跳至主要内容
临床试验/CTRI/2025/01/079269
CTRI/2025/01/079269招募中不适用

Impact of 6-week Integrated Yoga on Cardiac-Autonomic Functions and Health-Related Quality of Life among Patients with Chronic Kidney Disease Undergoing Haemodialysis- A Randomized Controlled Trial

Shriya S1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
88
试验地点
1
主要终点
1. Cardiac-autonomic functions

研究概览

简要总结

Chronic kidney disease (CKD) is a serious global health issue, affecting 10.4% of men and 11.8% of women worldwide, with a 9.1% prevalence overall in 2017. Asia, particularly China and India, bears a significant CKD burden, with these two countries accounting for 69.1% of CKD cases in the region. In India, CKD affects 17.2% of the population, with incidence rates continuing to rise. Projections indicate that CKD may become the fifth leading cause of death globally by 2040.

CKD is marked by a gradual decline in kidney function, leading to complications and potentially end-stage kidney disease (ESKD). Its progression is influenced by molecular mechanisms such as nephron reduction, podocyte damage, and activation of EGFR signaling pathways. The disease imposes heavy economic costs, especially in developing nations where treatment options are limited. Major CKD risk factors include obesity, hypertension, diabetes, age, and high cholesterol, with hypertension and diabetes responsible for approximately 75% of cases. Additionally, CKD is linked to an elevated risk of cardiovascular disease, contributing to increased morbidity and mortality.

CKD symptoms span multiple body systems, affecting mental, neurological, cardiopulmonary, and physical health. While modern treatments aim to slow CKD progression, they largely focus on symptom management, leaving patients with significant physical, psychological, and emotional challenges. These symptoms may include depression, anxiety, cognitive impairment, fatigue, pain, sleep issues, appetite loss, muscle soreness, and compromised autonomy.

Yoga, incorporating physical postures, breathing techniques, and meditation, has been shown to improve various health outcomes in CKD patients, including reduced pain, fatigue, improved sleep, and better biochemical markers in haemodialysis patients. Practices like Yoga-Nidra, laughter yoga, and clapping exercises have demonstrated reductions in depression, anxiety, stress, blood pressure, and serum creatinine levels. Research suggests a six-month yoga program can enhance renal function and quality of life, reduce oxidative stress, and offer psychological relief. Yoga is generally safe for haemodialysis patients and may effectively complement CKD management by addressing both physical and psychological health needs, potentially leading to better health outcomes and patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants with CKD undergoing hemodialysis
  • Those who are willing to participate.

排除标准

  • Those with Hb levels less than 8 g/L
  • Those with serum calcium levels less than 9 mmol/L
  • Those with a history of substance abuse; those diagnosed and on therapy for psychotic illnesses
  • Other chronic conditions such as recent/history of stroke, post coronary artery bypass grafting, morbid obesity, uncontrolled diabetes, and uncontrolled hypertension.
  • Single working kidney, congenital renal malformations, previous carcinoma, or any previous renal pathology or surgery.
  • Recent fractures of the lower limb/ recent lower limb surgery, severe knee joint pain/ osteoarthritis will be excluded from the study.
  • Exposure to yoga practice in the past three months.

结局指标

主要结局

1. Cardiac-autonomic functions

时间窗: Data collection will be done twice- at baseline and end of the 6th week. Follow up will be done at the end of 12th week respectively.

2. Health-related quality of life

时间窗: Data collection will be done twice- at baseline and end of the 6th week. Follow up will be done at the end of 12th week respectively.

次要结局

  • 1. Biochemical parameters.(2. Anthropometric variables.)

研究者

发起方
Shriya S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shriya S

Sri Devaraj Urs Academy of Higher Education and Research

研究点 (1)

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