Yoga for patients with Implantable Cardiac Devices

Phase 2

Not yet recruiting

• Conditions: Patients implanted with Implantable Cardioverter Defibrillator (ICD)

• Registration Number: CTRI/2018/08/015397
• Lead Sponsor: MINISTRY OF AYUSH

Brief Summary

Ventricular arrhythmias are an important cause of morbidity, mortality and sudden death. There is a direct co-relationship between burden of ventricular arrhythmias and total mortality. Autonomic tone plays a central role in occurrence of ventricular arrhythmias with Yoga having a profound influence on cardiovascular physiology through its effects on central neural outflow and autonomic tone. It also improves mental and psychological wellbeing through central effects on mood and emotion.  This is a prospective, randomized, controlled study designed to test the effects of yoga on psychological and arrhythmic outcomes in patients with structural heart disease. Patients with structural heart disease who have an implantable cardioverter defibrillator or a cardiac resynchronization device with defibrillator will be randomized to either Yoga Intervention (with usual care) or usual care. Patients will have periodic assessment of clinical characteristics, arrhythmia burden, psychological and quality of life parameters at baseline, 12 weeks and at end of study.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-09
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Patients between 18to 60 years of age 2.ICD implanted at least 8 weeks prior 3.Willing to participate in Yoga 4.NYHA Class I or II symptoms 5.Deemed ready to participate by their physician.

Exclusion Criteria

1.Contraindications to Yoga 2.Advanced heart failure (NYHA Class III/IV) 3.Pregnancy 4.Patients already practicing regular Yoga or receiving any other alternative medicine for the same desired effect.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.ICDs/ CRT-Ds burden of ventricular arrhythmia will be assessed from device interrogation.	Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital.
2.Florida Shock Anxiety Scale (FSAS) will be used to access the shock anxiety	Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital.
3.Zung self-assessment anxiety score (SAS)	Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital.
4.Zung self-assessment depression score (SDS)	Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital.
5.Quality of Life outcomes will be measured using the WHO QoL BREF questionnaire.	Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital.

Secondary Outcome Measures

Name	Time	Method
1.Florida Patient Acceptance Survey (FPAS) will be used to access the acceptance of the ICD device by the patient	2.Mental stress will be assessed using the Perceived Stress Scale (PSS)

Trial Locations

Locations (1)

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI; 🇮🇳 Delhi, DELHI, India

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

🇮🇳Delhi, DELHI, India

Dr Nitish Naik

Principal investigator

01126593218

nitishnaik@yahoo.co.in