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NCT Number: NCT07506317

Comparative Effects of Wim Hoff Method and Box Breathing Method in Mild COPD

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bahawal Victoria Hospital BVH Bahawalpur

Chak Four Hundred Fifty-four, Punjab Province, 63100, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Box Breathing

Other

The protocol for box breathing, which is a powerful technique for stress management and relaxation, guided patients through a structured breathing exercise.

The box breathing exercise consisted of the following steps:

  • Inhaled Deeply: Patients breathed in slowly through their nose, counting to 4, allowing their lungs to fill fully and gradually.
  • Held the Breath: They held their breath for a count of 4, maintaining a sense of calm as they allowed the air to settle.
  • Exhaled Slowly: They released the breath through their mouth over a count of 4, focusing on the slow, controlled release of air.
  • Paused Again: After exhaling, they held the breath out for a final count of 4, embracing the brief stillness before the next cycle.

Wim Hoff Breathing Technique

Other

The Wim Hof Breathing Technique was introduced as a powerful method to improve physical and mental resilience, boost energy, and enhance control over the nervous and immune systems.

The protocol for the Wim Hof Breathing Technique included the following steps:

Preparation:

Participants began by sitting or lying down in a comfortable position in a safe, quiet environment where they could practice without disturbances.

Step 1: 30-40 Deep, Rhythmic Breaths Step 2: Hold Your Breath (Retention Phase) Step 3: Recovery Breath Step 4: Repeat the Cycle

Duration of Practice:

Each full session of the Wim Hof Breathing Technique, including all breathing cycles, took around 15-20 minutes. These treatment sessions continued for 8 weeks.

Primary outcomes

  1. PEFR

    Time frame: 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.

  2. FEV1

    Time frame: 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 .

  3. STAI for anxiety

    Time frame: 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.

  4. Borg Dyspnea scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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