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

Official title

Randomized Pilot Trial: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients

Overview

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

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).

Interventions

• Other 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.
• 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.

Primary outcome measures

• SF-36 quality of life [Time frame: at day 0 and maximum at 5 month]

Secondary outcome measures (12)

• Score Hospital Anxiety and Depression Scale (HAD) [Time frame: at day 0 and maximum at 5 month]
• Weight (kg) [Time frame: at day 0 and maximum at 5 month]
• Waist circumference (cm) [Time frame: at day 0 and maximum at 5 month]
• Heart rate (Bpm) [Time frame: at day 0 and maximum at 5 month]
• Blood pressure (mmHg) [Time frame: at day 0 and maximum at 5 month]
• NYHA assessment [Time frame: at day 0 and maximum at 5 month]
• Concentration of Nt-pro BNP Biomarker [Time frame: 3 months before inclusion and maximum 7 months after inclusion]
• Concentration of CRP Biomarkers [Time frame: 3 months before inclusion and maximum 7 months after inclusion]
• Concentration IL6 Biomarkers [Time frame: 3 months before inclusion and maximum 7 months after inclusion]
• Distance during 6-minute walk test [Time frame: 3 months before inclusion and maximum 7 months after inclusion]
• Peak VO2 [Time frame: 3 months before inclusion and maximum 7 months after inclusion]
• VO2 charge level [Time frame: 3 months before inclusion and maximum 7 months after inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 1 center

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

Publications

• 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
• 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 PMID 27206819
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06019169 · APHP230227

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗