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临床试验/NCT07455968
NCT07455968进行中(未招募)不适用

Effects of Free Diving Breathing Training on Symptoms in Patients With Allergic Rhinitis

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8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
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Rhinitis symptom scores

研究概览

简要总结

The purpose of this study was to investigate the effects of diver-style breathing training on symptoms, pulmonary function, and respiratory muscle, in patients with allergic rhinitis.

详细描述

This study aims to investigate the effects of diver-style breathing training in patients with allergic rhinitis. A total of 30 patients aged 18-35 years were recruited from students and staff of Chulalongkorn University, as well as patients attending the Chulalongkorn University Health Service Center and King Chulalongkorn Memorial Hospital. Participants were randomly assigned into two groups: an experimental group (n = 15) that received diver-style breathing training and a control group (n = 15) that continued their usual daily activities without any exercise intervention.

The independent variable was diver-style breathing training. The dependent variables included rhinitis symptom outcomes (symptom scores, Peak Nasal Inspiratory Flow, nasal blood flow, and Fractional Exhaled Nitric Oxide), pulmonary function parameters (FVC, FEV1, FEV1/FVC, FEF25-75%, MVV, and breath-holding time), and respiratory muscle strength (MIP and MEP).

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with persistent allergic rhinitis (allergen of any type), both male and female, presenting with nasal congestion, sneezing, nasal itching, and rhinorrhea occurring more than 4 days per week, with an average symptom score greater than
  • Eligibility was determined using the Rhinitis Symptoms Score (0, 1, 2, and ≥3 scale) assessed over the previous week and on the day of testing. Participants must not have any complications such as sinusitis, Eustachian tube dysfunction, or asthma.
  • No history of other respiratory diseases, including bronchitis, pertussis, pneumonia, pneumonitis, pulmonary aspergilloma, tuberculosis, asthma, lung cancer, emphysema, or other related conditions.
  • No regular exercise training exceeding 20 minutes per session, 3 days per week or more, during the 6 months prior to participation.
  • No regular consumption of vitamin supplements or herbal products at least 3 days per week during the 6 months prior to participation.
  • Ability to discontinue the following medications before and during the study period: Antihistamines for at least 3 days, Oral steroids and nasal steroids for at least 2 weeks, Leukotriene receptor antagonists for at least 1 week
  • Participants were permitted to use decongestants (pseudoephedrine) if necessary. All participants were advised to consult their primary physician before discontinuing any medication and to ensure that their physical condition was appropriate for participation in the breathing training program.
  • Willingness to participate voluntarily and provide written informed consent.

排除标准

  • Inability to continue participation due to unforeseen circumstances, such as injury or illness.
  • Absence from more than 8 training sessions out of a total of 40 sessions.
  • Withdrawal of consent or unwillingness to continue participation.
  • Inability to discontinue medications according to the specified criteria.
  • Exacerbation of allergic rhinitis symptoms that prevents continued participation, such as persistent rhinorrhea or severe nasal congestion causing difficulty breathing.

研究组 & 干预措施

Free diving breathing training

Experimental

干预措施: Free diving breathing training (Other)

Control group (Normal daily life)

No Intervention

结局指标

主要结局

Rhinitis symptom scores

时间窗: Change from Baseline Rhinitis symptom scores at 8 weeks.

Nasal symptoms were assessed using Total Nasal Symptom Score (TNSS) questionnaire. The subjects were asked to score symptoms of persistent allergic rhinitis before and after yoga training protocol. The total nasal symptom scores were computed as the sum of four individual nasal symptom scores; nasal congestion, itching, sneezing, and rhinorrhea. The scores ranged from 0 to 3 scale (0=none, 1=mild, 2=moderate, 3= severe)

Peak nasal inspiratory flow; PNIF

时间窗: Change from Baseline respiratory muscle strength at 8 weeks.

Participants were instructed to inhale through the device as quickly and forcefully as possible using a Peak Nasal Inspiratory Flow (PNIF) meter.

Nasal blood flow

时间窗: Change from Baseline Rhinitis symptom scores at 8 weeks.

Laser Doppler flowmetry (DRT4, Moor Instruments, UK) was used to measure the NBF. Before the test, each subject rested for 1 hour in a separate room. During the test, the participants were instructed to breathe normally and not to speak, cough, or move. A lateral endoscopic probe with a flexible 1.34-mm-diameter flexible nylon sheath was placed on the front of the nose.

Fractional Exhaled Nitric Oxide Testing; FeNO

时间窗: Change from Baseline Rhinitis symptom scores at 8 weeks.

FeNO Monitor (BedFont, UK) was used to measure the FeNO. The participants inhaled deeply for 2 to 3 seconds before exhaling slowly, which normally took 10 seconds.

次要结局

  • Forced Vital Capacity; FVC(Change from Baseline respiratory muscle strength at 8 weeks.)
  • Forced Expiratory Volume in one second; FEV1(Change from Baseline respiratory muscle strength at 8 weeks.)
  • Forced Expiratory Flow at 25-75% of FVC; FEF25 - 75 %(Change from Baseline respiratory muscle strength at 8 weeks.)
  • Maximum Voluntary Ventilation; MVV(Change from Baseline respiratory muscle strength at 8 weeks.)
  • Breath Holding Time Test(Change from Baseline respiratory muscle strength at 8 weeks.)
  • Maximal Inspiratory Pressure; MIP(Change from Baseline respiratory muscle strength at 8 weeks.)
  • Maximal expiratory pressure; MEP(Change from Baseline respiratory muscle strength at 8 weeks.)

研究者

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

Wannaporn Tongtako, Ph.D.

Principal investigator

Chulalongkorn University

研究点 (1)

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