Effect of modified Yoga program on chronic kidney disease (CKD) Patients undergoing Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Estimated Glomerular Filtration Rate (eGFR)
研究概览
简要总结
Background: CKD patients undergoing dialysis suffer not only physically, they also suffer mentally and emotionally. Evidence base studies have proved that Yoga has a positive impact on the Physical and Psychological domains.
The hypothesis of the study: Modified Yoga program intervention on CKD patients undergoing Dialysis will be significant in
-
eGFR, Renal function test (RFT), Blood Biochemistry test, Nephrotic - Ultrasound, Blood Pressure (BP), Heart Rate (HR), and Medications score
-
Pain, Depression, Anxiety, Fatigue, Symptom, Sleep Quality and Quality of life compared to Control group.
The aim of the study:
To Study the Effect of modified Yoga program on subjective and objective parameters of CKD patients undergoing Hemodialysis.
Design of the Study:
The study is a randomized wait-list controlled study, the recruited participants will be divided into two groups
-
Intervention group: They will be receiving the modified yoga program as an intervention in addition to the conventional therapies (medications and hemodialysis)
-
Waitlist control group: The participants will continue to receive the conventional therapies during the intervention period. They will be offered the same yoga intervention following the follow-up period.
Intervention:
The intervention group will receive modified Yoga practices for a period of 3 months and follow up to 6 months
1. Simple Yogic exercise
-
Yogic breathing practice (Pranayama)
-
Yogic guided Meditation (MSRT)
Assessments:
Assessments will be done at Baseline, 1st month, 3rd month, and 6th month
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •CKD patients undergoing dialysis
- •CKD patients who are willing to be part of the study and sign the consent form.
- •CKD patients with age (
- •years.
- •CKD patients without cardiovascular complications.
- •ESRD with CKD stage 5 patients.
排除标准
- •CKD patients with cardiovascular complications.
- •Non-ESRD with CKD stage 1 to 4 patients.
结局指标
主要结局
Estimated Glomerular Filtration Rate (eGFR)
时间窗: Baseline | 1st month | 3rd month | 6th month
次要结局
- 1.Creatinine(2.Serum Electrolytes with Potassium)
- 1.Pain: Visual analog scales (VAS)(2.Depression: Hamilton Depression Rating Scale (HAM-D))