Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

NCT06019169 | Recruiting

• 1 other identifier: APHP230227
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; Yoga; randomized; SF36

Outcome Measures

Primary Outcomes (1)

• SF-36 quality of life

  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.

  at day 0 and maximum at 5 month

Secondary Outcomes (15)

• Score Hospital Anxiety and Depression Scale (HAD)

  at day 0 and maximum at 5 month

• Weight (kg)

  at day 0 and maximum at 5 month

• Waist circumference (cm)

  at day 0 and maximum at 5 month

• Heart rate (Bpm)

  at day 0 and maximum at 5 month

• Blood pressure (mmHg)

  at day 0 and maximum at 5 month

Study Arms (2)

Workshops around social activities

ACTIVE COMPARATOR

Participate in workshops around social activities. 4 sessions are planned (2 face-to-face and 2 remotely) per month for 3 months.

Other: storytelling activities

Yoga classes

EXPERIMENTAL

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.

Other: Yoga arm

Interventions

Yoga arm 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.

Yoga classes

storytelling activities 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.

Workshops around social activities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC

Paris, 75013, France

RECRUITING

Related Publications (13)

• 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.

  PMID: 30384895 BACKGROUND

• 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.

  PMID: 27206819 BACKGROUND

• 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.

  PMID: 18514933 BACKGROUND

• 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.

  PMID: 29755216 BACKGROUND

• 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.

  PMID: 19952833 BACKGROUND

• 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.

  PMID: 22507552 BACKGROUND

• 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.

  PMID: 3080166 BACKGROUND

• 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.

  PMID: 1593914 BACKGROUND

• 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.

  PMID: 31302043 BACKGROUND

• 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.

  PMID: 32438483 BACKGROUND

• 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.

  PMID: 24627449 BACKGROUND

• 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.

  PMID: 27843045 BACKGROUND

• 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.

  PMID: 20882358 BACKGROUND

Study Officials

• Lise LEGRAND, Dr

  Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)

  STUDY CHAIR

• Gilles MONTALESCOT, Pr

  Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)

  STUDY DIRECTOR

Central Study Contacts

Lise LEGRAND, Dr

CONTACT

01 42 16 30 74; lise.legrand@aphp.fr

Nicolas VIGNOLLES

CONTACT

01 42 16 30 30; nicolas.vignolles-ext@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 31, 2023
• Study Start: March 26, 2024
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): April 26, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)