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

Chronic Heart Failure Clinical Trial

— YOG-IC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06019169
• Other study ID #: APHP230227
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 30, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Lise LEGRAND, Dr
• Phone: 01 42 16 30 74
• Email: lise.legrand[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: March 30, 2025
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• Yoga arm
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.
• 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.

Locations

Country	Name	City	State
France	Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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;: — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Score Hospital Anxiety and Depression Scale (HAD)	Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome	at day 0 and maximum at 5 month
Secondary	Weight (kg)	Weight measurement during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.	at day 0 and maximum at 5 month
Secondary	Waist circumference (cm)	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.	at day 0 and maximum at 5 month
Secondary	Heart rate (Bpm)	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.	at day 0 and maximum at 5 month
Secondary	Blood pressure (mmHg)	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.	at day 0 and maximum at 5 month
Secondary	NYHA assessment	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.	at day 0 and maximum at 5 month
Secondary	Concentration of Nt-pro BNP Biomarker	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	3 months before inclusion and maximum 7 months after inclusion
Secondary	Concentration of CRP Biomarkers	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	3 months before inclusion and maximum 7 months after inclusion
Secondary	Concentration IL6 Biomarkers	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	3 months before inclusion and maximum 7 months after inclusion
Secondary	Distance during 6-minute walk test	distance traveled by the patient in 6 minutes	3 months before inclusion and maximum 7 months after inclusion
Secondary	Peak VO2	Peak VO2 measurement on two different dates to analyze the results of walk tests carried out according to the center's current practice	3 months before inclusion and maximum 7 months after inclusion
Secondary	VO2 charge level	VO2 charge level on two different dates to analyze the results of walk tests carried out according to the center's current practice	3 months before inclusion and maximum 7 months after inclusion
Secondary	VE/VCO2	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	3 months before inclusion and maximum 7 months after inclusion
Secondary	First ventilatory threshold	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	3 months before inclusion and maximum 7 months after inclusion
Secondary	First ventilatory load level	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	3 months before inclusion and maximum 7 months after inclusion