NCT07506317

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 16, 2026

Last Update Submit

March 27, 2026

Conditions

Keywords

Breathing techniquesWim HoffBox BreathingcomparisonCOPDMild COPD

Outcome Measures

Primary Outcomes (4)

  • 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.

    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 .

    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.

    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.

    8 weeks

Study Arms (2)

Box Breathing

EXPERIMENTAL

Using Box Breathing as primary intervention in addition to baseline COPD therapy

Other: Box Breathing

Wim Hoff breathing technique

EXPERIMENTAL

Using Wim Hoff breathing technique as primary intervention in addition to baseline COPD therapy

Other: Wim Hoff Breathing Technique

Interventions

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.

Box Breathing

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.

Wim Hoff breathing technique

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahawal Victoria Hospital BVH Bahawalpur

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

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Qurat ul Ain, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

April 1, 2026

Study Start

January 1, 2025

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations