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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-26

Study Completion Date

2027-04-26

Brief Summary

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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.

Detailed Description

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Study design :

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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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

storytelling activities

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Yoga arm

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient ≥18 years old
* 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

* Patients who have practiced yoga regularly (\> once a month) in the six months prior to selection.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise LEGRAND, Dr

Role: CONTACT

01 42 16 30 74 ext. +33

Nicolas VIGNOLLES

Role: CONTACT

01 42 16 30 30 ext. +33

Facility Contacts

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Gilles MONTALESCOT, Pr

Role: primary

01 42 16 30 07 ext. 0033

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.

Reference Type BACKGROUND
PMID: 30384895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27206819 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18514933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29755216 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19952833 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22507552 (View on PubMed)

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.

Reference Type BACKGROUND
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PMID: 1593914 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31302043 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32438483 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 20882358 (View on PubMed)

Other Identifiers

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APHP230227

Identifier Type: -

Identifier Source: org_study_id

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