CTRI Number |
CTRI/2022/02/040099 [Registered on: 08/02/2022] Trial Registered Prospectively |
Last Modified On: |
09/02/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Yoga Therapy for dementia in elderly with vascular cause |
Scientific Title of Study
|
To evaluate the effects of Yoga on Cognitive function, activities of daily living, self-reported Depression, and Heart Rate Variability in subjects with Vascular Dementia |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Raghavendra Rao M |
Designation |
Director |
Affiliation |
Central Council for Research in Yoga & Naturopathy |
Address |
Department of Research, Division of Yoga, Room No 107, Central Council for Research in Yoga and Naturopathy CCRYN, Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi
New Delhi DELHI 110058 India |
Phone |
9916488864 |
Fax |
|
Email |
raghav.hcgrf@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vadiraj HS |
Designation |
Research Officer |
Affiliation |
Central Council for Research in Yoga & Naturopathy |
Address |
Department of Research, Division of Yoga, Room No 107, Central Council for Research in Yoga and Naturopathy CCRYN, Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi
New Delhi DELHI 110058 India |
Phone |
9350147313 |
Fax |
|
Email |
vadiraj77@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Garima |
Designation |
Senior Research Fellow |
Affiliation |
CCRYN OPD, Dr. Ram Manohar Lohia Hospital, New Delhi |
Address |
Room no. 35,36 Yoga & Naturopathy OPD, Department of Psychiatry, Dr. Ram Manohar Lohia Hospital, New Delhi
(Running under the aegis of CCRYN)
New Delhi DELHI 110001 India |
Phone |
9945558931 |
Fax |
|
Email |
garimamishrayoga@gmail.com |
|
Source of Monetary or Material Support
|
Central Council for Research in Yoga and Naturopathy Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi
|
|
Primary Sponsor
|
Name |
Central Council for Research in Yoga and Naturopathy Ministry of AYUSH |
Address |
61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi
|
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 Mina Chandra |
Room no. 4, Psychiatry OPD |
Centre of excellence in Mental Health, Department of Psychiatry, Atal Bihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Rd. Type III,New Delhi New Delhi DELHI |
9811831902
doctorminachandra@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, ABVIMS & Dr. RML Hospital, New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F015||Vascular dementia, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
Intervention |
Yoga Therapy |
Patients will be made to perform selected yogic practices including breathing exercises, meditation, and yoga postures for 60 minutes, thrice a week for 2 months (8 weeks) guided by a certified yoga instructor. The medium will primarily be online, and wherever required and possible, assisted with offline sessions. |
|
Inclusion Criteria
|
Age From |
55.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
1.Diagnosed case of Vascular Dementia as per DSM V.
2.Age above 55 – 75 years
3.Zubrods performance status 1-2 |
|
ExclusionCriteria |
Details |
1.Dementia due to any other etiology
2.History of recent /past Head Injury resulting in neurologic deficits
3.History of Neurosurgery-Craniotomy
4.History of Substance Dependence other than Nicotine
5.Those with prior h/o depression, a major psychiatric illness associated with cognitive illness
6.Those with brain metastases
7.Concurrent medical condition likely to influence survival
8.Uncontrolled diabetes, hypertension, and autoimmune disease
9.Neurological disorders such as any significant head injury, epilepsy, Parkinson’s disease, neurodegenerative disorders, etc.
10.Regular participation in an active behavioral intervention/yoga in the last six months
11.H/o recent brain infections or fever in the past two months (meningitis/encephalitis)
12.Those with anemia (Hemoglobin < 10gm %)
13.LVEF<40%
14.H/o recent atrial fibrillation |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Cognitive Functions |
Before and after 2 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Self-reported Depression |
Before and after 2 months |
Heart Rate Variability |
Before and after 2 months |
Activities of Daily living |
Before and after 2 months |
|
Target Sample Size
|
Total Sample Size="104" Sample Size from India="104"
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)
|
14/02/2022 |
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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Yoga-based interventions appear to significantly improve several cognitive domains in elderly such as immediate and delayed recall, verbal and visual memory, attention, working memory, verbal fluency, executive function, and processing speed. Yoga has emerged as an effective and feasible add on therapy in schizophrenia, with special benefits in improving social cognition and negative symptoms. Yoga was found to benefit individuals with depressive symptoms, including quality of life and cognition. Some of the consistent effects of yoga practice include stress reduction, emotion regulation, improved mood and well being. Though, the studies have shown the beneficial effect of Yoga in improving the cognitive functions, no study till date has been studied to understand the role of Yoga in Vascular Dementia. The study will evaluate the effect of yoga on cognitive functions, self reported Dementia, the activity of daily living, and heart rate variability in Vascular dementia patients who are undergoing conventional therapy. This study is a randomized controlled trial, where we will compare two groups, case group - yoga intervention integrated with conventional treatment and control group. There will be 52 participants in each group diagnosed with vascular dementia by the specialist. Assessments of variables will be done at baseline and completion of 8 weeks. The intervention will be given for 8 weeks to all the participants in the case group. |