The Effect of Adjuvant Yoga Therapy on Inflammatory Biomarkers in Children with Bronchial Asthma - A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- TO EVALUATE THE EFFICACY OF ADJUVANT YOGIC INTERVENTION ON CHANGES IN ASTHMA-SPECIFIC INFLAMMATORY CYTOKINES- IL-4, IL-5, AND IL-13 AMONG CBA PATIENTS IN COMPARISON TO THE CONTROL GROUP OVER 3 MONTHS
研究概览
简要总结
Asthma is a prevalent non-communicable disease characterized by chronic airway inflammation and variable airflow obstruction. The global prevalence of asthma in children and adolescents is 9.1% and 11% respectively. The common symptoms of childhood bronchial asthma are breathing difficulty, chest tightness, and frequent coughing, which affects their quality of life, academic performance, and restricted activities. such as participation in sports, cycling swimming etc. Despite availability of pharmacological treatments such as long-acting beta 2 agonists and short-acting beta 2 agonists, which are managing symptoms to a great extent, but still they have multiple side effects such as fever, nausea therefore as an add on intervention is required to minimize the adverse effects and efficient asthma management. Yoga has evolved as an evidence based holistic approach for mind body medicine and literatures suggest that yoga as an add on intervention has a significant impact on children with bronchial asthma, improving quality of life and lung function etc. This study aims to evaluate the effect of adjuvant yoga therapy on inflammatory biomarkers (IL-4, IL-5, IL-13) in children with bronchial asthma. Our secondary objectives are comparing asthma related crisis events, functional exercise capacity, pulmonary functions (PEFR, FEV, FVC), quality of life and sleep quality between both intervention and control groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 7.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •PATIENTS DIAGNOSED WITH MILD AND MODERATE ASTHMA FOLLOWING GLOBAL INITIATIVE FOR ASTHMA GUIDELINES.
- •PATIENTS AGED BETWEEN 07-17 YEARS.
- •PATIENTS HAVING HISTORY OF ASTHMA AT LEAST FOR 06 MONTHS.
- •WHOSE PARENTS PROVIDE WRITTEN CONSENT AND ASSENT FROM CHILDREN.
排除标准
- •ONE WHO IS ALREADY ENGAGED IN SIMILAR THERAPIES LIKE ALREADY DOING YOGA PRACTICES.
- •CHILDREN TAKING ORAL STEROIDS, ANTI-ANXIETY OR ANTI-DEPRESSANT MEDICINES.
- •CHILDREN WITH SEVERE CARDIOVASCULAR & NEUROMUSCULAR DISEASE, TUBERCULOSIS, OR ANY OTHER CONCOMITANT PULMONARY DISEASE.
- •PATIENTS WITH A HISTORY OF ANY MAJOR SURGERY.
- •CHILDREN WITH ANY SEVERE PSYCHOLOGICAL DISEASE.
- •CHILDREN WITH UNCONTROLLED EPILEPSY AND MOVEMENT DISORDERS (TREMORS PARKINSON’S DISEASE ETC.).
结局指标
主要结局
TO EVALUATE THE EFFICACY OF ADJUVANT YOGIC INTERVENTION ON CHANGES IN ASTHMA-SPECIFIC INFLAMMATORY CYTOKINES- IL-4, IL-5, AND IL-13 AMONG CBA PATIENTS IN COMPARISON TO THE CONTROL GROUP OVER 3 MONTHS
时间窗: AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK
次要结局
- TO COMPARE ASTHMA-RELATED CRISIS EVENTS INCLUDING ACUTE EXACERBATIONS, EMERGENCY CARE VISITS, HOSPITALIZATION, NEED OF NEBULIZATION, AND FREQUENCY USE OF BRONCHODILATORS.(AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK)
- TO COMPARE THE EFFECT OF YOGA INTERVENTION ON IMPROVEMENT IN FUNCTIONAL EXERCISE CAPACITY(AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK)
- TO EVALUATE THE EFFECT OF ADJUVANT YOGA THERAPY ON PULMONARY FUNCTIONS AMONG CHILDREN WITH BRONCHIAL ASTHMA(AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK)
- TO EVALUATE THE ASTHMA-RELATED QUALITY OF LIFE OF CHILDREN WITH BRONCHIAL ASTHMA(AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK)
- TO COMPARE THE CHANGES IN SLEEP QUALITY USING THE PAEDIATRIC SLEEP QUESTIONNAIRE (PSQ)(AT BASELINE AND FINAL ASSESSMENT END OF THE 12TH WEEK)
研究者
NEMICHAND VERMA
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH