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/NCT06019169</url>
    </required_header>
    <id_info>
      <org_study_id>APHP230227</org_study_id>
      <nct_id>NCT06019169</nct_id>
    </id_info>
    <brief_title>Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients</brief_title>
    <acronym>YOG-IC</acronym>
    <official_title>Randomized Pilot Trial: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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>
        Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is&#xD;
        often accompanied by anxiety and depression symptoms that can contribute to poor treatment&#xD;
        compliance. The overall management of heart failure is currently part of the recommendations&#xD;
        and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes&#xD;
        (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is&#xD;
        an ancient practice, known to improve the emotional and physical well-being of individuals.&#xD;
        There is no formal medical contraindication to this practice, which can be perfectly adapted&#xD;
        to the patient's condition. However, very few patients with heart failure practice yoga. A&#xD;
        few randomized trials with small numbers as well as the combined analysis of several studies&#xD;
        have shown the benefit of yoga in heart failure. The main objective of the research is to&#xD;
        demonstrate the improvement in the quality of life induced by the regular practice of yoga in&#xD;
        the management of stabilized chronic heart failure patients. Secondly, we will evaluate the&#xD;
        effectiveness of regular yoga practice on improving the clinical condition of chronic heart&#xD;
        failure patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design :&#xD;
  &#xD;
        Pilot study, prospective, monocentric controlled in open, Randomization ratio 1:1: in two&#xD;
        parallel groups&#xD;
  &#xD;
          -  Arm control workshops around storytelling&#xD;
  &#xD;
          -  Yoga arm (Y): Participation in YOGA classes. There are 4 sessions of 45 minutes (2&#xD;
             face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed&#xD;
             at each session.&#xD;
  &#xD;
        Population concerned :&#xD;
  &#xD;
        Patients with stabilized chronic heart failure (last episode of acute heart failure dating&#xD;
        back more than a month) followed at the Pitié Salpêtrière cardiology institut&#xD;
  &#xD;
        The study may be offered to any stabilized heart failure patient followed in the study&#xD;
        centre. Visit V1 (D0): Information, Inclusion and randomization Visit V2 (M3): final visit.&#xD;
        Between V1 and V2: weekly workshop sessions around storytelling (arm C) or Hatha yoga (Arm&#xD;
        Y).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 30, 2024</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>
      <intervention_model_description>Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>SF-36 quality of life</measure>
      <time_frame>at day 0 and maximum at 5 month</time_frame>
      <description>The SF-36 quality of life self-questionnaire is one of the most widely used questionnaires to assess the quality of life of patients. Its result is between 0 and 100. It includes a physical summary score and a psychological summary score.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Score Hospital Anxiety and Depression Scale (HAD)</measure>
      <time_frame>at day 0 and maximum at 5 month</time_frame>
      <description>Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight (kg)</measure>
      <time_frame>at day 0 and maximum at 5 month</time_frame>
      <description>Weight measurement during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference (cm)</measure>
      <time_frame>at day 0 and maximum at 5 month</time_frame>
      <description>Measurement of the waist circumference during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate (Bpm)</measure>
      <time_frame>at day 0 and maximum at 5 month</time_frame>
      <description>Measurement of the heart rate during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure (mmHg)</measure>
      <time_frame>at day 0 and maximum at 5 month</time_frame>
      <description>Measurement of blood pressure during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NYHA assessment</measure>
      <time_frame>at day 0 and maximum at 5 month</time_frame>
      <description>Definition of the stage of heart failure by the NHYA classification at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of Nt-pro BNP Biomarker</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>Analysis of Nt-pro BNP biomarkers at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of CRP Biomarkers</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>Analysis of CRP biomarkers at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration IL6 Biomarkers</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>Analysis of IL6 biomarkers during the inclusion visit (1st visit) and the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distance during 6-minute walk test</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>distance traveled by the patient in 6 minutes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak VO2</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>Peak VO2 measurement on two different dates to analyze the results of walk tests carried out according to the center's current practice</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VO2 charge level</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>VO2 charge level on two different dates to analyze the results of walk tests carried out according to the center's current practice</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VE/VCO2</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>Measurement of the VE/VCO2 ratio on two different dates to analyze the results of the walk tests carried out according to the current practice of the center</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First ventilatory threshold</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>Measurement of the first ventilatory threshold on two different dates to analyze the results of the walking tests carried out according to the current practice of the center</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First ventilatory load level</measure>
      <time_frame>3 months before inclusion and maximum 7 months after inclusion</time_frame>
      <description>Measurement of the first ventilatory level of load on two different dates to analyze the results of the walking tests carried out according to the current practice of the center</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Chronic Heart Failure</condition>
    <arm_group>
      <arm_group_label>Workshops around storytelling</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participate in workshops around storytelling led by the association of storytellers &quot;l'Age D'or&quot;. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Yoga classes</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Yoga arm</intervention_name>
      <description>Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed at each session.</description>
      <arm_group_label>Yoga classes</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>storytelling activities</intervention_name>
      <description>Participate in workshops around storytelling led by the association of storytellers l'Age D'or. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months. An attendance sheet will be completed at each session.</description>
      <arm_group_label>Workshops around storytelling</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient ≥18 years old&#xD;
  &#xD;
            -  Chronic heart failure patient defined by: Most recent LVEF ≤50% (regardless of&#xD;
               measurement method)&#xD;
  &#xD;
            -  Stabilized (last episode of acute heart failure dating back more than a month) in NYHA&#xD;
               stage I to III dyspnoea, ambulatory, discharged from hospital for &gt; 1 month&#xD;
  &#xD;
            -  Drug treatment optimized according to the judgment of the investigator&#xD;
  &#xD;
            -  Ability to participate in activities as proposed (remote or face-to-face)&#xD;
  &#xD;
            -  Patient affiliated with a social security scheme&#xD;
  &#xD;
            -  Written consent to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have practiced yoga regularly (&gt; once a month) in the six months prior to&#xD;
               selection.&#xD;
  &#xD;
            -  Current pregnancy / lactation&#xD;
  &#xD;
            -  Etiology of heart failure: hypertrophic cardiomyopathy, restrictive heart disease or&#xD;
               severe curable valve disease&#xD;
  &#xD;
            -  Severe renal impairment GFR&lt;25ml/min/1.73 m2 or on dialysis.&#xD;
  &#xD;
            -  Persons subject to legal protection measures (guardianship, curatorship)&#xD;
  &#xD;
            -  Person not &quot;receptive&quot; to the practice of yoga&#xD;
  &#xD;
            -  Participation in intervention research&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lise LEGRAND, Dr</last_name>
      <role>Study Chair</role>
      <affiliation>Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Gilles MONTALESCOT, Pr</last_name>
      <role>Study Director</role>
      <affiliation>Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lise LEGRAND, Dr</last_name>
      <phone>01 42 16 30 74</phone>
      <phone_ext>+33</phone_ext>
      <email>lise.legrand@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Nicolas VIGNOLLES</last_name>
      <phone>01 42 16 30 30</phone>
      <phone_ext>+33</phone_ext>
      <email>nicolas.vignolles-ext@aphp.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC</name>
        <address>
          <city>Paris</city>
          <zip>75013</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Gilles MONTALESCOT, Pr</last_name>
        <phone>01 42 16 30 07</phone>
        <phone_ext>0033</phone_ext>
        <email>gilles.montalescot@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <reference>
      <citation>Aggarwal M, Bozkurt B, Panjrath G, Aggarwal B, Ostfeld RJ, Barnard ND, Gaggin H, Freeman AM, Allen K, Madan S, Massera D, Litwin SE; American College of Cardiology's Nutrition and Lifestyle Committee of the Prevention of Cardiovascular Disease Council. Lifestyle Modifications for Preventing and Treating Heart Failure. J Am Coll Cardiol. 2018 Nov 6;72(19):2391-2405. doi: 10.1016/j.jacc.2018.08.2160.</citation>
      <PMID>30384895</PMID>
    </reference>
    <reference>
      <citation>Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2016 Dec 30;:</citation>
      <PMID>27206819</PMID>
    </reference>
    <reference>
      <citation>Pullen PR, Nagamia SH, Mehta PK, Thompson WR, Benardot D, Hammoud R, Parrott JM, Sola S, Khan BV. Effects of yoga on inflammation and exercise capacity in patients with chronic heart failure. J Card Fail. 2008 Jun;14(5):407-13. doi: 10.1016/j.cardfail.2007.12.007. Epub 2008 May 27.</citation>
      <PMID>18514933</PMID>
    </reference>
    <reference>
      <citation>Pullen PR, Seffens WS, Thompson WR. Yoga for Heart Failure: A Review and Future Research. Int J Yoga. 2018 May-Aug;11(2):91-98. doi: 10.4103/ijoy.IJOY_24_17.</citation>
      <PMID>29755216</PMID>
    </reference>
    <reference>
      <citation>Pullen PR, Thompson WR, Benardot D, Brandon LJ, Mehta PK, Rifai L, Vadnais DS, Parrott JM, Khan BV. Benefits of yoga for African American heart failure patients. Med Sci Sports Exerc. 2010 Apr;42(4):651-7. doi: 10.1249/MSS.0b013e3181bf24c4.</citation>
      <PMID>19952833</PMID>
    </reference>
    <reference>
      <citation>Diez-Quevedo C, Lupon J, Gonzalez B, Urrutia A, Cano L, Cabanes R, Altimir S, Coll R, Pascual T, de Antonio M, Bayes-Genis A. Depression, antidepressants, and long-term mortality in heart failure. Int J Cardiol. 2013 Aug 20;167(4):1217-25. doi: 10.1016/j.ijcard.2012.03.143. Epub 2012 Apr 14.</citation>
      <PMID>22507552</PMID>
    </reference>
    <reference>
      <citation>Snaith RP, Zigmond AS. The hospital anxiety and depression scale. Br Med J (Clin Res Ed). 1986 Feb 1;292(6516):344. doi: 10.1136/bmj.292.6516.344. No abstract available.</citation>
      <PMID>3080166</PMID>
    </reference>
    <reference>
      <citation>Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.</citation>
      <PMID>1593914</PMID>
    </reference>
    <reference>
      <citation>Chandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.</citation>
      <PMID>31302043</PMID>
    </reference>
    <reference>
      <citation>Galinier M, Roubille F, Berdague P, Brierre G, Cantie P, Dary P, Ferradou JM, Fondard O, Labarre JP, Mansourati J, Picard F, Ricci JE, Salvat M, Tartiere L, Ruidavets JB, Bongard V, Delval C, Lancman G, Pasche H, Ramirez-Gil JF, Pathak A; OSICAT Investigators. Telemonitoring versus standard care in heart failure: a randomised multicentre trial. Eur J Heart Fail. 2020 Jun;22(6):985-994. doi: 10.1002/ejhf.1906. Epub 2020 Jun 15.</citation>
      <PMID>32438483</PMID>
    </reference>
    <reference>
      <citation>Nolte K, Herrmann-Lingen C, Wachter R, Gelbrich G, Dungen HD, Duvinage A, Hoischen N, von Oehsen K, Schwarz S, Hasenfuss G, Halle M, Pieske B, Edelmann F. Effects of exercise training on different quality of life dimensions in heart failure with preserved ejection fraction: the Ex-DHF-P trial. Eur J Prev Cardiol. 2015 May;22(5):582-93. doi: 10.1177/2047487314526071. Epub 2014 Mar 13.</citation>
      <PMID>24627449</PMID>
    </reference>
    <reference>
      <citation>Giuliano C, Karahalios A, Neil C, Allen J, Levinger I. The effects of resistance training on muscle strength, quality of life and aerobic capacity in patients with chronic heart failure - A meta-analysis. Int J Cardiol. 2017 Jan 15;227:413-423. doi: 10.1016/j.ijcard.2016.11.023. Epub 2016 Nov 7.</citation>
      <PMID>27843045</PMID>
    </reference>
    <reference>
      <citation>Peyre H, Leplege A, Coste J. Missing data methods for dealing with missing items in quality of life questionnaires. A comparison by simulation of personal mean score, full information maximum likelihood, multiple imputation, and hot deck techniques applied to the SF-36 in the French 2003 decennial health survey. Qual Life Res. 2011 Mar;20(2):287-300. doi: 10.1007/s11136-010-9740-3. Epub 2010 Oct 1.</citation>
      <PMID>20882358</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic Heart Failure</keyword>
    <keyword>Yoga</keyword>
    <keyword>randomized</keyword>
    <keyword>SF36</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Failure</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/NCT06019169
  org study id: APHP230227
  nct id: NCT06019169
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is
        often accompanied by anxiety and depression symptoms that can contribute to poor treatment
        compliance. The overall management of heart failure is currently part of the recommendations
        and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes
        (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is
        an ancient practice, known to improve the emotional and physical well-being of individuals.
        There is no formal medical contraindication to this practice, which can be perfectly adapted
        to the patient's condition. However, very few patients with heart failure practice yoga. A
        few randomized trials with small numbers as well as the combined analysis of several studies
        have shown the benefit of yoga in heart failure. The main objective of the research is to
        demonstrate the improvement in the quality of life induced by the regular practice of yoga in
        the management of stabilized chronic heart failure patients. Secondly, we will evaluate the
        effectiveness of regular yoga practice on improving the clinical condition of chronic heart
        failure patients.
  Study design :
  
        Pilot study, prospective, monocentric controlled in open, Randomization ratio 1:1: in two
        parallel groups
  
          -  Arm control workshops around storytelling
  
          -  Yoga arm (Y): Participation in YOGA classes. There are 4 sessions of 45 minutes (2
             face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed
             at each session.
  
        Population concerned :
  
        Patients with stabilized chronic heart failure (last episode of acute heart failure dating
        back more than a month) followed at the Pitié Salpêtrière cardiology institut
  
        The study may be offered to any stabilized heart failure patient followed in the study
        centre. Visit V1 (D0): Information, Inclusion and randomization Visit V2 (M3): final visit.
        Between V1 and V2: weekly workshop sessions around storytelling (arm C) or Hatha yoga (Arm
        Y).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: SF-36 quality of life
  time frame: at day 0 and maximum at 5 month
  description: The SF-36 quality of life self-questionnaire is one of the most widely used questionnaires to assess the quality of life of patients. Its result is between 0 and 100. It includes a physical summary score and a psychological summary score.
  measure: Score Hospital Anxiety and Depression Scale (HAD)
  time frame: at day 0 and maximum at 5 month
  description: Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome
  measure: Weight (kg)
  time frame: at day 0 and maximum at 5 month
  description: Weight measurement during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
  measure: Waist circumference (cm)
  time frame: at day 0 and maximum at 5 month
  description: Measurement of the waist circumference during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
  measure: Heart rate (Bpm)
  time frame: at day 0 and maximum at 5 month
  description: Measurement of the heart rate during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
  measure: Blood pressure (mmHg)
  time frame: at day 0 and maximum at 5 month
  description: Measurement of blood pressure during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
  measure: NYHA assessment
  time frame: at day 0 and maximum at 5 month
  description: Definition of the stage of heart failure by the NHYA classification at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
  measure: Concentration of Nt-pro BNP Biomarker
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: Analysis of Nt-pro BNP biomarkers at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center
  measure: Concentration of CRP Biomarkers
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: Analysis of CRP biomarkers at the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center
  measure: Concentration IL6 Biomarkers
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: Analysis of IL6 biomarkers during the inclusion visit (1st visit) and the last visit (2nd visit). we measure the delta between the 2 visits. They will be used to analyze the results of the assessments carried out according to the current practice of the center
  measure: Distance during 6-minute walk test
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: distance traveled by the patient in 6 minutes
  measure: Peak VO2
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: Peak VO2 measurement on two different dates to analyze the results of walk tests carried out according to the center's current practice
  measure: VO2 charge level
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: VO2 charge level on two different dates to analyze the results of walk tests carried out according to the center's current practice
  measure: VE/VCO2
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: Measurement of the VE/VCO2 ratio on two different dates to analyze the results of the walk tests carried out according to the current practice of the center
  measure: First ventilatory threshold
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: Measurement of the first ventilatory threshold on two different dates to analyze the results of the walking tests carried out according to the current practice of the center
  measure: First ventilatory load level
  time frame: 3 months before inclusion and maximum 7 months after inclusion
  description: Measurement of the first ventilatory level of load on two different dates to analyze the results of the walking tests carried out according to the current practice of the center
  arm group label: Workshops around storytelling
  arm group type: Active Comparator
  description: Participate in workshops around storytelling led by the association of storytellers "l'Age D'or". 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months.
  arm group label: Yoga classes
  arm group type: Experimental
  description: Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months.
  intervention type: Other
  intervention name: Yoga arm
  description: Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months. An attendance sheet will be completed at each session.
  arm group label: Yoga classes
  intervention type: Other
  intervention name: storytelling activities
  description: Participate in workshops around storytelling led by the association of storytellers l'Age D'or. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months. An attendance sheet will be completed at each session.
  arm group label: Workshops around storytelling
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lise LEGRAND, Dr
  role: Study Chair
  affiliation: Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
  last name: Gilles MONTALESCOT, Pr
  role: Study Director
  affiliation: Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
  last name: Lise LEGRAND, Dr
  phone: 01 42 16 30 74
  phone ext: +33
  email: lise.legrand@aphp.fr
  last name: Nicolas VIGNOLLES
  phone: 01 42 16 30 30
  phone ext: +33
  email: nicolas.vignolles-ext@aphp.fr
  facility: 
  contact: 
  country: France
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  responsible party type: Sponsor
  mesh term: Heart Failure
  sharing ipd: No