| CTRI Number |
CTRI/2024/08/072835 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing a standard yoga module for kidney failure patients on dialysis |
|
Scientific Title of Study
|
Development Validation and Pilot Testing of a standard Yoga Module for Chronic Kidney Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashween Bilagi |
| Designation |
Assistant Professor |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar
Kolar KARNATAKA 563103 India |
| Phone |
9886666636 |
| Fax |
|
| Email |
ayushashwin@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashween Bilagi |
| Designation |
Assistant Professor |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar
Kolar KARNATAKA 563103 India |
| Phone |
9886666636 |
| Fax |
|
| Email |
ayushashwin@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashween Bilagi |
| Designation |
Assistant Professor |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research |
| Address |
Department of Integrative Medicine Sri Devaraj Urs Academy of Higher Education and Research Tamaka Kolar
Kolar KARNATAKA 563103 India |
| Phone |
9886666636 |
| Fax |
|
| Email |
ayushashwin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research
Tamaka, Kolar- 563103
Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Ashween Bilagi |
| Address |
Department of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research |
| 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 Shobhana Nayak Rao |
RL Jalappa Hospital and Research Center |
Room no. 531
Department of Nephrology
Tamaka Kolar Kolar KARNATAKA |
9945982509
shobhana.nayak.rao@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 |
| Intervention |
Integrated Yoga + Standard care |
A validated structured yoga module will be given to the intervention group; each session will last for 1 hour. The intervention will be given 3 times a week for 4 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals diagnosed with CKD and undergoing dialysis.
2. Those who provide informed consent. |
|
| ExclusionCriteria |
| Details |
1. Individuals with a history of substance abuse, psychotic illnesses and those on therapy for psychotic illness.
2. Other chronic conditions: Recent stroke, Post coronary artery bypass grafting (CABG), morbid obesity, uncontrolled diabetes and hypertension.
3. Recent fractures of the lower limb/ recent lower limb surgery, severe knee joint pain or osteoarthritis will be excluded from the study.
4. Exposure to yoga in the past 3 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Perceived stress levels
Quality of sleep |
Data collection will be done initially at baseline. The intervention will be given for 4 weeks. Post-data will be collected after 4th week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Experience and acceptance of yoga.
Other biochemical parameters. |
Data collection will be done initially at baseline. The intervention will be given for 4 weeks. Post-data will be collected after 4th week. |
|
|
Target Sample Size
|
Total Sample Size="10" Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2024 |
| Date of Study Completion (India) |
30/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 prevalent and debilitating condition affecting millions worldwide. As the prevalence of CKD increases, there is a growing need for complementary therapies to complement traditional medical interventions. Yoga has been recognized as a holistic approach to enhancing physical, mental, and emotional well-being. Studies have shown that yoga interventions can improve various parameters related to CKD, such as blood pressure, oxidative stress, inflammation, and psychological stress. Yoga practices can also improve health-related quality of life, sleep disturbances, and fatigue in cancer patients. Additionally, yoga practices can reduce inflammatory markers and improve kidney function, lipid profiles, and overall quality of life in CKD patients. This research proposal aims to develop and validate a specialized yoga module specifically for CKD patients, ensuring consistency in the delivery of yoga interventions across different healthcare settings and research studies. The safety and feasibility of yoga practices for CKD patients is a critical gap in current knowledge. There is a lack of standardized yoga protocols tailored specifically for CKD patients, which hinders the evidence-based implementation of yoga as a therapeutic intervention. A patient-centred approach is needed in the development and validation of yoga protocols. The current literature focuses on short-term outcome of a sustained yoga practice on disease progression and quality of life.
|