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临床试验/NCT07506317
NCT07506317已完成不适用

Comparative Effects of Wim Hoff Method and Box Breathing on Anxiety, Dyspnea and Peak Expiratory Flow Rate in Mild Copd

Riphah International University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
PEFR

研究概览

简要总结

The goal of this clinical trial is to support the role of effective, non-pharmacological interventions in the management of the symptoms of mild Chronic Obstructive Pulmonary Disease (COPD) or the anxiety, dyspnea, and peak expiratory flow rate decline. The main questions it aims to answer are

  • There are no significant effects of wim hoff breathing and box breathing technique on dyspnea, anxiety, and PEFR in mild COPD patients.
  • There are significant effects of wim hoff breathing and box breathing technique on dyspnea, anxiety, and PEFR in mild COPD patients.

There 2 study groups, group A received box breathing technique and Group B of mild COPD patients received wim hoff breathing technique.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) is a progressive respiratory condition that causes airflow limitation, leading to symptoms such as dyspnea, chronic cough, and anxiety. COPD significantly affects patients' quality of life, with anxiety and breathlessness often exacerbating the disease's impact. Traditional treatments primarily focus on medication, but non-pharmacological interventions like controlled breathing techniques have gained attention for their potential benefits in symptom management.

The objective is to determine the effects of the Wim Hof Method and Box Breathing on anxiety, dyspnea, and pulmonary function (PEFR and FEV1) in patients with mild COPD, assessing which method offers greater benefits in managing these symptoms. It is a randomized clinical trial was conducted with 60 participants diagnosed with mild COPD. Participants were assigned to either the Wim Hof Method group or the Box Breathing group by simple randomization technique of computer-generated random number table. Over 8 weeks, both groups practiced their respective breathing techniques, and assessments of anxiety (State-Trait Anxiety Inventory), dyspnea (Borg Dyspnea Scale), and pulmonary function (PEFR and FEV1) were performed pre- and post-treatment. Statistical analysis included Mann-Whitney U tests and Wilcoxon signed-rank tests.

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
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients
  • Age 35 and 50 years
  • Patients diagnosed with mild COPD with and FEV1 80%-85% of predicted.
  • Participants should have physical and cognitive ability to perform and understand exercises.
  • Participants who quit smoking over 6 months

排除标准

  • History of other respiratory conditions (asthma, interstitial lung disease, cystic fibrosis) excluded.
  • Patients of cardiovascular conditions were not included.
  • Neurological or psychiatric and cognitive disorders excluded.
  • Recent history of COPD hospitalization.
  • Participants formally engage in pulmonary rehabilitation programs in last 6 months.

结局指标

主要结局

PEFR

时间窗: 8 weeks

Peak Forced Expiratory Rate (PFER) is a vital measure in pulmonary health, assessing the maximum speed of exhalation to gauge lung function, particularly in asthma and COPD patients. It is measured in liters per minute using a peak flow meter, providing instant feedback on airway health. Patients monitor PFER to track airway constriction, adjusting medication as needed. The zone system include Green Zone (80-100%) indicates stable control, Yellow Zone,(50-79%) signals caution, Red Zone (below 50%) requires urgent attention.

FEV1

时间窗: 8 weeks

Forced Expiratory Volume in 1 Second (FEV1) measures the air exhaled in one second after a deep breath, serving as a critical indicator of lung function and a key diagnostic tool for obstructive lung diseases like asthma and COPD. Measured via spirometry, FEV1 is compared to predicted values and paired with Forced Vital Capacity (FVC) to calculate the FEV1/FVC ratio, differentiating obstructive from restrictive diseases. In COPD classification, FEV1 aids in determining severity: Mild (≥80% of predicted), Moderate (50-79%), Severe (30-49%), and Very Severe (\<30%). Tracking FEV1 over time helps clinicians assess progression, adjust treatments, and manage respiratory health effectively .

STAI for anxiety

时间窗: 8 weeks

The State-Trait Anxiety Inventory (STAI) is a psychological tool that assesses anxiety through two scales: State Anxiety (temporary anxiety linked to specific situations) and Trait Anxiety (a general, long-term tendency toward anxiety). With 40 self-report items, it measures how individuals feel at the moment (state) and their baseline anxiety levels over time (trait). Used widely in clinical and research settings, the STAI helps in diagnosing anxiety, tracking treatment progress, and providing insights into situational versus personality-based anxiety. Its dual approach enables a deeper understanding of anxiety, supporting personalized interventions and research into anxiety patterns across populations.

Borg Dyspnea scale

时间窗: 8 weeks

The Borg Dyspnea Scale is a subjective tool for rating breathlessness, commonly used in assessing respiratory conditions like COPD, asthma, and heart failure. It ranges from 0 (no breathlessness) to 10 (maximum breathlessness), with descriptive terms for each level to help individuals rate their symptoms accurately. Widely applied in clinical, exercise, and rehabilitation settings, the scale enables healthcare providers to gauge a patient's perceived breathlessness, adjust treatment, and monitor symptom changes over time.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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