Cigarette SmokingNCT06032793
Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness Among Healthy Smokers
A study testing Breathing exercises in people with Cigarette Smoking, run by Riphah International University at 1 site in Pakistan.
Trial summary
Effects of deep breathing exercise on pulmonary function, perceived stress and physical fitness among healthy smokers. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 1 Dec 2023
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Only Male Healthy Smoker.
- Age: 20 - 30 years.
- Participants had a minimum smoking history of 5 years.
- Subject without any chronic pulmonary complication.
Who cannot join
- Smokers with any pulmonary disease, acute infections, other systemic disease.
- Chest deformity or any disability.
- History of any surgery.
- Not willing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness Among Healthy Smokers.
Effects of deep breathing exercise on pulmonary function, perceived stress and physical fitness among healthy smokers.
Read the detailed description
Smoking is injurious to health as cigarette contains harmful substances that cause different life threatening diseases, like bronchitis, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular diseases etc. During normal breathing, oxygen is supplied to the body through blood circulation. But, in smokers, carbon monoxide (CO) is supplied to body instead of oxygen, resulting in respiratory issues, like breathlessness and coughing, in acute stages . Smoking decreases lung capacity, as it contains acidic substances which start damaging the lining of the bronchi and bronchioles due to which they become inflamed and infected, resulting into coughing, shortness of breath and chest pain that leads towards chronic bronchitis. This study will contribute our young smokers as they are adherent to smoking and its difficult for them to quit smoking. as their physical activity is limited, individuals under stress condition and with pulmonary complications so impact of this research is that along with helping smokers to quit smoking also applying alternative strategies to minimize complication and improve quality of life. and these alternative strategies include such activities that performed easily at home and do not require much effort or no need to go to gym or any other place to perform these exercises.
- Conditions
- Cigarette Smoking
- Being tested
- Breathing exercises
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercisesOther
Pursed lip breathing, Diaphragmatic breathing and powered breathing
| Study group | Role | What they receive |
|---|---|---|
| Deep breathing exercise | Experimental | This group will perform following exercises:
Pursed lip breathing, Diaphragmatic breathing and powered breathing for 3-4 times a day for 6 weeks. Receives: Other: Breathing exercises |
| No Intervention | No intervention | This group will not perform any exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity
The volume of air which can be forcefully expelled from the lungs after taking a deep breath is known as forced vital capacity (FVC). The normal range of FVC for an adult lies between 3.0 and 5.0 L (29). The participant will be asked to seal their lips tightly over the mouthpiece and inhale as deeply as possible. Then they will exhale as forcefully as they can.
Measured: baseline, on 2nd ,4th and 6th week
Forced Expiratory Volume
FEV1 assesses how much air an individual can forcefully exhale. The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. The forced expiratory volume (FEV) can be calculated for the first, second, and/or third seconds of the forced breath. With reference to GOLD range of COPD, the normal value for FEV is \<80. An FEV1 of less than 1 L indicates significant lung disease. For correct measures, the procedure will be repeated 3 times, and then the best value will be taken. The FEV1 is the measurement of dynamic volume most often used in conjunction with the FVC in analysis of spirometry.
Measured: baseline, on 2nd ,4th and 6th week
PERCEIVED STRESS
A more precise measure of personal stress can be determined by using a variety of instruments that have been designed to help measure individual stress levels. The first of these is called the Perceived Stress Scale. The Perceived Stress Scale (PSS) is a classic stress assessment instrument. It was originally developed in 1983.
Measured: baseline, on 2nd ,4th and 6th week
Physical Fitness
The six minute walking test (6MWT) will be used to determine the physical fitness. Each patient will be administered a 6-minute walk test. Two cones will be placed 100 feet apart in a hallway. Patients will instructed to walk as many laps around the cones as possible. A calibrated electronic pedometer (Omron Health Care Corporation, Vernon Hills, IL) will be worn on the hip of each patient to obtain the total number of steps taken during the test. Researcher will stand at the center of the 100-foot course and will encourage the patient after every 2 minutes. The researcher will record the time and distance to onset of exhaustion as well as the total distance walked and the total number of steps taken during the test. The walking distances will be subsequently converted from feet to meters.
Measured: baseline, 2nd, 4th and on 6th week
Secondary outcomes (1)
Sleep quality
To determine the sleep quality, Pittsburgh Sleep Quality Index (PSQI) will be used. It was designed to evaluate overall sleep quality in the populations with an internal reliability of a = .83, a test-retest reliability of .85 for the global scale, a sensitivity of 89.6%, and a specificity of 86.5%. Each of the questionnaire's 19 self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
Measured: baseline, 2nd, 4th and on 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malik Muhammad Ali Awan, MSPT, Principal investigator, Riphah International University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032793
- Sponsor's protocol ID
- REC/MS-PT/01656 Talliya Naz
- Status last verified
- Jan 2025
- First submitted
- 5 Sep 2023
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness Among Healthy Smokers.
- ClinicalTrials.gov ID
- NCT06032793
- Acronym / sponsor ID
- REC/MS-PT/01656 Talliya Naz
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 13 Sep 2023 (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.
Effects of deep breathing exercise on pulmonary function, perceived stress and physical fitness among healthy smokers.
Detailed description
Smoking is injurious to health as cigarette contains harmful substances that cause different life threatening diseases, like bronchitis, asthma, chronic obstructive pulmonary disease (COPD), cardiovascular diseases etc. During normal breathing, oxygen is supplied to the body through blood circulation. But, in smokers, carbon monoxide (CO) is supplied to body instead of oxygen, resulting in respiratory issues, like breathlessness and coughing, in acute stages . Smoking decreases lung capacity, as it contains acidic substances which start damaging the lining of the bronchi and bronchioles due to which they become inflamed and infected, resulting into coughing, shortness of breath and chest pain that leads towards chronic bronchitis. This study will contribute our young smokers as they are adherent to smoking and its difficult for them to quit smoking. as their physical activity is limited, individuals under stress condition and with pulmonary complications so impact of this research is that along with helping smokers to quit smoking also applying alternative strategies to minimize complication and improve quality of life. and these alternative strategies include such activities that performed easily at home and do not require much effort or no need to go to gym or any other place to perform these exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep breathing exercise | Experimental | Other: Breathing exercisesThis group will perform following exercises: Pursed lip breathing, Diaphragmatic breathing and powered breathing for 3-4 times a day for 6 weeks. |
| No Intervention | No intervention | –This group will not perform any exercise. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Only Male Healthy Smoker.
- Age: 20 - 30 years.
- Participants had a minimum smoking history of 5 years.
- Subject without any chronic pulmonary complication.
Key exclusion criteria (4 listed)
- Smokers with any pulmonary disease, acute infections, other systemic disease.
- Chest deformity or any disability.
- History of any surgery.
- Not willing to participate.
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 |
|---|---|---|
| Breathing exercisesPursed lip breathing, Diaphragmatic breathing and powered breathing | Other | Deep breathing exercise |
Primary outcome
Forced Vital Capacity
Time frame: baseline, on 2nd ,4th and 6th week
The volume of air which can be forcefully expelled from the lungs after taking a deep breath is known as forced vital capacity (FVC). The normal range of FVC for an adult lies between 3.0 and 5.0 L (29). The participant will be asked to seal their lips tightly over the mouthpiece and inhale as deeply as possible. Then they will exhale as forcefully as they can.
Forced Expiratory Volume
Time frame: baseline, on 2nd ,4th and 6th week
FEV1 assesses how much air an individual can forcefully exhale. The forced expiratory volume in 1 second (FEV1) is the volume of air (in liters) exhaled in the first second during forced exhalation after maximal inspiration. The forced expiratory volume (FEV) can be calculated for the first, second, and/or third seconds of the forced breath. With reference to GOLD range of COPD, the normal value for FEV is \<80. An FEV1 of less than 1 L indicates significant lung disease. For correct measures, the procedure will be repeated 3 times, and then the best value will be taken. The FEV1 is the measurement of dynamic volume most often used in conjunction with the FVC in analysis of spirometry.
PERCEIVED STRESS
Time frame: baseline, on 2nd ,4th and 6th week
A more precise measure of personal stress can be determined by using a variety of instruments that have been designed to help measure individual stress levels. The first of these is called the Perceived Stress Scale. The Perceived Stress Scale (PSS) is a classic stress assessment instrument. It was originally developed in 1983.
Physical Fitness
Time frame: baseline, 2nd, 4th and on 6th week
The six minute walking test (6MWT) will be used to determine the physical fitness. Each patient will be administered a 6-minute walk test. Two cones will be placed 100 feet apart in a hallway. Patients will instructed to walk as many laps around the cones as possible. A calibrated electronic pedometer (Omron Health Care Corporation, Vernon Hills, IL) will be worn on the hip of each patient to obtain the total number of steps taken during the test. Researcher will stand at the center of the 100-foot course and will encourage the patient after every 2 minutes. The researcher will record the time and distance to onset of exhaustion as well as the total distance walked and the total number of steps taken during the test. The walking distances will be subsequently converted from feet to meters.
1 secondary outcome
Sleep quality
Time frame: baseline, 2nd, 4th and on 6th week
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 13 Jan 2025.
- 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.
Malik Muhammad Ali Awan, MSPT principal investigator
Riphah International University, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercises in people with Cigarette Smoking, 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 4 inclusion and 4 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 13 Jan 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 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?
Forced Vital Capacity (time frame: baseline, on 2nd ,4th and 6th week). 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 13 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.