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临床试验/NCT05988294
NCT05988294招募中不适用

Pulmonary Function, Respiratory Muscle Strength and Functional Capacity Response to Pilates Exercises in Patients With Inhalation Injury After Thermal Burn.

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Forced vital capacity (FVC)

研究概览

简要总结

Inhalation injury is a composite of multiple insults including: supraglottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.

详细描述

Extra lung mucus secretions, injured mucosa, contaminants, and aspirated substances should be handled in their early stages. In the case of fibrinous material transudates, compromised mucociliary secretions and mucosal slough must be cleared. There are different methods to assist the clearance of secretions as bronchoscopy, ventilator, mucolytics, suction, and chest physiotherapy.

In Pilates method (PM), several muscles are activated, including the muscles involved in breathing, especially to improve the expiratory function, which remains contracted during the inspiratory and expiratory phase. Breathing control is fundamental during the execution of PM exercises, where the practitioner learns how to breathe properly as an essential part of each exercise through forceful exhaling followed by complete inhaling. Thus, adequate breathing aids in controlling movements, and therefore, the method can be regarded as an indirect strategy for respiratory muscle training. It is known that poor control of breathing can result in compensation and lung volumes and respiratory muscle performance, with several factors involved.

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
Single (Care Provider)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients in both sexes and their age will range from 20-50 years.
  • Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA).
  • Patients suffering from retained secretions which did not respond to medical treatment. (4) All patients should be clinically and medically stable.
  • (5) All patients should have the same medical treatment.

排除标准

  • Participants with a history of regular physical activity (regular exercise habit > 3 times/ week or >150 min/ week) in the last 6 months.
  • Participants with less than an 85% attendance rate at the sessions.
  • Participants with any dysfunction that limit physical activity such as neurological disorders, chronic obstructive pulmonary disease, uncontrolled hypertension, malignancy, cardiovascular diseases, deep vein thrombosis, rheumatoid arthritis, orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, or hearing impairments and contractures.
  • Pregnant females.
  • Obese participants (BMI > 30 kg/m2).
  • Participants use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.

结局指标

主要结局

Forced vital capacity (FVC)

时间窗: 12 weeks

Forced vital capacity (FVC) will be measured by using spirometer

forced expiratory volume in 1 second (FEV1)

时间窗: 12 weeks

forced expiratory volume in 1 second (FEV1) will be measured by using spirometer

peak expiratory flow (PEF)

时间窗: 12 weeks

peak expiratory flow (PEF) will be measured by using spirometer

次要结局

  • Respiratory muscle strength(12 weeks)
  • Functional capacity(12 weeks)

研究者

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

Nesma Morgan Allam

Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Cairo University

研究点 (2)

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