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临床试验/NCT05426993
NCT05426993已完成不适用

Investigation of the Effects of Metabolic Syndrome on the Results of Complex Decongestive Physiotherapy in Lymphedema Patients

Gulhane School of Medicine1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Limb volume

研究概览

简要总结

As a result of our research, investigators could not find any study investigating the effectiveness of complex decongestive physiotherapy (KBF) in lymphedema patients with metabolic syndrome. Therefore, our aim is to compare the effectiveness of KBF in patients with and without metabolic syndrome.

详细描述

This study was planned to investigate the effects of metabolic syndrome seen in patients with lymphedema on the results of complex decongestive physiotherapy. Lymphedema is a chronic disease characterized by the accumulation of protein-rich fluid in the interstitial space. Among all the treatment approaches known in the field, Complex Decongestive Physiotherapy (CDT) is accepted as the gold standard in the treatment of lymphedema. CDT is a treatment approach consisting of manual lymph drainage, skin care, compression bandage and exercises. In clinical studies conducted to date, the effectiveness of CDFT in the treatment of lower and upper extremity lymphedema has been clearly demonstrated.

Metabolic syndrome is a medical term that describes the combination of various cardiovascular risk factors such as insulin resistance, impaired glucose tolerance or diabetes mellitus, obesity, abdominal fat accumulation, dyslipidemia, hypertension, and coronary artery disease. Obesity, the cardinal component of the metabolic syndrome, is a well-known risk factor for lymphedema, and increased body mass index (BMI) is associated with the frequency and severity of lymphedema. Obesity often accompanies lymphedema due to the effect of lymphedema and the characteristics of patients with lymphedema.

Our aim in this study, which was planned in the light of these data, is to examine whether the presence of metabolic syndrome in patients with lymphedema changes the effectiveness of CDT.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Those between the ages of 18-65,
  • To be diagnosed with lymphedema in the lower or upper extremities
  • Volunteering to participate in the study
  • Getting >24 points from the Standardized Mini mental test

排除标准

  • Having a score of <24 on the Standardized Mini Mental Test
  • Finding any problem preventing communication

结局指标

主要结局

Limb volume

时间窗: 15.09.2022

Edema evaluation will be made for the lower extremity from the lateral malleolus to the groin at 4 cm intervals. For the upper extremity, it will be made from the styloid process of the ulna to the axilla at intervals of 4 cm. The extremity volume will be determined from the values obtained with the help of the Frustrum formula.

次要结局

  • Life quality(15.12.2022)

研究者

发起方
Gulhane School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Ertuğrul Yaşa

Assocc. Prof.

Gulhane School of Medicine

研究点 (1)

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