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/NCT05979688</url>
    </required_header>
    <id_info>
      <org_study_id>IRB-300011535</org_study_id>
      <nct_id>NCT05979688</nct_id>
    </id_info>
    <brief_title>Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis</brief_title>
    <official_title>Yogic Breathing Exercise for People With Amyotrophic Lateral Sclerosis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Alabama at Birmingham</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Alabama at Birmingham</source>
    <oversight_info>
      <has_dmc>No</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 this study is to understand how well a 6-week virtual yogic breathing exercise&#xD;
        program (YBEP) will improve breathing, speech, and emotional well-being in people with&#xD;
        amyotrophic lateral sclerosis (ALS).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will employ a RCT to test the two hypotheses. The study will incorporate a 2 x 3&#xD;
        two-way factorial design with repeated measures at three time points. The two between-subject&#xD;
        factor conditions will be participation in a yogic breathing exercise program (YBEP) versus a&#xD;
        waitlist control condition that will be evaluated at baseline, immediately post-program, and&#xD;
        at 3-month follow-up. Thirty adults with ALS will be recruited for this study.&#xD;
  &#xD;
        Hypothesis #1: Adults with ALS who participate in a YBEP will demonstrate improvement in&#xD;
        breathing, speech function, and emotional well-being compared to waitlist controls at the&#xD;
        conclusion of a 6-week YBEP.&#xD;
  &#xD;
        Hypothesis #2: The positive impact of the YBEP on the participants' improved breathing,&#xD;
        speech function, and emotional well-being will be maintained at 3-month follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 28, 2025</primary_completion_date>
    <phase>Phase 2</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>
      <intervention_model_description>Randomized controlled trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Assessors are masked to participant group assignment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Forced vital capacity (FVC)</measure>
      <time_frame>baseline</time_frame>
      <description>Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Forced vital capacity (FVC)</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Forced vital capacity (FVC)</measure>
      <time_frame>at 3 months</time_frame>
      <description>Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximal inspiratory pressure (MIP)</measure>
      <time_frame>baseline</time_frame>
      <description>Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximal inspiratory pressure (MIP)</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximal inspiratory pressure (MIP)</measure>
      <time_frame>at 3 months</time_frame>
      <description>Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum expiratory pressure (MEP)</measure>
      <time_frame>baseline</time_frame>
      <description>Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum expiratory pressure (MEP)</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum expiratory pressure (MEP)</measure>
      <time_frame>at 3 months</time_frame>
      <description>Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak cough flow</measure>
      <time_frame>baseline</time_frame>
      <description>Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak cough flow</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Peak cough flow</measure>
      <time_frame>at 3 months</time_frame>
      <description>Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sentence Intelligibility Test</measure>
      <time_frame>baseline</time_frame>
      <description>Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sentence Intelligibility Test</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sentence Intelligibility Test</measure>
      <time_frame>at 3 months</time_frame>
      <description>Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Consensus Auditory-Perceptual Evaluation of Voice</measure>
      <time_frame>baseline</time_frame>
      <description>The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Consensus Auditory-Perceptual Evaluation of Voice</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Consensus Auditory-Perceptual Evaluation of Voice</measure>
      <time_frame>at 3 months</time_frame>
      <description>The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voice Handicap Index</measure>
      <time_frame>baseline</time_frame>
      <description>Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voice Handicap Index</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Voice Handicap Index</measure>
      <time_frame>at 3 months</time_frame>
      <description>Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ALS Specific Quality of Life-Revised</measure>
      <time_frame>baseline</time_frame>
      <description>ALS Specific Quality of Life-Revised (ALSSQOL-R) consists of 6 subscales: negative emotion (13 items), interaction with people and the environment (11 items), intimacy (7 items), religiosity (4 items), physical symptoms (6 items), and bulbar function (5 items). The scale has 46 items rated on a 11-point Likert-type scale (0 to 10) with higher scores indicating better quality of life. Some items require reverse scoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ALS Specific Quality of Life-Revised</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>ALS Specific Quality of Life-Revised (ALSSQOL-R) consists of 6 subscales: negative emotion (13 items), interaction with people and the environment (11 items), intimacy (7 items), religiosity (4 items), physical symptoms (6 items), and bulbar function (5 items). The scale has 46 items rated on a 11-point Likert-type scale (0 to 10) with higher scores indicating better quality of life. Some items require reverse scoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ALS Specific Quality of Life-Revised</measure>
      <time_frame>at 3 months</time_frame>
      <description>ALS Specific Quality of Life-Revised (ALSSQOL-R) consists of 6 subscales: negative emotion (13 items), interaction with people and the environment (11 items), intimacy (7 items), religiosity (4 items), physical symptoms (6 items), and bulbar function (5 items). The scale has 46 items rated on a 11-point Likert-type scale (0 to 10) with higher scores indicating better quality of life. Some items require reverse scoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ALS Depression Inventory</measure>
      <time_frame>baseline</time_frame>
      <description>ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ALS Depression Inventory</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ALS Depression Inventory</measure>
      <time_frame>at 3 months</time_frame>
      <description>ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hospital anxiety and depression scale</measure>
      <time_frame>baseline</time_frame>
      <description>Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hospital anxiety and depression scale</measure>
      <time_frame>at 6 weeks</time_frame>
      <description>Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Hospital anxiety and depression scale</measure>
      <time_frame>at 3 months</time_frame>
      <description>Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Amyotrophic Lateral Sclerosis</condition>
    <arm_group>
      <arm_group_label>Yogic breathing exercise</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participation in usual daily activities</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>yogic breathing exercise</intervention_name>
      <description>A typical session will begin with the yoga instructor demonstrating a breathing exercise technique. The participants will learn and practice each technique.</description>
      <arm_group_label>Yogic breathing exercise</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. confirmed ALS diagnosis,&#xD;
  &#xD;
            2. age &gt;18 yrs old;&#xD;
  &#xD;
            3. ability to follow multistep commands,&#xD;
  &#xD;
            4. on a stable dose of any ALS medications for &gt;60 days,&#xD;
  &#xD;
            5. FVC ≥70% predicted,&#xD;
  &#xD;
            6. Score of either 2 or 3 on the ALSFRS-R &quot;Speech&quot; subscale, and&#xD;
  &#xD;
            7. access to internet and a computer or smartphone that can perform videoconferencing.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. life expectancy is less than 6 months,&#xD;
  &#xD;
            2. severe hearing or visual impairments that prevent online learning (breathing&#xD;
               exercise), or&#xD;
  &#xD;
            3. current participation in another clinical trial during the study period that can&#xD;
               affect the outcomes of the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hon Yuen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Alabama at Birmingham</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hon Yuen, PhD</last_name>
      <phone>2059346301</phone>
      <email>yuen@uab.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Alabama at Birmingham</name>
        <address>
          <city>Birmingham</city>
          <state>Alabama</state>
          <zip>35294</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <citation>Pagnini F, Marconi A, Tagliaferri A, Manzoni GM, Gatto R, Fabiani V, Gragnano G, Rossi G, Volpato E, Banfi P, Palmieri A, Graziano F, Castelnuovo G, Corbo M, Molinari E, Riva N, Sansone V, Lunetta C. Meditation training for people with amyotrophic lateral sclerosis: a randomized clinical trial. Eur J Neurol. 2017 Apr;24(4):578-586. doi: 10.1111/ene.13246. Epub 2017 Feb 23.</citation>
      <PMID>28229508</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
      <investigator_full_name>Hon K. Yuen, PhD</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Amyotrophic Lateral Sclerosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Motor Neuron Disease</mesh_term>
      <mesh_term>Amyotrophic Lateral Sclerosis</mesh_term>
      <mesh_term>Sclerosis</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/NCT05979688
  org study id: IRB-300011535
  nct id: NCT05979688
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to understand how well a 6-week virtual yogic breathing exercise
        program (YBEP) will improve breathing, speech, and emotional well-being in people with
        amyotrophic lateral sclerosis (ALS).
  The study will employ a RCT to test the two hypotheses. The study will incorporate a 2 x 3
        two-way factorial design with repeated measures at three time points. The two between-subject
        factor conditions will be participation in a yogic breathing exercise program (YBEP) versus a
        waitlist control condition that will be evaluated at baseline, immediately post-program, and
        at 3-month follow-up. Thirty adults with ALS will be recruited for this study.
  
        Hypothesis #1: Adults with ALS who participate in a YBEP will demonstrate improvement in
        breathing, speech function, and emotional well-being compared to waitlist controls at the
        conclusion of a 6-week YBEP.
  
        Hypothesis #2: The positive impact of the YBEP on the participants' improved breathing,
        speech function, and emotional well-being will be maintained at 3-month follow-up.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized controlled trial
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Assessors are masked to participant group assignment.
  measure: Forced vital capacity (FVC)
  time frame: baseline
  description: Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath.
  measure: Forced vital capacity (FVC)
  time frame: at 6 weeks
  description: Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath.
  measure: Forced vital capacity (FVC)
  time frame: at 3 months
  description: Forced vital capacity (FVC) in % predicted value is the maximum amount of air that a person can forcefully exhale after taking the deepest breath.
  measure: Maximal inspiratory pressure (MIP)
  time frame: baseline
  description: Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm).
  measure: Maximal inspiratory pressure (MIP)
  time frame: at 6 weeks
  description: Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm).
  measure: Maximal inspiratory pressure (MIP)
  time frame: at 3 months
  description: Maximal inspiratory pressure (MIP) in cmH20 is the maximum negative pressure that a person can generate from forced inspiration. It is a measure of the strength of inspiratory muscles (i.e., the diaphragm).
  measure: Maximum expiratory pressure (MEP)
  time frame: baseline
  description: Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles)
  measure: Maximum expiratory pressure (MEP)
  time frame: at 6 weeks
  description: Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles)
  measure: Maximum expiratory pressure (MEP)
  time frame: at 3 months
  description: Maximum expiratory pressure (MEP) in cmH20 is the maximum positive pressure that a person can generate from forced expiration. It is a measure of the strength of expiratory muscles (i.e., abdominal muscles)
  measure: Peak cough flow
  time frame: baseline
  description: Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination.
  measure: Peak cough flow
  time frame: at 6 weeks
  description: Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination.
  measure: Peak cough flow
  time frame: at 3 months
  description: Peak cough flow in L/min is the maximum expiratory flow during the compressive phase of a cough. It is to assess neuromuscular activity and effective coordination.
  measure: Sentence Intelligibility Test
  time frame: baseline
  description: Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria.
  measure: Sentence Intelligibility Test
  time frame: at 6 weeks
  description: Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria.
  measure: Sentence Intelligibility Test
  time frame: at 3 months
  description: Sentence Intelligibility Test (SIT) in %words/min is to measure speech / sentence intelligibility and speaking rate for individuals with dysarthria.
  measure: The Consensus Auditory-Perceptual Evaluation of Voice
  time frame: baseline
  description: The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines.
  measure: The Consensus Auditory-Perceptual Evaluation of Voice
  time frame: at 6 weeks
  description: The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines.
  measure: The Consensus Auditory-Perceptual Evaluation of Voice
  time frame: at 3 months
  description: The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is for clinical auditory-perceptual assessment of the severity of auditory-perceptual attributes of a voice problem, which includes roughness, breathiness, strain, pitch, and loudness. They are rated on 100 mm lines.
  measure: Voice Handicap Index
  time frame: baseline
  description: Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life.
  measure: Voice Handicap Index
  time frame: at 6 weeks
  description: Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life.
  measure: Voice Handicap Index
  time frame: at 3 months
  description: Voice Handicap Index (VHI) assesses a person's perception of the severity and impact of their voice disorder upon daily life. It consists of three subscales (physical, functional, and emotional) of the impact of a voice disorder and a total impact score. The index has 30 items rated on a 5-point Likert-type scale (never=0 to always=4) to indicate how frequently a person experiences the negative effects of their voice on their life.
  measure: ALS Specific Quality of Life-Revised
  time frame: baseline
  description: ALS Specific Quality of Life-Revised (ALSSQOL-R) consists of 6 subscales: negative emotion (13 items), interaction with people and the environment (11 items), intimacy (7 items), religiosity (4 items), physical symptoms (6 items), and bulbar function (5 items). The scale has 46 items rated on a 11-point Likert-type scale (0 to 10) with higher scores indicating better quality of life. Some items require reverse scoring.
  measure: ALS Specific Quality of Life-Revised
  time frame: at 6 weeks
  description: ALS Specific Quality of Life-Revised (ALSSQOL-R) consists of 6 subscales: negative emotion (13 items), interaction with people and the environment (11 items), intimacy (7 items), religiosity (4 items), physical symptoms (6 items), and bulbar function (5 items). The scale has 46 items rated on a 11-point Likert-type scale (0 to 10) with higher scores indicating better quality of life. Some items require reverse scoring.
  measure: ALS Specific Quality of Life-Revised
  time frame: at 3 months
  description: ALS Specific Quality of Life-Revised (ALSSQOL-R) consists of 6 subscales: negative emotion (13 items), interaction with people and the environment (11 items), intimacy (7 items), religiosity (4 items), physical symptoms (6 items), and bulbar function (5 items). The scale has 46 items rated on a 11-point Likert-type scale (0 to 10) with higher scores indicating better quality of life. Some items require reverse scoring.
  measure: ALS Depression Inventory
  time frame: baseline
  description: ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring.
  measure: ALS Depression Inventory
  time frame: at 6 weeks
  description: ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring.
  measure: ALS Depression Inventory
  time frame: at 3 months
  description: ALS Depression Inventory (ADI) has 12 items rated on a 4-point scale (0=I do not agree at all to 3=I fully agree) with higher scores indicating more depressive symptoms. Some items require reverse scoring.
  measure: Hospital anxiety and depression scale
  time frame: baseline
  description: Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring.
  measure: Hospital anxiety and depression scale
  time frame: at 6 weeks
  description: Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring.
  measure: Hospital anxiety and depression scale
  time frame: at 3 months
  description: Hospital anxiety and depression scale (HADS) has 14 items rated on a 4-point scale with higher scores indicating more anxiety and depressive symptoms. Some items require reverse scoring.
  arm group label: Yogic breathing exercise
  arm group type: Experimental
  description: Participation in a 6 weekly virtual yogic breathing exercise training with 1-3 sessions per week.
  arm group label: Waitlist control
  arm group type: No Intervention
  description: Participation in usual daily activities
  intervention type: Behavioral
  intervention name: yogic breathing exercise
  description: A typical session will begin with the yoga instructor demonstrating a breathing exercise technique. The participants will learn and practice each technique.
  arm group label: Yogic breathing exercise
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Hon Yuen, PhD
  role: Principal Investigator
  affiliation: University of Alabama at Birmingham
  last name: Hon Yuen, PhD
  phone: 2059346301
  email: yuen@uab.edu
  facility: 
  country: United States
  citation: Pagnini F, Marconi A, Tagliaferri A, Manzoni GM, Gatto R, Fabiani V, Gragnano G, Rossi G, Volpato E, Banfi P, Palmieri A, Graziano F, Castelnuovo G, Corbo M, Molinari E, Riva N, Sansone V, Lunetta C. Meditation training for people with amyotrophic lateral sclerosis: a randomized clinical trial. Eur J Neurol. 2017 Apr;24(4):578-586. doi: 10.1111/ene.13246. Epub 2017 Feb 23.
  PMID: 28229508
  responsible party type: Principal Investigator
  investigator affiliation: University of Alabama at Birmingham
  investigator full name: Hon K. Yuen, PhD
  investigator title: Professor
  mesh term: Motor Neuron Disease
  mesh term: Amyotrophic Lateral Sclerosis
  mesh term: Sclerosis
  sharing ipd: No