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临床试验/NCT05993650
NCT05993650已完成不适用

Inspiratory Muscle Training in Individuals With Chronic Venous Disease : A Randomized Controlled Study

Izmir Democracy University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年7月20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
2
主要终点
Maximal inspiratory pressure (MIP)

研究概览

简要总结

There is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.

详细描述

Chronic venous insufficiency (CVI) is defined as a very common condition that affects the venous system in the lower extremities, including various pathologies and subjective symptoms such as pain, cramps, restlessness in the legs, edema, itching and skin changes. CVI is a disease that develops due to venous hypertension in the lower extremities, resulting in impaired turbulent flow fields, venous distention, free radical formation and inflammation. In addition to being a cosmetic problem, symptoms such as pain, itching, burning, tingling, night cramps, edema, skin changes and venous ulcers in chronic cases can be seen. It is seen between 5-30% in the adult population. CVI affects 40% of the general population. Because of its high prevalence, chronic venous diseases are a common condition that causes major socioeconomic impacts. According to the studies; it has been observed that 32% of women and 40% of men have varicose veins, and any type of venous disease affects 40-50% of men and 50-55% of.

The main clinical features of CVI are dilated veins, edema, leg pain, muscle cramps, and cutaneous changes in the leg. Edema begins in the perimalleolar region and ascendes up the leg. Leg restlessness is often described as heaviness or pain after prolonged standing and is relieved by leg elevation. This discomfort is caused by increased intracompartmental and subcutaneous volume and pressure. Venous valves and venous pump are the two major determinants of venous flow. Venous valves play a role in directing the flow from the superficial system to the deep system and in its progression from the proximal veins to the distal veins.

Venous function is reflected in venous return, venous resistance, and its effects on cardiac output. Venous filling time is a parameter of venous function and is shortened as a result of valve insufficiency, vessel wall enlargement and inability of muscle pumps to work actively. The calf muscles compress the deep intramuscular veins, diverting blood flow from the veins to the heart. This mechanism depends on talocrural mobility and the force of contraction of the calf muscles. However, muscle pump dysfunction is not limited to the calf, but also includes inspiratory muscle dysfunction, such as when the diaphragm allows greater blood flow to the heart from the lower extremities, creating a suction effect on the inferior vena cava during inspiration and expiration. It has been shown that the respiratory cycle affects the increase of deep inspiration and the flow rate of the femoral vein and venous return in healthy individuals. When inspiratory muscle strength is insufficient, blood flow in the leg veins will decrease, increasing vascular resistance and thus systemic refill can be reduced. Increasing the muscle strength of inspiration with inspiratory muscle training is considered to increase venous return and improve symptoms of CVI, including pain and edema. However, there is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Single-blind study; the patients will not be informed about training group or control group and they will be evaluated and trained at different places and times.

入排标准

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

入选标准

  • Being diagnosed with CVI
  • Being between C1-C5 according to the 'Clinical, Etiologic, Anatomic, Pathophysiologic' (CEAP) scale,
  • To accept to participate in the study,

排除标准

  • Arterial diseases,
  • Presence of advanced cardiorespiratory diseases,
  • Having orthopedic and neurological disorders that may affect walking,
  • Presence of acute ulcer (< 3 months) and diabetic ulcers,
  • Being pregnant.
  • Having a history of deep vein thrombosis,
  • Having undergone venous system surgery

结局指标

主要结局

Maximal inspiratory pressure (MIP)

时间窗: After 6-week training

The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.

次要结局

  • FEV1 / FVC(After 6-week training.)
  • Peak flow rate (PEF)(After 6-week training.)
  • Aerobic capacity assessment(After 6-week training.)
  • Forced vital capacity (FVC)(After 6-week training.)
  • Maximal expiratory pressure (MEP)(After 6-week training)
  • Forced expiratory volume in the first second (FEV1)(After 6-week training.)
  • Flow rate 25-75% of forced expiratory volume (FEF 25-75%)(After 6-week training.)
  • Lower extremity strength(After 6-week training.)
  • Edema assessment(After 6-week training.)
  • Quality of life assessment(After 6-week training.)

研究者

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

Özlem Çınar Özdemir

Assoc. prof

Izmir Democracy University

研究点 (2)

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