Smoking Electronic Cigarettes (Vaping), With Moderate and High Dependence for NicotineNCT07153640
EFFECT OF WIM HOF BREATHING EXERCISE ON VENTILATORY FUNCTIONS IN SMOKERS
A study testing 1 ) Wim Hof Breathing Exercise and 2) Aerobic exercises in people with Smoking Electronic Cigarettes (Vaping), With Moderate and High Dependence for Nicotine, run by October 6 University at 1 site in Egypt.
Trial summary
Cigarette smoking is the most common form of tobacco use worldwide, but other tobacco products, such as e-cigarettes, cigars, cigarillos, roll-your-own, pipes, and various smokeless tobacco products are also damaging. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking Electronic Cigarettes (Vaping), With Moderate and High Dependence for Nicotine
- What is being tested?
- 1 ) Wim Hof Breathing Exercise and 2) Aerobic exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • The age of the subjects ranged from 18-29 years old.
- The males are participated.
- Any subjects smoking electronic cigarettes (vaping).
- Subjects with body mass index between 18.5 - 29.9 Kg/m2.
- Penn State Electronic Cigarette Dependence Index (moderate and high dependent) (Appendix 1) (Maraqa et al., 2024).
Who cannot join
- • History of syncope (fainting).
- High blood pressure (>140/100 mm Hg) (Shandu et al., 2023a).
- Any type of heart disease.
- Seizures or Epilepsy.
- Recent surgery.
- Metabolic disorders.
- Subjects with body mass index more than 35 Kg/m2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Cigarette smoking is the most common form of tobacco use worldwide, but other tobacco products, such as e-cigarettes, cigars, cigarillos, roll-your-own, pipes, and various smokeless tobacco products are also damaging. Most harmful chemicals in cigarette smoke target metals or carbonyls generated by the thermal decomposition of carrier liquids such as propylene glycol, which is one of the main ingredients in the liquid used in electronic cigarettes, where it serves as both the carrier for nicotine and cannabinoids and the means of producing vapor which resemble smoke. This new tobacco product was made of milder sorts of tobacco, the smoke could be inhaled, and it was more damaging.
Read the detailed description
Smoking primarily causes diseases of the respiratory system, cancer, and the cardiovascular system. E-cigarettes are battery-powered devices that heat a liquid, usually containing nicotine and flavorings, to generate an aerosol for inhalation. In 2014, there were already more than 450 different e-cigarettes with now different generations and more than 8000 different liquids.
The increasing prevalence of smoking among college students presents a significant public health and educational problem, particularly in developing countries where smoking prevention measures are not Strictly enforced .
A healthy lifestyle can reduce the risk of disease. One of the unhealthy lifestyle patterns is consuming cigarettes. Smoking can also reduce the affinity of oxygen for hemoglobin so that it can affect oxygen saturation levels in the blood. Cigarette smoke that enters the body through the lungs contains carbon monoxide and nicotine enters the blood, and then flows throughout the body, and this has an impact on the muscles becoming deprived of oxygen intake, which causes muscle work to be hampered so that the work of the heart will also be hindered because of blockage of blood vessels. It makes the heart pump harder, decreasing the heart's work power.
Wim Hof breathing exercise is part of a structured regimen, called the Wim Hof Method (WHM), which consists of three pillars (breathing, cold exposure, and mindset training). The WHM breathing exercise consists of three or more rounds, each comprising three phases; Hyperventilation, Breath retention, and Recovery breath. The use of Wim Hof breathing method is one of the effective breathing techniques, that increase the level of oxygenation and Quality of Life.
- Being tested
- 1 ) Wim Hof Breathing Exercise, 2) Aerobic exercises
- Keywords
- WIM HOF BREATHING EXERCISE
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 ) Wim Hof Breathing ExerciseOther
- Subjects will be asked to breathe deeply for an average of 20-30 breaths then exhale, (deep rapid inhalations and relaxed expirations)
- Hold their breath in an unforced manner for one minute or longer until they feel the urge to breathe (retention phase). (For safety, they were instructed not to hold their breath longer than 3.5 min).
- Take deep inhalation breath and hold again for 15 seconds (recovery breath).
- This procedure was repeated a total of three times.
- After the last cycle, subjects were instructed to return to their natural rhythm of breathing and remain lying down without moving to relax for five minutes.
- Done every day in the morning or at least three hours postprandial for four weeks. (Marko et al., 2022)
2) Aerobic exercisesOther
Aerobic exercises were performed by walking on the treadmill for 30 minutes a day (5 days/week) and at least 150 minutes per week of moderate-intensity aerobic activity at 60-75% of the maximum heart rate (HR) for four weeks. Maximum heart rate is taken from 220 - to age. Both the warm-up and cool-down were performed for five minutes. Each session concluded with stretching the calf, hamstring, quadriceps, gluteus, back, neck, and shoulder muscles (Acar et al., 2024; Shandu et al., 2023a)
| Study group | Role | What they receive |
|---|---|---|
| Wim Hof Breathing Exercise group | Experimental | In the study group, subjects in this group will receive Wim Hof Breathing Exercise every day in the morning or at least three hours postprandial and aerobic exercise (5 days/week) for four weeks. Receives: Other: 1 ) Wim Hof Breathing Exercise; Other: 2) Aerobic exercises |
| control group | Active comparator | Subjects in the control group will receive only aerobic exercise (5 days/week) for four weeks. Receives: Other: 2) Aerobic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) Ventilatory Functions
for measuring FVC (forced vital capacity), FEV1(forced expiratory volume in first second), FEV1/FVC (forced expiratory volume in first second /forced vital capacity ratio) and PEF (peak expiratory flow).
Measured: four weeks
Secondary outcomes (5)
1) Functional Capacity
The 6-minute walk distance (6MWD) test for measuring functional capacity. Measured distance by meter.
Measured: four weeks
2) Oxygen saturation
Pulse oximetry provides a noninvasive approximation of the amount of oxygen in arterial blood.
Measured: four weeks
3) Hand grip strength
The gold standard for measuring grip strength is Hydraulic Hand Dynamometer.
Measured: four weeks
4) Smoking Craving
The 10-item Questionnaire on Smoking Urges (QSU-Brief) is a self-report measure designed to assess urges and cravings to smoke, with higher scores indicating stronger urges.
Measured: four weeks
5) Academic Performance
The Academic Performance Scale (APS) is a questionnaire designed to assess academic performance among students based on student self-reports.
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking Electronic Cigarettes (Vaping), With Moderate and High Dependence for NicotineStudies 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
- Model description
- A Randomized, Double-blind Controlled Clinical Trial (RCT) in which the selected subject will be divided randomly blinded into two groups (21 subjects for study group and 21 subjects for control group). In the study group, subjects in this group will receive Wim Hof Breathing Exercise every day in the morning or at least three hours postprandial and aerobic exercise (5 days/week) for four weeks. Subjects in the control group will receive only aerobic exercise (5 days/week) for four weeks. Both groups will be evaluated at baseline and after the end of the treatment program.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Kadry Abd Elghany Elnaqeeb, October 6 University
- Investigators
- EMAN KADRY ELNAQEEB, Master degree, Principal investigator, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153640
- Sponsor's protocol ID
- P.T.REC/012/005934
- Status last verified
- Apr 2025
- First submitted
- 16 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF WIM HOF BREATHING EXERCISE ON VENTILATORY FUNCTIONS IN SMOKERS
- ClinicalTrials.gov ID
- NCT07153640
- Acronym / sponsor ID
- P.T.REC/012/005934
- Keywords
- WIM HOF BREATHING EXERCISE
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 4 Sep 2025 (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.
Cigarette smoking is the most common form of tobacco use worldwide, but other tobacco products, such as e-cigarettes, cigars, cigarillos, roll-your-own, pipes, and various smokeless tobacco products are also damaging. Most harmful chemicals in cigarette smoke target metals or carbonyls generated by the thermal decomposition of carrier liquids such as propylene glycol, which is one of the main ingredients in the liquid used in electronic cigarettes, where it serves as both the carrier for nicotine and cannabinoids and the means of producing vapor which resemble smoke. This new tobacco product was made of milder sorts of tobacco, the smoke could be inhaled, and it was more damaging.
Detailed description
Smoking primarily causes diseases of the respiratory system, cancer, and the cardiovascular system. E-cigarettes are battery-powered devices that heat a liquid, usually containing nicotine and flavorings, to generate an aerosol for inhalation. In 2014, there were already more than 450 different e-cigarettes with now different generations and more than 8000 different liquids.
The increasing prevalence of smoking among college students presents a significant public health and educational problem, particularly in developing countries where smoking prevention measures are not Strictly enforced .
A healthy lifestyle can reduce the risk of disease. One of the unhealthy lifestyle patterns is consuming cigarettes. Smoking can also reduce the affinity of oxygen for hemoglobin so that it can affect oxygen saturation levels in the blood. Cigarette smoke that enters the body through the lungs contains carbon monoxide and nicotine enters the blood, and then flows throughout the body, and this has an impact on the muscles becoming deprived of oxygen intake, which causes muscle work to be hampered so that the work of the heart will also be hindered because of blockage of blood vessels. It makes the heart pump harder, decreasing the heart's work power.
Wim Hof breathing exercise is part of a structured regimen, called the Wim Hof Method (WHM), which consists of three pillars (breathing, cold exposure, and mindset training). The WHM breathing exercise consists of three or more rounds, each comprising three phases; Hyperventilation, Breath retention, and Recovery breath. The use of Wim Hof breathing method is one of the effective breathing techniques, that increase the level of oxygenation and Quality of Life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Double-blind Controlled Clinical Trial (RCT) in which the selected subject will be divided randomly blinded into two groups (21 subjects for study group and 21 subjects for control group). In the study group, subjects in this group will receive Wim Hof Breathing Exercise every day in the morning or at least three hours postprandial and aerobic exercise (5 days/week) for four weeks. Subjects in the control group will receive only aerobic exercise (5 days/week) for four weeks. Both groups will be evaluated at baseline and after the end of the treatment program.
| Arm | Type | Receives |
|---|---|---|
| Wim Hof Breathing Exercise group | Experimental | Other: 1 ) Wim Hof Breathing Exercise, Other: 2) Aerobic exercisesIn the study group, subjects in this group will receive Wim Hof Breathing Exercise every day in the morning or at least three hours postprandial and aerobic exercise (5 days/week) for four weeks. |
| control group | Active comparator | Other: 2) Aerobic exercisesSubjects in the control group will receive only aerobic exercise (5 days/week) for four weeks. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • The age of the subjects ranged from 18-29 years old.
Key exclusion criteria (7 listed)
- • History of syncope (fainting).
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 |
|---|---|---|
| 1 ) Wim Hof Breathing Exercise1. Subjects will be asked to breathe deeply for an average of 20-30 breaths then exhale, (deep rapid inhalations and relaxed expirations) 2. Hold their breath in an unforced manner for one minute or longer until they feel the urge to breathe (retention phase). (For safety, they were instructed not to hold their breath longer than 3.5 min). 3. Take deep inhalation breath and hold again for 15 seconds (recovery breath). 4. This procedure was repeated a total of three times. 5. After the last cycle, subjects were instructed to return to their natural rhythm of breathing and remain lying down without moving to relax for five minutes. 6. Done every day in the morning or at least three hours postprandial for four weeks. (Marko et al., 2022) | Other | Wim Hof Breathing Exercise group |
| 2) Aerobic exercisesAerobic exercises were performed by walking on the treadmill for 30 minutes a day (5 days/week) and at least 150 minutes per week of moderate-intensity aerobic activity at 60-75% of the maximum heart rate (HR) for four weeks. Maximum heart rate is taken from 220 - to age. Both the warm-up and cool-down were performed for five minutes. Each session concluded with stretching the calf, hamstring, quadriceps, gluteus, back, neck, and shoulder muscles (Acar et al., 2024; Shandu et al., 2023a) | Other | Wim Hof Breathing Exercise group, control group |
Primary outcome
1) Ventilatory Functions
Time frame: four weeks
for measuring FVC (forced vital capacity), FEV1(forced expiratory volume in first second), FEV1/FVC (forced expiratory volume in first second /forced vital capacity ratio) and PEF (peak expiratory flow).
5 secondary outcomes
1) Functional Capacity
Time frame: four weeks
2) Oxygen saturation
Time frame: four weeks
3) Hand grip strength
Time frame: four weeks
4) Smoking Craving
Time frame: four weeks
5) Academic Performance
Time frame: four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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.
EMAN KADRY ELNAQEEB, Master degree principal investigator
October 6 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 1 ) Wim Hof Breathing Exercise and 2) Aerobic exercises in people with Smoking Electronic Cigarettes (Vaping), With Moderate and High Dependence for Nicotine, run by October 6 University at 1 site in Egypt.
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 7 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: opening soon, as of the sponsor's last update on 4 Sep 2025. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMAN KADRY ELNAQEEB, Master degree (01289089380, Eman.Kadry.PT@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1) Ventilatory Functions (time frame: four weeks). 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 4 Sep 2025.