Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients
NCT ID: NCT06019169
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2024-03-26
2027-04-26
Brief Summary
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Detailed Description
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Pilot study, prospective, monocentric controlled in open, Randomization ratio 1:1: in two parallel groups
* Arm control workshops around social activities
* 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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Workshops around social activities
Participate in workshops around social activities. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months.
storytelling activities
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.
Yoga classes
Participation in YOGA classes performed by Mme Laura BOGANI from The Blue Fish LAB Association. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months.
Yoga arm
Participation in YOGA classes performed by Mme Laura BOGANI from The Blue Fish LAB Association. 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.
Interventions
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Yoga arm
Participation in YOGA classes performed by Mme Laura BOGANI from The Blue Fish LAB Association. 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.
storytelling activities
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.
Eligibility Criteria
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Inclusion Criteria
* Chronic heart failure patient defined by: Most recent LVEF ≤50% (regardless of measurement method)
* Stabilized (last episode of acute heart failure dating back more than a month) in NYHA stage I to III dyspnoea, ambulatory, discharged from hospital for \> 1 month
* Drug treatment optimized according to the judgment of the investigator
* Ability to participate in activities as proposed (remote or face-to-face)
* Patient affiliated with a social security scheme
* Written consent to participate
Exclusion Criteria
* Current pregnancy / lactation
* Etiology of heart failure: hypertrophic cardiomyopathy, restrictive heart disease or severe curable valve disease
* Severe renal impairment GFR\<25ml/min/1.73 m2 or on dialysis.
* Persons subject to legal protection measures (guardianship, curatorship)
* Person not "receptive" to the practice of yoga
* Participation in intervention research
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Lise LEGRAND, Dr
Role: STUDY_CHAIR
Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
Gilles MONTALESCOT, Pr
Role: STUDY_DIRECTOR
Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
Locations
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Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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APHP230227
Identifier Type: -
Identifier Source: org_study_id
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