COPDNCT07506317
Comparative Effects of Wim Hoff Method and Box Breathing Method in Mild COPD
A study testing Box Breathing and Wim Hoff Breathing Technique in people with COPD, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- COPD
- What is being tested?
- Box Breathing and Wim Hoff Breathing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Bahawal Victoria Hospital BVH Bahawalpur
Chak Eighty-seven -Twelve Left, Punjab Province, 63100
About this study
Official title: Comparative Effects of Wim Hoff Method and Box Breathing on Anxiety, Dyspnea and Peak Expiratory Flow Rate 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.
Read the detailed description
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.
- Conditions
- COPD
- Being tested
- Box Breathing, Wim Hoff Breathing Technique
- Keywords
- Breathing techniques, Wim Hoff, Box Breathing, comparison, COPD, Mild COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Box BreathingOther
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 TechniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Box Breathing | Experimental | Using Box Breathing as primary intervention in addition to baseline COPD therapy Receives: Other: Box Breathing |
| Wim Hoff breathing technique | Experimental | Using Wim Hoff breathing technique as primary intervention in addition to baseline COPD therapy Receives: Other: Wim Hoff Breathing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEFR
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.
Measured: 8 weeks
FEV1
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 .
Measured: 8 weeks
STAI for anxiety
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.
Measured: 8 weeks
Borg Dyspnea scale
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Jan 2025
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qurat ul Ain, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506317
- Sponsor's protocol ID
- REC/RCR & AHS/24/0378 Muntaha
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Wim Hoff Method and Box Breathing on Anxiety, Dyspnea and Peak Expiratory Flow Rate in Mild Copd
- ClinicalTrials.gov ID
- NCT07506317
- Acronym / sponsor ID
- REC/RCR & AHS/24/0378 Muntaha
- Conditions
- COPD
- Keywords
- Breathing techniques, Wim Hoff, Box Breathing, comparison, COPD, Mild COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Box Breathing | Experimental | Other: Box BreathingUsing Box Breathing as primary intervention in addition to baseline COPD therapy |
| Wim Hoff breathing technique | Experimental | Other: Wim Hoff Breathing TechniqueUsing Wim Hoff breathing technique as primary intervention in addition to baseline COPD therapy |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Box BreathingThe 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. | Other | Box Breathing |
| Wim Hoff Breathing TechniqueThe 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. | Other | Wim Hoff breathing technique |
Primary outcome
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.
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 .
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- The diagnosis and treatment of COPD and its comorbiditiesLink provided by the sponsor.
- COPD. Do the right thingLink provided by the sponsor.
- The impact of age on prevalence of anxiety, depression and stress in patients with chronic obstructive pulmonary disease.Link provided by the sponsor.
- How to use peak expiratory flow rate.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qurat ul Ain, MS principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Box Breathing and Wim Hoff Breathing Technique in people with COPD, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEFR (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.