottingham Health Profile Questionnaire (NHP)(change from baseline to 8 weeks, follow up at two months)

研究者

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

Nejla Uzun

MSc, Pt

Istanbul University

研究点 (2)

Loading locations...

相似试验

Pilates Based Exercises in Patients With Behçet and... | 临床试验