Impact of Yoga on Quality Of Life of End-Stage Renal Disease Patients on Maintenance Hemodialysis - A Mixed Methods Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- 1. Katz Index of Independence in Activities of Daily Living
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 Maintanence Hemodialysis. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
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 maintenance hemodialysis visiting AIIMS Raipur.
- •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.
- •Severe mental illness, disoriented, confused.
- •Uncontrolled hypertension at screening visit.
- •Pregnant/lactating women.
- •Hemoglobin less than 8 mg/dl at screening visit.
- •Presence of other clinically significant systemic disorders or diseases (respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) which, in the investigators opinion, could compromise the patient safety for performing yoga.
结局指标
主要结局
1. Katz Index of Independence in Activities of Daily Living
时间窗: Baseline visit on Day 1 and End of the study visit on Day 90
2. Kidney Disease Quality of Life Instrument–Short Form. (KDQOL-36)
时间窗: Baseline visit on Day 1 and End of the study visit on Day 90
3. In-depth interview with content analysis pre and post Intervention (Yoga)
时间窗: Baseline visit on Day 1 and End of the study visit on Day 90
次要结局
- 1. Insomnia severity index(2. The Participation Scale)