xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032793</url>
    </required_header>
    <id_info>
      <org_study_id>REC/MS-PT/01656 Talliya Naz</org_study_id>
      <nct_id>NCT06032793</nct_id>
    </id_info>
    <brief_title>Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness.</brief_title>
    <official_title>Effects of Deep Breathing Exercise on Pulmonary Function, Perceived Stress and Physical Fitness Among Healthy Smokers.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Effects of deep breathing exercise on pulmonary function, perceived stress and physical&#xD;
        fitness among healthy smokers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Smoking is injurious to health as cigarette contains harmful substances that cause different&#xD;
        life threatening diseases, like bronchitis, asthma, chronic obstructive pulmonary disease&#xD;
        (COPD), cardiovascular diseases etc. During normal breathing, oxygen is supplied to the body&#xD;
        through blood circulation. But, in smokers, carbon monoxide (CO) is supplied to body instead&#xD;
        of oxygen, resulting in respiratory issues, like breathlessness and coughing, in acute stages&#xD;
        . Smoking decreases lung capacity, as it contains acidic substances which start damaging the&#xD;
        lining of the bronchi and bronchioles due to which they become inflamed and infected,&#xD;
        resulting into coughing, shortness of breath and chest pain that leads towards chronic&#xD;
        bronchitis. This study will contribute our young smokers as they are adherent to smoking and&#xD;
        its difficult for them to quit smoking. as their physical activity is limited, individuals&#xD;
        under stress condition and with pulmonary complications so impact of this research is that&#xD;
        along with helping smokers to quit smoking also applying alternative strategies to minimize&#xD;
        complication and improve quality of life. and these alternative strategies include such&#xD;
        activities that performed easily at home and do not require much effort or no need to go to&#xD;
        gym or any other place to perform these exercises.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Forced Vital Capacity</measure>
      <time_frame>baseline, on 2nd ,4th and 6th week</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Forced Expiratory Volume</measure>
      <time_frame>baseline, on 2nd ,4th and 6th week</time_frame>
      <description>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 &amp;lt;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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PERCEIVED STRESS</measure>
      <time_frame>baseline, on 2nd ,4th and 6th week</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Physical Fitness</measure>
      <time_frame>baseline, 2nd, 4th and on 6th week</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep quality</measure>
      <time_frame>baseline, 2nd, 4th and on 6th week</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Cigarette Smoking</condition>
    <arm_group>
      <arm_group_label>Deep breathing exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will perform following exercises:&#xD;
  Pursed lip breathing, Diaphragmatic breathing and powered breathing for 3-4 times a day for 6 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>No Intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will not perform any exercise.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Breathing exercises</intervention_name>
      <description>Pursed lip breathing, Diaphragmatic breathing and powered breathing</description>
      <arm_group_label>Deep breathing exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Only Male Healthy Smoker.&#xD;
  &#xD;
            -  Age: 20 - 30 years.&#xD;
  &#xD;
            -  Participants had a minimum smoking history of 5 years.&#xD;
  &#xD;
            -  Subject without any chronic pulmonary complication.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers with any pulmonary disease, acute infections, other systemic disease.&#xD;
  &#xD;
            -  Chest deformity or any disability.&#xD;
  &#xD;
            -  History of any surgery.&#xD;
  &#xD;
            -  Not willing to participate.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Only male participants</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>30 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Malik Muhammad Ali Awan, MSPT</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University, Islamabad</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Malik Muhammad Ali Awan, MSPT</last_name>
      <phone>03339131556</phone>
      <email>mmaawan@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tallyia Naz, DPT</last_name>
      <phone>03315971037</phone>
      <email>talliyanaz@gmail.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032793
  org study id: REC/MS-PT/01656 Talliya Naz
  nct id: NCT06032793
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Effects of deep breathing exercise on pulmonary function, perceived stress and physical
        fitness among healthy smokers.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Forced Vital Capacity
  time frame: baseline, on 2nd ,4th and 6th week
  description: 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.
  measure: Forced Expiratory Volume
  time frame: baseline, on 2nd ,4th and 6th week
  description: 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 &lt;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.
  measure: PERCEIVED STRESS
  time frame: baseline, on 2nd ,4th and 6th week
  description: 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.
  measure: Physical Fitness
  time frame: baseline, 2nd, 4th and on 6th week
  description: 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.
  measure: Sleep quality
  time frame: baseline, 2nd, 4th and on 6th week
  description: 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.
  arm group label: Deep breathing exercise
  arm group type: Experimental
  description: This group will perform following exercises:
  Pursed lip breathing, Diaphragmatic breathing and powered breathing for 3-4 times a day for 6 weeks.
  arm group label: No Intervention
  arm group type: No Intervention
  description: This group will not perform any exercise.
  intervention type: Other
  intervention name: Breathing exercises
  description: Pursed lip breathing, Diaphragmatic breathing and powered breathing
  arm group label: Deep breathing exercise
  criteria: 
  gender: Male
  gender based: Yes
  gender description: Only male participants
  minimum age: 20 Years
  maximum age: 30 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Malik Muhammad Ali Awan, MSPT
  role: Principal Investigator
  affiliation: Riphah International University, Islamabad
  last name: Malik Muhammad Ali Awan, MSPT
  phone: 03339131556
  email: mmaawan@gmail.com
  last name: Tallyia Naz, DPT
  phone: 03315971037
  email: talliyanaz@gmail.com
  responsible party type: Sponsor
  sharing ipd: No