跳至主要内容
临床试验/CTRI/2023/04/051685
CTRI/2023/04/051685已完成不适用

Impact of Yoga on Patients with Chronic Kidney Disease without dialysis - A Mixed Methods Pilot Study

Central Council for Research in Yoga and Naturopathy1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
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 not undergoing any dialysis. 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 standard 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
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 Chronic kidney disease visiting AIIMS Raipur.
  • Willing and able to comply with the study requirements.
  • 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)

研究者

发起方
Central Council for Research in Yoga and Naturopathy
申办方类型
Government funding agency

研究点 (1)

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