| CTRI Number |
CTRI/2022/06/043509 [Registered on: 27/06/2022] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Yoga on Patients with Chronic Kidney Disease on peritoneal dialysis |
|
Scientific Title of Study
|
Impact of Yoga on Patients with Chronic Kidney Disease on peritoneal dialysis – an observational study (YOGII PD) |
| Trial Acronym |
YOGII PD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinay Rathore |
| Designation |
Assistant Professor Nephrology |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Nephrology, All India Institute of Medical Sciences, GE Road, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
vinayrathoredm@aiimsraipur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer (Yoga & Naturopathy) |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Yoga & Naturopathy, All India Institute of Medical Sciences, GE Road, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
dr.vikrampai@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer (Yoga & Naturopathy) |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Yoga & Naturopathy, All India Institute of Medical Sciences, GE Road, Tatibandh, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
dr.vikrampai@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences (AIIMS) Raipur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Raipur |
| Address |
All India Institute of Medical Sciences, Raipur
GE Road, Tatibandh, Raipur |
| Type of Sponsor |
Government medical college |
|
|
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 Vikram Pai |
All India Institute of Medical Sciences, Raipur |
Dept of Yoga & Naturopathy, first floor, AYUSH Building, AIIMS, Raipur, GE Road, Tatibandh
Raipur
CHHATTISGARH |
8076431586
dr.vikrampai@aiimsraipur.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, Raipur |
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 |
NIL |
NIL |
| Intervention |
Yoga Protocol |
35 minute Yoga protocol comprising Loosening exercises, 2 Yoga poses, 3 breathing practices and guided relaxation practice.
Duration of Intervention for each subject is 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ESRD on PD visiting AIIMS Raipur.
Adults >18 to 80 years of age.
Willing and able to comply with the study requirements.
Subjects who are physically able to perform Yoga practices.
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
|
|
| ExclusionCriteria |
| Details |
Patients confined to bed with fractures, post-surgical period, Severe mental illness, disoriented, confusion
Uncontrolled hypertension at screening visit
Major surgery within 30 days of the initiation of the study.
Pregnant lactating women
History of stroke or intracranial bleed
Hemoglobin less than 8 mg per dl at the screening visit
Active infection at the initiation of the study.
Presence of other clinically significant systemic disorders or diseases like respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease, or any other body system involvement
Currently active clinically significant cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
Day 1 (Baseline visit)
Day 90 (end of the study visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in sleep and reduction in Burden on care giver |
Day 1 (Baseline visit)
Day 90 (end of the study visit) |
|
|
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)
|
30/06/2022 |
| Date of Study Completion (India) |
06/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/11/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 undergoing PD. 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 allopathy 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
|