| 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
|
|
|
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
|
|
|
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. |