Yoga as a complementary therapy in Chronic Kidney Disease: Impact on clinical, biochemical, molecular and quality of life parameters in CKD stage 3 and 4
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Reduction in proteinuria, stable or increased glomerular filtration rate, improvement in renal function tests and quality of life.
研究概览
简要总结
Chronic kidney disease (CKD) is a global health burden defined as irreversible kidney injury and has repercussions for other organs, leading to many extrarenal complications. Currently, CKD treatment focuses on its complications, hypertension, diabetes. Underlying mechanism driving CKD like oxidative stress, inflammation remain unaddressed. Yoga targets these factors and control blood pressure, diabetes which is crucial to slowdown CKD progression. Yoga modulates gene expression epigenetically, improves fitness, mental health thereby improving QOL. Effects of lifestyle intervention like yoga which target physical, psychological & molecular aspects of body remain explored in CKD. Our study aims to find effect of yoga on CKD progression by assessing clinical, molecular parameters, urinary exosomal miRNA.
Objectives:
1. To determine effect of yoga intervention on CKD progression by assessing clinical parameters (eGFR, proteinuria, RFT’s, BCM) along with QOL in CKD patients.
2. To investigate effect of yoga on markers of inflammation, oxidative stress, CKD metabolic bone disease, kidney injury and adipokines
3. To investigate effect of yoga on expression and methylation pattern of genes involved in CKD and impact on miRNA profile in urinary exosomes
4. To investigate effect of yoga on dysregulated lipids and metabolites in blood by using advanced omics techniques (LC-MS)
Methods:
Blood samples for biochemistry, ELISA, PCR, LC-MS. Urine samples for proteinuria estimation and exosome isolation.
Expected Outcome:
Improvement in clinical parameters, biomarkers and normalization of dysregulated genes, miRNA expression along with enhanced QOL and identification of novel
dysregulated lipids and metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •CKD stage 3 & 4 patients, Mentally and physically fit up to a level to understand and perform yogic asanas, Not enrolled in regular yoga practice.
排除标准
- •Exclusion criteria will be HIV, HCV HBsAg +ve patients, individuals with severe cardiovascular conditions active infection, respiratory conditions COPD, neurological disorder and cancer.
结局指标
主要结局
Reduction in proteinuria, stable or increased glomerular filtration rate, improvement in renal function tests and quality of life.
时间窗: After 3 months of yoga intervention.
次要结局
- Reduction in markers of inflammation and oxidative stress.(Markers of CKD metabolic bone disease and kidney injury and adipokines will come toward normal.)
- Expression and methylation pattern of genes involved in CKD will come toward normal.(Profibrotic miRNA in urinary exosomes should decrease post yoga.)
- Dysregulated lipids and metabolites in blood of CKD patients will be identified by advanced omics techniques. (LC-MS)(After 3 months of yoga intervention.)