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CTRI Number  CTRI/2025/01/079269 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of 6-week Integrated Yoga on HRV and Quality of Life in CKD Patients Undergoing Hemodialysis  
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shriya S 
Designation  Research Scholar in the Department of Integrative Medicine 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research

Kolar
KARNATAKA
563103
India 
Phone  8277624069  
Fax    
Email  shriya.svk0@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prabhakar K 
Designation  Dean of Faculty of Medicine and Principal 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Department of Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar

Kolar
KARNATAKA
563103
India 
Phone  9448048308  
Fax    
Email  drprabhakark@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Prabhakar K 
Designation  Dean of Faculty of Medicine and Principal 
Affiliation  Sri Devaraj Urs Academy of Higher Education and Research 
Address  Department of Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar

Kolar
KARNATAKA
563103
India 
Phone  9448048308  
Fax    
Email  drprabhakark@yahoo.in  
 
Source of Monetary or Material Support  
Sri Devaraj Urs Academy of Higher Education and Research, Tamaka Kolar Karnataka- 563103 India 
 
Primary Sponsor  
Name  Shriya S 
Address  Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar Karnataka India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashween Bilagi  RL Jalappa Hospital and Research Center  Department of Integrative Medicine Room No. 414, 4th floor, Yoga Therapy Hall, IPD ward RL Jalappa Hospital and Research Center Tamaka 563103
Kolar
KARNATAKA 
9886666636

ayushashwin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard care  Patients will undergo standard care under the supervision of a nephrologist. 
Intervention  Yoga therapy + Standard care  Integrated yoga therapy will be given to the intervention group; each session will last for 1 hour. The yoga intervention group will attend yoga sessions five times a week for 6 weeks. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Participants with CKD undergoing hemodialysis
2. Those who are willing to participate
 
 
ExclusionCriteria 
Details  1. Those with Hb levels less than 8 g/L
2. Those with serum calcium levels less than 9 mmol/L
3. Those with a history of substance abuse; those diagnosed and on therapy for psychotic illnesses
4. Other chronic conditions such as recent/history of stroke, post coronary artery bypass grafting, morbid obesity, uncontrolled diabetes, and uncontrolled hypertension.
5. Single working kidney, congenital renal malformations, previous carcinoma, or any previous renal pathology or surgery.
6. Recent fractures of the lower limb/ recent lower limb surgery, severe knee joint pain/ osteoarthritis will be excluded from the study.
7. Exposure to yoga practice in the past three months. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Cardiac-autonomic functions
2. Health-related quality of life 
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. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Biochemical parameters.
2. Anthropometric variables.
3. Other general parameters 
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. 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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