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Yoga for patients with Implantable Cardiac Devices

A Randomized controlled trial to evaluate the efficacy of Yoga on Psychological and Arrhythmic outcomes of patients implanted with Implantable Cardioverter Defibrillator

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/08/015397
Enrollment
100
Registered
2018-08-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patients implanted with Implantable Cardioverter Defibrillator (ICD)

Interventions

Intervention1: YOGA: Yoga intervention will be performed at the Centre for Integrative Medicine and Research (CIMR) at AIIMS, New Delhi. Along with the standard medical therapy, patients assigned to t

Sponsors

MINISTRY OF AYUSH
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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) 3. A log book will be used to evaluate the frequency of hospital visit and need of drug regimen modification Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Nitish Naik

All india institute of medical sciences

nitishnaik@yahoo.co.in01126593218

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026