| CTRI Number |
CTRI/2023/04/051685 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Yoga in Patients with Chronic Kidney Disease not undergoing dialysis |
|
Scientific Title of Study
|
Impact of Yoga on Patients with Chronic Kidney Disease without dialysis - A Mixed Methods Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer Yoga and Naturopathy |
| Affiliation |
All India Institute of Medical Sciences Raipur |
| Address |
Department of Yoga and Naturopathy AYUSH Building First floor All India Institute of Medical Sciences Raipur G E Road Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8076431586 |
| Fax |
|
| Email |
dr.vikrampai@aiimsraipur.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer Yoga and Naturopathy |
| Affiliation |
All India Institute of Medical Sciences Raipur |
| Address |
Department of Yoga and Naturopathy AYUSH Building First floor All India Institute of Medical Sciences Raipur G E Road Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8076431586 |
| Fax |
|
| Email |
dr.vikrampai@aiimsraipur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Pai |
| Designation |
Medical Officer Yoga and Naturopathy |
| Affiliation |
All India Institute of Medical Sciences Raipur |
| Address |
Department of Yoga and Naturopathy AYUSH Building First floor All India Institute of Medical Sciences Raipur G E Road Tatibandh Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8076431586 |
| Fax |
|
| Email |
dr.vikrampai@aiimsraipur.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raipur, G.E. Road, Tatibandh, Raipur, C.G 492099 |
| Central Council for Research in Yoga and Naturopathy 61 to 65 Institutional Area Janakpuri New Delhi 110058 Ph 011 28520430 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Yoga and Naturopathy |
| Address |
61-65, Institutional Area, Janakpuri, New Delhi, 110058 Ph 011 28520430 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
Department of Yoga and Naturopathy, AYUSH Building, First Floor, All India Institute of Medical Sciences, Raipur, G.E. Road, Tatibandh, Raipur
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: N183||Chronic kidney disease, stage 3 (moderate), (2) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), (3) ICD-10 Condition: N185||Chronic kidney disease, stage 5, (4) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
40 Min Yoga Protocol atleast 3 days a week |
Yoga protocol comprising loosening exercises, Yoga poses, Breathing practices and Guided relaxation technique. Duration of Intervention will be 3 months for each patient |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Chronic kidney disease visiting AIIMS Raipur. 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. Severe mental illness, disoriented, confused. Uncontrolled hypertension at screening visit. Pregnant/lactating women. Hemoglobin less than 8 mg/dl at screening visit. Presence of other clinically significant systemic disorders or diseases (respiratory, gastrointestinal, endocrine, immunological, dermatological, neurological, psychiatric disease or any other body system involvement) which, in the investigators opinion, could compromise the patient safety for performing yoga |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Katz Index of Independence in Activities of Daily Living
2. Kidney Disease Quality of Life Instrument–Short Form (KDQOL-36)
3. In-depth interview with content analysis pre and post Intervention (Yoga) |
Baseline visit on Day 1 and End of the study visit on Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Insomnia severity index
2. The Participation Scale |
Baseline visit on Day 1 and End of the study visit on Day 90 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2023 |
| Date of Study Completion (India) |
17/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/10/2024 |
|
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 not undergoing any dialysis. 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 standard 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 |