Effect of Yoga on Clinical Outcomes and Quality of Life in patients with Vasovagal Syncope. A randomized controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Yoga on the clinical outcome (Number of episodes of syncope and presyncope ) of patients with VVS over a follow-up period of one year.
研究概览
简要总结
The proposed study is a two-parallel-arm pre-preliminary phase 2 randomized controlled trial to evaluate the clinical outcomes (No. of episodes of syncope and presyncope) of patients with Vasovagal Syncope (VVS).
Based on the inclusion and exclusion criteria, the patients will be randomized to either Intervention arm or control arm.
1. Intervention arm**:** Yoga as an intervention will be given to the patient along with the standard medical therapy for the duration of one year.
The Yoga Intervention includes two phases:
***Phase 1:***Baseline to 6 months:-
There will be 14 supervised sessions for the duration of 40 minutes each (first 8 supervised sessions at Center for Integrative Medicine and Research (CIMR), AIIMS; Remaining 6 supervised sessions over a period of 6 months at CIMR or via video conferencing).
The supervised yoga intervention will be given under the guidance of an institutionally certified yoga therapist, who will also assist the participants in home-based Yoga sessions by providing video and telephonic consultations. Participants will be given booklets and will be encouraged to practice at home.
Phase 2: 6 months to 12 months:-
The participants will be advised to practice yoga at home for the duration of 40 minutes/day for at least 5 days/ week.
2. **Control arm:**The patients in control arm will receive only standard medical therapy offered at All India Institute of Medical Sciences (AIIMS), New Delhi for the same period of time.
Follow-up visits & assessment: Baseline, 6 weeks, 6 months and 12 months.
After baseline assessment, first evaluation will be done at 6 weeks [(HUTT and Holter recordings) along with the clinical events, WHO QoL BREF questionnaire & Syncope Functional Status Questionnaire (SFSQ)] and then repeat assessments with only clinical events and questionnaires at 6 months and 12 months for each patient.
NOTE: A logbook will be given to the patients to report frequency of pre-syncope and syncope episodes and adherence to yoga therapy. The compliance to yoga will be assessed telephonically and through logbook verification during scheduled visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 15.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All adults between 15-70 years of age
- •Both genders
- •Diagnosed to have VVS (HUTT positive within last 3 months)
- •At least two episode of syncope or pre-syncope event in the last 3 months prior to enrolment
- •Patients with no other cause of Syncope
- •Patients willing and able to practice Yoga at least for 40 minutes /5 days/week.
排除标准
- •Not willing or not fulfilling the criteria of inclusion
- •Practicing yoga before
- •Accelerated hypertension(> 180/110 mm Hg)
- •Any disease which is potent to cause syncope like significant arrhythmias (Atrial Fibrillation, Atrial Flutter, Ectopic Atrial Tachycardia), Mobitz Type 2, Complete Heart Block, Sinus Bradycardia(Pause > 3 sec), Sick Sinus Syndrome with AF(pause > 5 sec in awake state), Heart Failure(LVEF ≤ 35 %, > NYHA-II).
结局指标
主要结局
To evaluate the effect of Yoga on the clinical outcome (Number of episodes of syncope and presyncope ) of patients with VVS over a follow-up period of one year.
时间窗: Baseline, 6 weeks, 6 months, 12 months
次要结局
- To evaluate the effect of Yoga on the Quality of Life(QoL) in patients with Vasovagal Syncope.
- To evaluate the short-term effect of yoga in HUTT positive response in patients with Vasovagal Syncope.(Baseline, 6 weeks)
- To evaluate the effect of Yoga on Autonomic function in patients with Vasovagal Syncope.(Baseline, 6 weeks)
- Adherence of yoga practice of the patients with Vasovagal Syncope.(Baseline, 6 weeks, 6 months, 12 months)