- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06032793
Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness.
May 19, 2024 updated by: Riphah International University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Railway General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Only Male Healthy Smoker.
- Age: 20 - 30 years.
- Participants had a minimum smoking history of 5 years.
- Subject without any chronic pulmonary complication.
Exclusion Criteria:
- Smokers with any pulmonary disease, acute infections, other systemic disease.
- Chest deformity or any disability.
- History of any surgery.
- Not willing to participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deep breathing exercise
This group will perform following exercises: Pursed lip breathing, Diaphragmatic breathing and powered breathing for 3-4 times a day for 6 weeks. |
Pursed lip breathing, Diaphragmatic breathing and powered breathing
|
No Intervention: No Intervention
This group will not perform any exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline, on 2nd ,4th and 6th week
|
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.
|
baseline, on 2nd ,4th and 6th week
|
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.
|
baseline, on 2nd ,4th and 6th week
|
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.
|
baseline, 2nd, 4th and on 6th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sleep quality
Time Frame: baseline, 2nd, 4th and on 6th week
|
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.
|
baseline, 2nd, 4th and on 6th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Malik Muhammad Ali Awan, MSPT, Riphah International University, Islamabad
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
December 1, 2023
Study Completion (Actual)
December 1, 2023
Study Registration Dates
First Submitted
September 5, 2023
First Submitted That Met QC Criteria
September 5, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
May 21, 2024
Last Update Submitted That Met QC Criteria
May 19, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- REC/MS-PT/01656 Talliya Naz
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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