Development, Validation and Piloting of a Yoga Programme for Patients with Single Ventricle following Fontan Operation

Fontan operation or TotalCavopulmonary Connection (TCPC) is performed for a wide range of congenitalcardiac malformations that fall into the category of ‘single ventricle’ –wherein all major systemic veins (superior and inferior vena cava and thehepatic veins) are diverted to the pulmonary arteries, bypassing the rightventricular pump.(1)  Lung mechanics and vascular resistances arecrucial determinants of the clinical course after Fontan operation, withpulmonary blood flow being dependent upon the passive flow of blood fromsystemic veins into the pulmonary arteries. Poor respiratory functions,ventilation/perfusion mismatch, elevated pulmonary vascular pressures andresistances, all contribute to suboptimal hemodynamics after Fontan.(2,3)Physical activity and exercise training is routinely recommended for childrenand adults following Fontan operation.(4,5)However, the strength of the evidence behind these recommendations is low owingto various methodological limitations including small samples etc., and thesestudies were conducted in a high-income country setting which may not berelevant in resource poor settings like India.(6,7)Hence, there is a definitive need for a low-cost, culturally acceptabletailored physical activity programme in a low-resource setting like India. Yogabased cardiac rehabilitation has been shown to improve the quality of life inpatients following acute myocardial infarction and also, yoga has demonstratedits potential of clinical utility in the wide spectrum of cardiovasculardiseases.(8,9)Pilotstudies of yogic breathing has been shown to improve lung function and qualityof life  in patients with Fontancirculation.(10,11)

Hence, the specific aims are as follows

1. Aim 1 : To develop  and validate a yoga programme for patientswith single ventricle following Fontan surgery

Approach: The programme will be developed using astructured process involving a literature review and validation among experts.Yogic practices which could influencerespiratorymechanics, modulate autonomic functions, lymphatic drainage and increaseexercise capacity in various conditions including healthy volunteers, respiratorydiseases, cardiovascular diseases and lymphedema will be collated. This will befollowed by the validation of developed protocol by the expert committeecomprising experts from cardiology, paediatric cardiology and yoga.

2. Aim 2: To test the efficacy of Yoga basedCardiac rehabilitation programme in patients with single ventricle following Fontansurgery in a pilot clinical trial

Approach: We will recruit 20 patients with singleventricle following Fontan operation for a pre-post clinical trial. Thepatients will be provided intensive training in yoga (3 sessions a week) andadvised to practice 5-7 times a week for three months. The sessions will bedelivered over a virtual platform. The efficacy of the programme will beassessed by the cardiovascular and hemodynamic changes using cardiac MRI, respiratorymechanics by pulmonary function tests and psychological profile includinganxiety, depression and self-esteem.

3. Aim 3: To test the feasibility andacceptability of various yoga practices prescribed in the yoga programme

Approach: The participants in the trial will be requestedto provide information on the feasibility and acceptability of each of theindividual yoga practices prescribed every 15 days through a structuredquestionnaire. In addition, the yoga trainer will report on the ability of theparticipants to perform each of the practices every two weeks. These data willbe essential to modify the yoga programme, if required. We will also interviewthe participants and their caregivers to collect data on acceptability andfeasibility of the yoga programme.