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Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients (YOG-IC)

Primary Purpose

Chronic Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Yoga arm
storytelling activities
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Yoga, randomized, SF36

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Workshops around storytelling

Yoga classes

Arm Description

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.

Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Score Hospital Anxiety and Depression Scale (HAD)
Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome
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.
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.
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.
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.
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.
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
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
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
Distance during 6-minute walk test
distance traveled by the patient in 6 minutes
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
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
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
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
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

Full Information

First Posted
August 17, 2023
Last Updated
August 24, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT06019169
Brief Title
Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients
Acronym
YOG-IC
Official Title
Randomized Pilot Trial: Impact of YOGA on the Quality of Life and Well-being of Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 30, 2023 (Anticipated)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart Failure, Yoga, randomized, SF36

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study, prospective, monocentric controlled in open label, Randomization ratio 1:1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Workshops around storytelling
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Yoga classes
Arm Type
Experimental
Arm Description
Participation in YOGA classes. There are 4 sessions of 45 minutes (2 face-to-face and 2 remote) per month for 3 months.
Intervention Type
Other
Intervention Name(s)
Yoga arm
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
storytelling activities
Intervention Description
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 Measure Information:
Title
SF-36 quality of life
Description
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.
Time Frame
at day 0 and maximum at 5 month
Secondary Outcome Measure Information:
Title
Score Hospital Anxiety and Depression Scale (HAD)
Description
Self questionnaire about nervous breakdown, min=0, max=42, higher score means a worse outcome
Time Frame
at day 0 and maximum at 5 month
Title
Weight (kg)
Description
Weight measurement during the inclusion visit (1st visit) and at the last visit (2nd visit). we measure the delta between the 2 visits.
Time Frame
at day 0 and maximum at 5 month
Title
Waist circumference (cm)
Description
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.
Time Frame
at day 0 and maximum at 5 month
Title
Heart rate (Bpm)
Description
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.
Time Frame
at day 0 and maximum at 5 month
Title
Blood pressure (mmHg)
Description
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.
Time Frame
at day 0 and maximum at 5 month
Title
NYHA assessment
Description
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.
Time Frame
at day 0 and maximum at 5 month
Title
Concentration of Nt-pro BNP Biomarker
Description
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
Time Frame
3 months before inclusion and maximum 7 months after inclusion
Title
Concentration of CRP Biomarkers
Description
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
Time Frame
3 months before inclusion and maximum 7 months after inclusion
Title
Concentration IL6 Biomarkers
Description
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
Time Frame
3 months before inclusion and maximum 7 months after inclusion
Title
Distance during 6-minute walk test
Description
distance traveled by the patient in 6 minutes
Time Frame
3 months before inclusion and maximum 7 months after inclusion
Title
Peak VO2
Description
Peak VO2 measurement on two different dates to analyze the results of walk tests carried out according to the center's current practice
Time Frame
3 months before inclusion and maximum 7 months after inclusion
Title
VO2 charge level
Description
VO2 charge level on two different dates to analyze the results of walk tests carried out according to the center's current practice
Time Frame
3 months before inclusion and maximum 7 months after inclusion
Title
VE/VCO2
Description
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
Time Frame
3 months before inclusion and maximum 7 months after inclusion
Title
First ventilatory threshold
Description
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
Time Frame
3 months before inclusion and maximum 7 months after inclusion
Title
First ventilatory load level
Description
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
Time Frame
3 months before inclusion and maximum 7 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lise LEGRAND, Dr
Phone
01 42 16 30 74
Ext
+33
Email
lise.legrand@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas VIGNOLLES
Phone
01 42 16 30 30
Ext
+33
Email
nicolas.vignolles-ext@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise LEGRAND, Dr
Organizational Affiliation
Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gilles MONTALESCOT, Pr
Organizational Affiliation
Institut de Cardiologie - Hôpital La Pitié Salpêtrière (APHP)
Official's Role
Study Director
Facility Information:
Facility Name
Institut de Cardiologie, Centre Hospitalier Universitaire Pitié Salpêtrière (APHP), UPMC
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles MONTALESCOT, Pr
Phone
01 42 16 30 07
Ext
0033
Email
gilles.montalescot@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30384895
Citation
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.
Results Reference
background
PubMed Identifier
27206819
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;:
Results Reference
background
PubMed Identifier
18514933
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.
Results Reference
background
PubMed Identifier
29755216
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.
Results Reference
background
PubMed Identifier
19952833
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.
Results Reference
background
PubMed Identifier
22507552
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.
Results Reference
background
PubMed Identifier
3080166
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.
Results Reference
background
PubMed Identifier
1593914
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.
Results Reference
background
PubMed Identifier
31302043
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.
Results Reference
background
PubMed Identifier
32438483
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.
Results Reference
background
PubMed Identifier
24627449
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.
Results Reference
background
PubMed Identifier
27843045
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.
Results Reference
background
PubMed Identifier
20882358
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.
Results Reference
background

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

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