Non-Invasive Vagus Nerve Stimulation Combined with Diaphragmatic Aspiration Technique and Diaphragmatic Scoop Technique: A Comparative Analysis Among College Students with Bronchial Asthma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Inspiratory Capacity and Expiratory Flow
研究概览
简要总结
This study is designed to investigate and compare the therapeutic effectiveness of non-invasive vagus nerve stimulation combined with diaphragmatic aspiration versus the diaphragmatic scoop technique in mitigating dynamic hyperinflation and managing acute asthma exacerbations among medical college students with clinically diagnosed bronchial asthma. The primary objective is to determine the comparative efficacy of these interventions in optimizing asthma management within this cohort. Furthermore, the study aims to assess the effects of non-invasive vagus nerve stimulation on the control of acute exacerbations and to elucidate its relative benefits over diaphragmatic aspiration and the diaphragmatic scoop technique in reducing dynamic hyperinflation. Primary outcome measures will include comprehensive respiratory function assessments, specifically inspiratory capacity, peak expiratory flow rate, and flow-volume loop analysis, alongside evaluation of dyspnea severity using the Modified Medical Research Council (MMRC) scale. Secondary outcomes will involve assessing the frequency of asthma exacerbation recurrence utilizing the Asthma Control Test (ACT) and Asthma Control Questionnaire (ACQ), as well as determining the impact of interventions on health-related quality of life through the Asthma Quality of Life Questionnaire (AQLQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- All
入选标准
- •College Students with clinically diagnosed bronchial asthma Subjects in the Age Group Range of 18 – 25 years Both male and female subjects Mild to moderate Airway obstruction using PEFR with pre and post test reversibility of at least 20% Mild to moderate Airway obstruction with Fev1 / Fvc Ratio.
- •60 to 70 percent Mild to Moderate Asthma as per GINA severity grading.
排除标准
- •Subjects below the age of 18 and above 25 Subjects with any Active respiratory infection Subjects with Restrictive Airway Disease like IPF Subjects with Active Tuberculosis Infection Subjects with COPD, ACOS, Cystic Fibrosis Subjects with Congenital and other acquired heart diseases Subjects with chest wall deformities – Pectus Excavatum and Arcuatum Pregnant Female subjects.
结局指标
主要结局
Inspiratory Capacity and Expiratory Flow
时间窗: baseline | 3 weeks | 6 weeks | 9 weeks | 12 weeks
Dyspnea Assessment
时间窗: baseline | 3 weeks | 6 weeks | 9 weeks | 12 weeks
次要结局
- Recurrence of Asthma Exacerbations(Quality of Life Assessment)
研究者
R Kaushik
Faculty of Physiotherapy, Dr. M.G.R. Educational and Research Institute