<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/NCT02233114</url>
  </required_header>
  <id_info>
    <org_study_id>DNR2011/248-31/1</org_study_id>
    <nct_id>NCT02233114</nct_id>
  </id_info>
  <brief_title>Is Patients With Pulmonary Disease Benefit a Program With Yogic Exercises?</brief_title>
  <official_title>Subjective and Objective Effects After Yogic Exercises</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Is Yogic Exercises (12 weeks) increasing respiratory function, functional capacity and&#xD;
      quality of life in patients with obstructive lung diseases. With follow up after 6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Is Yogic Exercises increasing respiratory function in patients with obstructive lung&#xD;
      diseases. Will YE improve respiratory muscle strength, functional capacity, inspiratory and&#xD;
      expiratory pressure, lung function, perceived dyspnea, dyspnea-related distress (DD), less&#xD;
      frequency of dyspnea and heart rate variability in patients with pulmonary disease.&#xD;
      Qualitative content analysis will be performed on approximately 15 interviews with patients&#xD;
      participated in the yoga group about their experiences and their benefits&#xD;
      perceived/experienced of the yogic exercises&#xD;
&#xD;
      We want to try YE as an alternative treatment in patients with mild to severe pulmonary&#xD;
      disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dyspnea related distress (DD)</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>6 minutes Walking test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Spirometry, Vital capacity</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation (periphery)</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiration rate</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>Measured manually</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRQ, Chronic respiratory disease questionnaire</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS- scale - perceived health</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>Scoring between 0 (worst possible) and 10 (best possible)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximal inspiratory and maximal expiratory pressure</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>Will be measured using PSS-14 scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>Measured with Pittsburgh sleep questionnaire index scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and depression</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>Measured with HADS-scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self rated health</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective complaints (perceived symptoms)</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight and height</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health behaviour</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>Measured with public health questionnaire (Folkhälsoenkäten in Swedish)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exercise diary</measure>
    <time_frame>Patients will be followed 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry, forced vital capacity (FVC)</measure>
    <time_frame>Patients will be followed for 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry, Forced expiratory volume</measure>
    <time_frame>Patients will be followed for 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry, Forced expiratory volume in one second (FEV1)</measure>
    <time_frame>Patients will be followed for 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry, Ratio between forced expiratory volume in 1 second and forced vital capacity</measure>
    <time_frame>Patients will be followed for 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spirometry, peak expiratory flow (PEF)</measure>
    <time_frame>Patients will be followed for 10-12 weeks, with follow-up after 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia</measure>
    <time_frame>Patients will be followed for 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>Measured with insomnia index scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Patients will be followed for 10-12 weeks, with follow-up after 6 months</time_frame>
    <description>Measured with Polar heart rate monitor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative content analysis</measure>
    <time_frame>After Yoga intervention - one interview, with follow-up after 6 months</time_frame>
    <description>Inteviews with participants in yoga Group, and at follow-up also physiotherapy group</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>COPD</condition>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Yogic exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Yogic exercises for lung disorders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>physiotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physiotherapy during the yogic exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yogic exercises</intervention_name>
    <description>Yogic exercises (YE) - 2 hours per week, 1h in each session</description>
    <arm_group_label>Yogic exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiotherapy</intervention_name>
    <description>Physiotherapy (low intensity cardiovascular training and strength training) - 2 hours per week, 1 h in each session</description>
    <arm_group_label>physiotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mild to severe pulmonary obstructions according to GOLD 1-3 (Global Initiative for&#xD;
             Chronic Obstructive Lung Disease),&#xD;
&#xD;
          -  FEV (forced expiratory volume) in one second (FEV1) % of predicted respiratory&#xD;
             function (30% ≤ FEV1 ≤ 90%)&#xD;
&#xD;
          -  FEV1/FVC &lt; 0.70 (&lt;65 over 65 yrs). *FVC=forced vital capacity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe neurological, orthopedic or rheumatologic injuries&#xD;
&#xD;
          -  Severely decreased thorax mobility and lung function.&#xD;
&#xD;
          -  Severe lung diseases&#xD;
&#xD;
          -  Other chronic diseases that will interfere with performance.&#xD;
&#xD;
          -  Under 200 meters on the 6MWT&#xD;
&#xD;
          -  Acute dyspnea&#xD;
&#xD;
          -  Surgery within 6 months&#xD;
&#xD;
          -  Medication affecting attention, sudden change of medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Per Wändell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet, Stockholm</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University hospital</name>
      <address>
        <city>Stockholm</city>
        <state>Huddinge</state>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>January 27, 2016</last_update_submitted>
  <last_update_submitted_qc>January 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Per Wandell</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02233114
org study id: DNR2011/248-31/1
nct id: NCT02233114
lead sponsor: 
has dmc: No
Is Yogic Exercises (12 weeks) increasing respiratory function, functional capacity and
      quality of life in patients with obstructive lung diseases. With follow up after 6 months.
Is Yogic Exercises increasing respiratory function in patients with obstructive lung
      diseases. Will YE improve respiratory muscle strength, functional capacity, inspiratory and
      expiratory pressure, lung function, perceived dyspnea, dyspnea-related distress (DD), less
      frequency of dyspnea and heart rate variability in patients with pulmonary disease.
      Qualitative content analysis will be performed on approximately 15 interviews with patients
      participated in the yoga group about their experiences and their benefits
      perceived/experienced of the yogic exercises

      We want to try YE as an alternative treatment in patients with mild to severe pulmonary
      disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Dyspnea related distress (DD)
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Functional capacity
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
description: 6 minutes Walking test
measure: Spirometry, Vital capacity
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Oxygen saturation (periphery)
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Respiration rate
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
description: Measured manually
measure: CRQ, Chronic respiratory disease questionnaire
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: VAS- scale - perceived health
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
description: Scoring between 0 (worst possible) and 10 (best possible)
measure: Maximal inspiratory and maximal expiratory pressure
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Perceived stress
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
description: Will be measured using PSS-14 scale
measure: Sleep quality
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
description: Measured with Pittsburgh sleep questionnaire index scale
measure: Anxiety and depression
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
description: Measured with HADS-scale
measure: Self rated health
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Subjective complaints (perceived symptoms)
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Blood pressure
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Weight and height
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Health behaviour
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
description: Measured with public health questionnaire (Folkhälsoenkäten in Swedish)
measure: Exercise diary
time frame: Patients will be followed 10-12 weeks, with follow-up after 6 months
measure: Spirometry, forced vital capacity (FVC)
time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Spirometry, Forced expiratory volume
time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Spirometry, Forced expiratory volume in one second (FEV1)
time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Spirometry, Ratio between forced expiratory volume in 1 second and forced vital capacity
time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Spirometry, peak expiratory flow (PEF)
time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
measure: Insomnia
time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
description: Measured with insomnia index scale
measure: Heart rate variability
time frame: Patients will be followed for 10-12 weeks, with follow-up after 6 months
description: Measured with Polar heart rate monitor
measure: Qualitative content analysis
time frame: After Yoga intervention - one interview, with follow-up after 6 months
description: Inteviews with participants in yoga Group, and at follow-up also physiotherapy group
arm group label: Yogic exercises
arm group type: Experimental
description: Yogic exercises for lung disorders
arm group label: physiotherapy
arm group type: Active Comparator
description: Physiotherapy during the yogic exercises
intervention type: Other
intervention name: Yogic exercises
description: Yogic exercises (YE) - 2 hours per week, 1h in each session
arm group label: Yogic exercises
intervention type: Other
intervention name: Physiotherapy
description: Physiotherapy (low intensity cardiovascular training and strength training) - 2 hours per week, 1 h in each session
arm group label: physiotherapy
criteria: 
gender: All
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: No
last name: Per Wändell, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet, Stockholm
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Per Wandell
investigator title: Professor