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临床试验/NCT06220903
NCT06220903已完成不适用

The Effect of Complex Decongestive Therapy on Fluid Excretion From The Body in Patients With Lymphedema

Medipol University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Liquid Intake-Urine Excretion Tracking

研究概览

简要总结

The aim of this study is to investigate objectively the effect of lymphatic fluid which is circulated with Complex Decongestive Therapy on fluid excretion from the body in patients with lymphedema.

详细描述

The lymphatic system is the accessory circulatory system that takes lymph fluid from the interstitial space and adds it to the blood circulation. It starts from the interstitial space. It consists of lymph vessels, lymph fluid and lymphatic organs. Lymph fluid passes through many lymph nodes during its transport and is filtered in these nodules. The lymphatic system takes lymphatic fluid from the tissues and brings it to the venous part of the circulatory system. The main task of the lymph system is to reabsorb substances that cannot be absorbed by the blood circulation system. Non-absorbable substances in the interstitial space are called lymphatic load. Lymphatic load; It consists of protein, water, fat and cells. The aim of lymphedema treatment is to remove the protein-rich fluid accumulated in the interstitial space into the venous system. There are many factors in the flow of lymph fluid into the veins. The most important of these is the high filtration pressure that occurs when fluid is filtered through blood capillaries. Lymph fluid flowing from the periphery to the center is generally affected by pressure changes and moves from where the pressure is high to where it is low. Contraction of the muscles adjacent to the lymph vessels, pulsation of the neighboring arteries, and the effect of the smooth muscles in the lymph vessel wall also cause pressure changes. Other factors include respiratory movements acting as a pump in the lymph flow, the actual pressure effect of abdominal pressure on the cisterna chyli, and negative intrathoracic pressure.

Complex Decongestive Physiotherapy is proven effective and considered the gold standard for the treatment of lymphedema. It increases the hydrostatic pressure that has decreased due to edema and helps the lymph fluid to re-enter the circulation.

Purpose of the study; To objectively investigate whether the lymph fluid added to the circulation through Complex Decongestive Physiotherapy in lymphedema patients has an effect on fluid excretion from the body.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Female cases
  • •Cases diagnosed with lower extremity unilateral/bilateral lymphedema
  • •Having received or not received radiotherapy and/or chemotherapy

排除标准

  • •Having received treatment for lymphedema in the last year
  • •Having metastatic disease
  • •Those diagnosed with severe heart failure and/or arrhythmia
  • •Arterial disorders
  • •Kidney diseases
  • •Infection in affected extremities
  • •Psychological disorders
  • •Nephrotic syndrome
  • •Diuretic use
  • •Patients using chemotherapy and drugs that have toxic effects on the kidneys
  • •Those with liver cirrhosis, liver disease
  • •Neurological diseases

研究组 & 干预措施

Treatment Group

Experimental

Complex DecongestivePhysiotherapy program was planned for the affected extremity of the cases. The treatment was performed 5 days a week, for 4 weeks, for a total of 20 sessions and each session was 60 minutes. The treatment included Manual Lymph Drainage, skin care, multi-layer bandaging, exercise and compression stockings.

干预措施: Complex Decongestive Therapy (Other)

结局指标

主要结局

Liquid Intake-Urine Excretion Tracking

时间窗: 4 weeks

The subjects were asked to fill out a 24-hour fluid intake-urine excretion chart to evaluate the difference between fluid intake and urine excretion.

MoistureMeterD Compact Device

时间窗: 4 weeks

Tissue dielectric constant technique provides information about the emergence of lymphedema in the early stages and the change in the amount of water under the skin. A high-frequency electromagnetic wave produced by the device is directed to the skin by contacting the probe with the skin. The effective measurement depth is 2.5 mm. The device evaluates the amount of water under the tissue thought to be the beginning of lymphedema.

次要结局

  • Body Mass Index(4 weeks)
  • Range of motion(4 weeks)
  • Evaluation of edema(4 weeks)
  • Lymphedema Quality of Life(4 weeks)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilanur Özkaraoğlu, PT, MSc

Assistant Professor

Medipol University

研究点 (1)

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