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/NCT06022627</url>
    </required_header>
    <id_info>
      <org_study_id>1707</org_study_id>
      <nct_id>NCT06022627</nct_id>
    </id_info>
    <brief_title>EFFECT OF PRANAYAMA YOGA ON COPD</brief_title>
    <acronym>COPD</acronym>
    <official_title>EFFECT OF PRANAYAMA YOGA ON SYMPTOMS, FATIGUE AND RESPIRATORY PARAMETERS IN INDIVIDUALS WITH COPD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yeditepe University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yeditepe 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>
        The aim of the study In this study, pranayama yoga practices are the sub-dimensions of&#xD;
        respiratory parameters, symptom and disease affection level, psychosocial adjustment and&#xD;
        psychosocial adjustment in individuals with COPD. It was planned in a randomized controlled&#xD;
        manner to examine the effects of healthcare compliance, professional environment, family&#xD;
        environment, sexual relations, extended family relationships, social environment and&#xD;
        psychological pressure. Pranayama yoga practices are aimed to reduce the frequency of&#xD;
        symptoms and the level of disease exposure in individuals with COPD. Pranayama yoga practices&#xD;
        are aimed to increase psychosocial adjustment in individuals with COPD. Pranayama yoga&#xD;
        practices aim to increase compliance with health care, occupational, social and family&#xD;
        environment, sexual and extended family relationships, and psychological pressure, which are&#xD;
        the sub-dimensions of psychosocial adjustment in individuals with COPD. It is observed that&#xD;
        all the yoga practices performed have improved the pulmonary functions of individuals with&#xD;
        COPD, decrease the severity of symptoms, relieve inflammation, and increase muscle strength&#xD;
        and physical performance. It was concluded that because of yoga increases awareness in&#xD;
        patients, patients significantly reduce their level of depression and anxiety and adapt to&#xD;
        social life. Yoga improves patients' quality of life by alleviating symptoms and increasing&#xD;
        self-awareness. pranayama yoga practices are safe, home-applied, effective, cost-effective,&#xD;
        complementary to drug therapy and can be performed during pulmonary rehabilitation for&#xD;
        individuals with COPD (1-2) . The results of this study are important in guiding caregivers&#xD;
        and healthcare professionals during the holistic care of COPD individuals and in pulmonary&#xD;
        rehabilitation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Deep breathing exercises called pranayama yoga increase the oxygen and diffusion capacity of&#xD;
        the alveolar in the lungs and facilitate gas exchange (1-3). Thus, tissue perfusion&#xD;
        increases, more oxygen binds to hemoglobin and is transported (4-5).&#xD;
  &#xD;
        Material and Method Purpose and Type of Study: This study was planned as a randomized&#xD;
        controlled study to examine the effects of pranayama yoga practices on symptoms, fatigue and&#xD;
        respiratory parameters in individuals with COPD.&#xD;
  &#xD;
        Research Goals&#xD;
  &#xD;
          1. Pranayama yoga practices are aimed to increase the FEV1, FVC, FV1/FVC … parameters of&#xD;
             individuals with COPD.&#xD;
  &#xD;
          2. Pranayama yoga practices are aimed at improving the symptom level of individuals with&#xD;
             COPD.&#xD;
  &#xD;
          3. Pranayama yoga practices are aimed at reducing fatigue levels in individuals with COPD.&#xD;
  &#xD;
        Research Hypotheses H1: Pranayama yoga increases COPD respiratory parameters (FEV1, FVC,&#xD;
        FV1/FVC, PEF, FEF AND VC) H2: Pranayama yoga reduces COPD symptom level H3: Pranayama yoga&#xD;
        reduces COPD fatigue level&#xD;
  &#xD;
        Patient selection and administration The study was conducted using simple random sampling&#xD;
        method among individuals with COPD who met the inclusion criteria and voluntarily agreed to&#xD;
        participate in the study. Patients GOLD, 2021 COPD classification, disease stages of the&#xD;
        patients were determined and 66 patients with group B Stage I and Stage II COPD were included&#xD;
        in the study. The patients included in the study were numbered by identifying the patients in&#xD;
        the study and control groups using the random.org website. 66 individuals with COPD included&#xD;
        by randomization were divided into two groups as 33 (16 Stage I and 17 Stage II) study group&#xD;
        and 33 (16 Stage I and 17 Stage II) control group. According to the spirometric FEV 1 values&#xD;
        of the patients in the study and control groups, 16 patients with Stage I and 17 Stage II&#xD;
        COPD in each group were included in the study. While the routine treatment of the patients in&#xD;
        the study group continued, 20 minutes of pranayama yoga training was given to the patient and&#xD;
        his relatives by the yoga instructor (researcher), and it was planned that the patient would&#xD;
        practice pranayama yoga, which was taught for 20 minutes a day for 21 days. In addition,&#xD;
        patients will be given a training booklet detailing pranayama yoga exercises, a training&#xD;
        video, and a 21-day checklist of practicing yoga. Patients or their relatives will be called&#xD;
        every morning by phone or online communication will be established and pranayama yoga will be&#xD;
        provided. After the application is over, the patients will be visited at the hospital or at&#xD;
        their homes, and the re-interview form, COPD Assessment Test (CAT), COPD and Asthma Fatigue&#xD;
        Scale (CAFS) will be filled and pulmonary function test will be performed and checklists will&#xD;
        be taken back from the patients. The routine treatment of the control group will continue and&#xD;
        no intervention will be applied. After the data collection process of the study is completed,&#xD;
        paranayama yoga training will be given to the patients in the control group and they will be&#xD;
        advised to do it regularly for at least 21 days.&#xD;
  &#xD;
        Resources&#xD;
  &#xD;
          1. Ranjita, R., Hankey, A., Nagendra, H. R., &amp; Mohanty, S. (b2016). Yoga-based pulmonary&#xD;
             rehabilitation for the management of dyspnea in coal miners with chronic obstructive&#xD;
             pulmonary disease: a randomized controlled trial. Journal of Ayurveda and integrative&#xD;
             medicine, 7(3), 158-166.&#xD;
  &#xD;
          2. Soni, R., Munish, K., Singh, K. P., &amp; Singh, S. (2012). Study of the effect of yoga&#xD;
             training on diffusion capacity in chronic obstructive pulmonary disease patients: A&#xD;
             controlled trial. International journal of yoga, 5(2), 123.&#xD;
  &#xD;
          3. Zeng, Y., Jiang, F., Chen, Y., Chen, P., &amp; Cai, S. (2018). Exercise assessments and&#xD;
             trainings of pulmonary rehabilitation in COPD: a literature review. International&#xD;
             journal of chronic obstructive pulmonary disease, 2013-2023.&#xD;
  &#xD;
          4. Li, C., Liu, Y., Ji, Y., Xie, L., &amp; Hou, Z. (2018). Efficacy of yoga training in chronic&#xD;
             obstructive pulmonary disease patients: a systematic review and meta-analysis.&#xD;
             Complementary therapies in clinical practice, 30, 33-37. doi: 10.1016/j.ctcp.2017.11.006&#xD;
  &#xD;
          5. Pomidori, L., Campigotto, F., Amatya, T. M., Bernardi, L., &amp; Cogo, A. (2009). Efficacy&#xD;
             and tolerability of yoga breathing in patients with chronic obstructive pulmonary&#xD;
             disease: a pilot study. Journal of cardiopulmonary rehabilitation and prevention, 29(2),&#xD;
             133-137. Available at: https://insights.ovid.com/pubmed?pmid=1930523.&#xD;
  &#xD;
          6. Thokchom, S. K., Gulati, K., Ray, A., &amp; Menon, B. K. (2018). Effects of yogic&#xD;
             intervention on pulmonary functions and health status in patients of COPD and the&#xD;
             possible mechanisms. Complementary Therapies in Clinical Practice, 33, 20-26. doi:&#xD;
             10.1016/j.ctcp.2018.07.008&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 25, 2023</start_date>
    <completion_date type="Anticipated">September 20, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 16, 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>Crossover Assignment</intervention_model>
      <intervention_model_description>66 individuals with COPD included by randomization were divided into two groups as 33 (16 Stage I and 17 Stage II) study group and 33 (16 Stage I and 17 Stage II) control group.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>COPD Assesment Test (CAT)</measure>
      <time_frame>21 days</time_frame>
      <description>Assesment Test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SPIROMETER</measure>
      <time_frame>21 days</time_frame>
      <description>MIR-Spirobank Portable Spirometer</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Asthma Fatigue Scale (CAFS)</measure>
      <time_frame>21 days</time_frame>
      <description>Assesment Test</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Asthma, Chronic Obstructive Pulmonary Disease (COPD), or Chronic Lung Disease (E.G., Chronic Bronchitis and Restrictive Lung Diseases Such as Asbestosis)</condition>
    <condition>The Effect of Yoga, Paranayama Yoga Practice on Respiratory Diseases</condition>
    <arm_group>
      <arm_group_label>Pranayam Yoga Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>It was planned to use a simple random sampling method among individuals who met the research inclusion criteria and agreed to participate voluntarily in the study. During randomization; Patients in the study and control groups will be determined using the random.org site. While the routine treatment of the patients in the study group continues, 20 minutes of pranayama yoga training will be given by the yoga instructor to the patient and his relatives, and it is planned that the patient will practice pranayama yoga, which is taught for 20 minutes every day for 21 days. Patients or their relatives will be called every morning by phone or video communication will be made online and pranayama yoga will be provided. In addition, a training booklet describing pranayama yoga exercises in detail, a training video and a 21-day checklist of doing yoga will be given to the patients. function test will be done and checklists will be taken back from patients.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non-Pranayama Yoga Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The routine treatment of the control group will continue and any intervention will not be applied. After the data collection process of the study is completed, paranayama yoga training will be given to the patients in the control group and they will be advised to do it regularly for at least 21 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Pranayama Yoga</intervention_name>
      <description>Doing practice of paranayam yoga which including breathing exercises yoga-life energy</description>
      <arm_group_label>Pranayam Yoga Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Between the ages of 40-65&#xD;
  &#xD;
            -  To have been diagnosed with Stage I or Stage II COPD for at least six months&#xD;
  &#xD;
            -  Absence of any communication problem [decreased hearing, visual impairment, inability&#xD;
               to understand/speak Turkish] that would prevent participation in the research,&#xD;
  &#xD;
            -  Least literate&#xD;
  &#xD;
            -  Do not have any mental or physical disability that would prevent them from practicing&#xD;
               Pranayama Yoga.&#xD;
  &#xD;
            -  Not having done pranayama yoga before&#xD;
  &#xD;
            -  No tracheostomy&#xD;
  &#xD;
            -  Telephone communication is possible.&#xD;
  &#xD;
            -  The patients who accepted to participate in the study voluntarily constitute the&#xD;
               sample of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Being diagnosed with Stage III and Stage IV COPD,&#xD;
  &#xD;
            -  Patients under the age of 40 and not over the age of 65&#xD;
  &#xD;
            -  Individuals who are bored during the interview and give up on the interview will not&#xD;
               be included in the study and their data will not be used.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University</name>
        <address>
          <city>Istanbul</city>
          <state>Ataşehir</state>
          <zip>34758</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Selman ÇELİK, PHD</last_name>
        <phone>05423440717</phone>
        <email>selman.celik@yeditepe.edu.tr</email>
      </contact>
      <contact_backup>
        <last_name>Sıdıka OĞUZ, PROF.</last_name>
        <phone>05334651099</phone>
        <email>soguz@marmara.edu.tr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pranayama Yoga</keyword>
    <keyword>COPD</keyword>
    <keyword>Semptoms</keyword>
    <keyword>Fatigue</keyword>
    <keyword>Pulmonary functions</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bronchitis</mesh_term>
      <mesh_term>Bronchitis, Chronic</mesh_term>
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Obstructive</mesh_term>
      <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
      <mesh_term>Respiratory Tract Diseases</mesh_term>
      <mesh_term>Respiration Disorders</mesh_term>
      <mesh_term>Asbestosis</mesh_term>
    </condition_browse>
    <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/NCT06022627
  org study id: 1707
  nct id: NCT06022627
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study In this study, pranayama yoga practices are the sub-dimensions of
        respiratory parameters, symptom and disease affection level, psychosocial adjustment and
        psychosocial adjustment in individuals with COPD. It was planned in a randomized controlled
        manner to examine the effects of healthcare compliance, professional environment, family
        environment, sexual relations, extended family relationships, social environment and
        psychological pressure. Pranayama yoga practices are aimed to reduce the frequency of
        symptoms and the level of disease exposure in individuals with COPD. Pranayama yoga practices
        are aimed to increase psychosocial adjustment in individuals with COPD. Pranayama yoga
        practices aim to increase compliance with health care, occupational, social and family
        environment, sexual and extended family relationships, and psychological pressure, which are
        the sub-dimensions of psychosocial adjustment in individuals with COPD. It is observed that
        all the yoga practices performed have improved the pulmonary functions of individuals with
        COPD, decrease the severity of symptoms, relieve inflammation, and increase muscle strength
        and physical performance. It was concluded that because of yoga increases awareness in
        patients, patients significantly reduce their level of depression and anxiety and adapt to
        social life. Yoga improves patients' quality of life by alleviating symptoms and increasing
        self-awareness. pranayama yoga practices are safe, home-applied, effective, cost-effective,
        complementary to drug therapy and can be performed during pulmonary rehabilitation for
        individuals with COPD (1-2) . The results of this study are important in guiding caregivers
        and healthcare professionals during the holistic care of COPD individuals and in pulmonary
        rehabilitation.
  Deep breathing exercises called pranayama yoga increase the oxygen and diffusion capacity of
        the alveolar in the lungs and facilitate gas exchange (1-3). Thus, tissue perfusion
        increases, more oxygen binds to hemoglobin and is transported (4-5).
  
        Material and Method Purpose and Type of Study: This study was planned as a randomized
        controlled study to examine the effects of pranayama yoga practices on symptoms, fatigue and
        respiratory parameters in individuals with COPD.
  
        Research Goals
  
          1. Pranayama yoga practices are aimed to increase the FEV1, FVC, FV1/FVC … parameters of
             individuals with COPD.
  
          2. Pranayama yoga practices are aimed at improving the symptom level of individuals with
             COPD.
  
          3. Pranayama yoga practices are aimed at reducing fatigue levels in individuals with COPD.
  
        Research Hypotheses H1: Pranayama yoga increases COPD respiratory parameters (FEV1, FVC,
        FV1/FVC, PEF, FEF AND VC) H2: Pranayama yoga reduces COPD symptom level H3: Pranayama yoga
        reduces COPD fatigue level
  
        Patient selection and administration The study was conducted using simple random sampling
        method among individuals with COPD who met the inclusion criteria and voluntarily agreed to
        participate in the study. Patients GOLD, 2021 COPD classification, disease stages of the
        patients were determined and 66 patients with group B Stage I and Stage II COPD were included
        in the study. The patients included in the study were numbered by identifying the patients in
        the study and control groups using the random.org website. 66 individuals with COPD included
        by randomization were divided into two groups as 33 (16 Stage I and 17 Stage II) study group
        and 33 (16 Stage I and 17 Stage II) control group. According to the spirometric FEV 1 values
        of the patients in the study and control groups, 16 patients with Stage I and 17 Stage II
        COPD in each group were included in the study. While the routine treatment of the patients in
        the study group continued, 20 minutes of pranayama yoga training was given to the patient and
        his relatives by the yoga instructor (researcher), and it was planned that the patient would
        practice pranayama yoga, which was taught for 20 minutes a day for 21 days. In addition,
        patients will be given a training booklet detailing pranayama yoga exercises, a training
        video, and a 21-day checklist of practicing yoga. Patients or their relatives will be called
        every morning by phone or online communication will be established and pranayama yoga will be
        provided. After the application is over, the patients will be visited at the hospital or at
        their homes, and the re-interview form, COPD Assessment Test (CAT), COPD and Asthma Fatigue
        Scale (CAFS) will be filled and pulmonary function test will be performed and checklists will
        be taken back from the patients. The routine treatment of the control group will continue and
        no intervention will be applied. After the data collection process of the study is completed,
        paranayama yoga training will be given to the patients in the control group and they will be
        advised to do it regularly for at least 21 days.
  
        Resources
  
          1. Ranjita, R., Hankey, A., Nagendra, H. R., & Mohanty, S. (b2016). Yoga-based pulmonary
             rehabilitation for the management of dyspnea in coal miners with chronic obstructive
             pulmonary disease: a randomized controlled trial. Journal of Ayurveda and integrative
             medicine, 7(3), 158-166.
  
          2. Soni, R., Munish, K., Singh, K. P., & Singh, S. (2012). Study of the effect of yoga
             training on diffusion capacity in chronic obstructive pulmonary disease patients: A
             controlled trial. International journal of yoga, 5(2), 123.
  
          3. Zeng, Y., Jiang, F., Chen, Y., Chen, P., & Cai, S. (2018). Exercise assessments and
             trainings of pulmonary rehabilitation in COPD: a literature review. International
             journal of chronic obstructive pulmonary disease, 2013-2023.
  
          4. Li, C., Liu, Y., Ji, Y., Xie, L., & Hou, Z. (2018). Efficacy of yoga training in chronic
             obstructive pulmonary disease patients: a systematic review and meta-analysis.
             Complementary therapies in clinical practice, 30, 33-37. doi: 10.1016/j.ctcp.2017.11.006
  
          5. Pomidori, L., Campigotto, F., Amatya, T. M., Bernardi, L., & Cogo, A. (2009). Efficacy
             and tolerability of yoga breathing in patients with chronic obstructive pulmonary
             disease: a pilot study. Journal of cardiopulmonary rehabilitation and prevention, 29(2),
             133-137. Available at: https://insights.ovid.com/pubmed?pmid=1930523.
  
          6. Thokchom, S. K., Gulati, K., Ray, A., & Menon, B. K. (2018). Effects of yogic
             intervention on pulmonary functions and health status in patients of COPD and the
             possible mechanisms. Complementary Therapies in Clinical Practice, 33, 20-26. doi:
             10.1016/j.ctcp.2018.07.008
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: 66 individuals with COPD included by randomization were divided into two groups as 33 (16 Stage I and 17 Stage II) study group and 33 (16 Stage I and 17 Stage II) control group.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: COPD Assesment Test (CAT)
  time frame: 21 days
  description: Assesment Test
  measure: SPIROMETER
  time frame: 21 days
  description: MIR-Spirobank Portable Spirometer
  measure: Asthma Fatigue Scale (CAFS)
  time frame: 21 days
  description: Assesment Test
  arm group label: Pranayam Yoga Group
  arm group type: Experimental
  description: It was planned to use a simple random sampling method among individuals who met the research inclusion criteria and agreed to participate voluntarily in the study. During randomization; Patients in the study and control groups will be determined using the random.org site. While the routine treatment of the patients in the study group continues, 20 minutes of pranayama yoga training will be given by the yoga instructor to the patient and his relatives, and it is planned that the patient will practice pranayama yoga, which is taught for 20 minutes every day for 21 days. Patients or their relatives will be called every morning by phone or video communication will be made online and pranayama yoga will be provided. In addition, a training booklet describing pranayama yoga exercises in detail, a training video and a 21-day checklist of doing yoga will be given to the patients. function test will be done and checklists will be taken back from patients.
  arm group label: Non-Pranayama Yoga Group
  arm group type: No Intervention
  description: The routine treatment of the control group will continue and any intervention will not be applied. After the data collection process of the study is completed, paranayama yoga training will be given to the patients in the control group and they will be advised to do it regularly for at least 21 days.
  intervention type: Behavioral
  intervention name: Pranayama Yoga
  description: Doing practice of paranayam yoga which including breathing exercises yoga-life energy
  arm group label: Pranayam Yoga Group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Turkey
  responsible party type: Sponsor
  mesh term: Bronchitis
  mesh term: Bronchitis, Chronic
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  mesh term: Respiratory Tract Diseases
  mesh term: Respiration Disorders
  mesh term: Asbestosis
  sharing ipd: No