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临床试验/NCT07153640
NCT07153640尚未招募不适用

EFFECT OF WIM HOF BREATHING EXERCISE ON VENTILATORY FUNCTIONS IN SMOKERS

October 6 University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
42
试验地点
1
主要终点
1) Ventilatory Functions

研究概览

简要总结

Cigarette smoking is the most common form of tobacco use worldwide, but other tobacco products, such as e-cigarettes, cigars, cigarillos, roll-your-own, pipes, and various smokeless tobacco products are also damaging. Most harmful chemicals in cigarette smoke target metals or carbonyls generated by the thermal decomposition of carrier liquids such as propylene glycol, which is one of the main ingredients in the liquid used in electronic cigarettes, where it serves as both the carrier for nicotine and cannabinoids and the means of producing vapor which resemble smoke. This new tobacco product was made of milder sorts of tobacco, the smoke could be inhaled, and it was more damaging.

详细描述

Smoking primarily causes diseases of the respiratory system, cancer, and the cardiovascular system. E-cigarettes are battery-powered devices that heat a liquid, usually containing nicotine and flavorings, to generate an aerosol for inhalation. In 2014, there were already more than 450 different e-cigarettes with now different generations and more than 8000 different liquids.

The increasing prevalence of smoking among college students presents a significant public health and educational problem, particularly in developing countries where smoking prevention measures are not Strictly enforced .

A healthy lifestyle can reduce the risk of disease. One of the unhealthy lifestyle patterns is consuming cigarettes. Smoking can also reduce the affinity of oxygen for hemoglobin so that it can affect oxygen saturation levels in the blood. Cigarette smoke that enters the body through the lungs contains carbon monoxide and nicotine enters the blood, and then flows throughout the body, and this has an impact on the muscles becoming deprived of oxygen intake, which causes muscle work to be hampered so that the work of the heart will also be hindered because of blockage of blood vessels. It makes the heart pump harder, decreasing the heart's work power.

Wim Hof breathing exercise is part of a structured regimen, called the Wim Hof Method (WHM), which consists of three pillars (breathing, cold exposure, and mindset training). The WHM breathing exercise consists of three or more rounds, each comprising three phases; Hyperventilation, Breath retention, and Recovery breath. The use of Wim Hof breathing method is one of the effective breathing techniques, that increase the level of oxygenation and Quality of Life.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

A Randomized, Double-blind Controlled Clinical Trial (RCT) in which the selected subject will be divided randomly blinded into two groups (21 subjects for study group and 21 subjects for control group). In the study group, subjects in this group will receive Wim Hof Breathing Exercise every day in the morning or at least three hours postprandial and aerobic exercise (5 days/week) for four weeks. Subjects in the control group will receive only aerobic exercise (5 days/week) for four weeks.

Both groups will be evaluated at baseline and after the end of the treatment program.

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • • The age of the subjects ranged from 18-29 years old.
  • The males are participated.
  • Any subjects smoking electronic cigarettes (vaping).
  • Subjects with body mass index between 18.5 - 29.9 Kg/m
  • Penn State Electronic Cigarette Dependence Index (moderate and high dependent) (Appendix 1) (Maraqa et al., 2024).

排除标准

  • • History of syncope (fainting).
  • High blood pressure (>140/100 mm Hg) (Shandu et al., 2023a).
  • Any type of heart disease.
  • Seizures or Epilepsy.
  • Recent surgery.
  • Metabolic disorders.
  • Subjects with body mass index more than 35 Kg/m2.

结局指标

主要结局

1) Ventilatory Functions

时间窗: four weeks

for measuring FVC (forced vital capacity), FEV1(forced expiratory volume in first second), FEV1/FVC (forced expiratory volume in first second /forced vital capacity ratio) and PEF (peak expiratory flow).

次要结局

  • 2) Oxygen saturation(four weeks)
  • 1) Functional Capacity(four weeks)
  • 4) Smoking Craving(four weeks)
  • 3) Hand grip strength(four weeks)
  • 5) Academic Performance(four weeks)

研究者

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

Eman Kadry Abd Elghany Elnaqeeb

Assistant lectuer

October 6 University

研究点 (1)

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