Impact of Yoga on Patients with Chronic Kidney Disease on peritoneal dialysis – an observational study (YOGII PD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
End-stage renal disease (ESRD) is an anomaly of kidney function indicated by low glomerular filtration rate (GFR) and elevated urinary albumin: creatinine ratio (ACR). ESRD is a non-communicable disease, which is contributed majorly by hypertension and diabetes. ESRD patients and often patients with terminal diseases tend to try complementary and alternative therapies like mind-body interventions (MBIs). MBIs are low cost, have low physical and emotional risk, and have more control over his/her treatment. Yoga and meditation are prominent MBIs. The Aim of this study is to evaluate the feasibility and patient’s compliance on using yoga therapy as an adjunct with standard treatment in ESRD patients to improve quality of life (QoL) in patients undergoing PD. enrolled patients will be given a special Yoga protocol along with the standard treatment care for their kidney disease, and no interference in their respective allopathy treatment will occur. The study duration will be of twelve months and yoga intervention for three months. QoL, Insomnia and Caregiver burden will be assessed before and after the Yoga Intervention and then the Data will be analysed with approriate statistical tools
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
- •Patients with ESRD on PD visiting AIIMS Raipur.
- •Adults >18 to 80 years of age.
- •Willing and able to comply with the study requirements.
- •Subjects who are physically able to perform Yoga practices.
- •Subjects who can be available for online/offline follow-ups.
- •Patients with no planned change in dialysis modality and with no planned renal transplant during the study period.
排除标准
- •Patients confined to bed with fractures, post-surgical period, Severe mental illness, disoriented, confusion Uncontrolled hypertension at screening visit Major surgery within 30 days of the initiation of the study.
- •Pregnant lactating women History of stroke or intracranial bleed Hemoglobin less than 8 mg per dl at the screening visit Active infection at the initiation of the study.
- •Presence of other clinically significant systemic disorders or diseases like respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease, or any other body system involvement Currently active clinically significant cardiovascular disease.
结局指标
主要结局
Quality of Life
时间窗: Day 1 (Baseline visit) | Day 90 (end of the study visit)
次要结局
- Improvement in sleep and reduction in Burden on care giver(Day 1 (Baseline visit))