A Randomized controlled trial to evaluate the efficacy of Yoga on Psychological and Arrhythmic outcomes of patients implanted with Implantable Cardioverter Defibrillator
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.ICDs/ CRT-Ds burden of ventricular arrhythmia will be assessed from device interrogation.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1.ICDs/ CRT-Ds burden of ventricular arrhythmia will be assessed from device interrogation.
时间窗: 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
时间窗: Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital.
3.Zung self-assessment anxiety score (SAS)
时间窗: Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital.
4.Zung self-assessment depression score (SDS)
时间窗: 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.
时间窗: Data collection will be done at baseline, 12 weeks & 6 months in person at the hospital.
次要结局
- 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))