Effects of slow pranayamic breathing on Neural correlates (physiological, psychological, imaging) and cardio-physiological markers in healthy subjects:A Randomized trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To assess the shift in EEG power spectra
研究概览
简要总结
This study is designed to understand the effects of slow pranayamic breathing on reducing stress by studying the underlying mechanism of the proposed benefits on the brain and cardiac physiology along with the neuropsychological well-being of healthy participants as compared to the active control group/ comparator arm- breath awareness exercise (physiological rate). The subjects will be recruited by posting advertisements on social media and around the AIIMS hospital campus. It is a prospective, randomized, open-label, blinded endpoint, parallel assignment of 70 subjects (MRI of only 24 subjects i.e. 12 per arm will be done). The subjects will be randomized into two groups: Study intervention group- Slow pranayamic breathing and Active control group: Breath Awareness (at the physiological rate).Assessment will be made at the baseline and at 8 weeks.
This will be the first RCT with an 8-week follow-up, which may advocate improvement in healthy individuals’ perceived stress, neuro-electrophysiological and related neuro-imaging correlates, emotional/negative affect coping functional status and cardio-physiological correlates. The outcome measures will be a shift in EEG power spectra along with a reduction in scores on the perceived stress scale. The secondary outcome measures will be changes in fMRI activity, connectivity, and structural MRI measures (in a subset of subjects- 12 per arm); improvement in PANAS, STAI, SPWB, Holter, beat-to-beat blood pressure, skin conductance test and resting metabolic rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adults between 18 to 55 years Education: Secondary or higher Naïve to pranayamic or any yoga practices Willingness to participate.
排除标准
- •Any contraindications to MRI, including MRI- incompatible implants Regular use of stimulants or any other drug that affects cardiac modulation H/o any systemic illness or psychiatric illness Pregnancy Performs meditation/yoga regularly Claustrophobia.
结局指标
主要结局
To assess the shift in EEG power spectra
时间窗: Baseline assessment and 8 weeks FU
To assess stress reduction by utilizing the Perceived Stress Scale
时间窗: Baseline assessment and 8 weeks FU
次要结局
- Changes in fMRI activity (subset of subjects)(Baseline assessment and 8 weeks FU)
- Changes in fMRI connectivity (subset of subjects)(Baseline assessment and 8 weeks FU)
- Changes in structural MRI measures (subset of subjects)(Baseline assessment and 8 weeks FU)
- To assess the changes in the Positive and Negative Affect Scale (PANAS)(Baseline assessment and 8 weeks FU)
- To assess the changes in scores of STAI scale(Baseline assessment and 8 weeks FU)
- To assess the changes in the Scales of psychological well-being(Baseline assessment and 8 weeks FU)
- To evaluate the shift in autonomic nervous system parameters (Holter monitoring)(Baseline assessment and 8 weeks FU)
- To evaluate changes in beat-to-beat blood pressure(Baseline assessment and 8 weeks FU)
- To evaluate changes in the skin conductance test(Baseline assessment and 8 weeks FU)
- To evaluate changes in the resting metabolic rate(Baseline assessment and 8 weeks FU)