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CTRI Number  CTRI/2018/01/011382 [Registered on: 17/01/2018] Trial Registered Prospectively
Last Modified On: 16/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Yoga effect on cognitive performance in male and female 
Scientific Title of Study   Investigating differences in mindfulness and neurocognitive performance between male and female yoga and non-yoga practitioners: a case control study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepeshwar Singh 
Designation  Assistant Professor 
Affiliation  Swami Vivekananda Yoga University (S-VAYSA) 
Address  Department of Yoga and Life Sciences
19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar
Bangalore
KARNATAKA
560019
India 
Phone  9036367402  
Fax    
Email  deepeshwar.singh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Deepeshwar Singh 
Designation  Assistant Professor 
Affiliation  Swami Vivekananda Yoga University (S-VAYSA) 
Address  Department of Yoga and Life Sciences
19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar

KARNATAKA
560019
India 
Phone  9036367402  
Fax    
Email  deepeshwar.singh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kiran Menon 
Designation  MSc Scholar 
Affiliation  Swami Vivekananda Yoga University (S-VAYSA) 
Address  Department of Yoga and Life Sciences
19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar
Bangalore
KARNATAKA
560019
India 
Phone  9036367402  
Fax    
Email  kiran007menon@gmail.com  
 
Source of Monetary or Material Support  
Swami Vivekananda Yoga University, Department of Yoga and Cognitive Neuroscience, 19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar, Bengaluru 
 
Primary Sponsor  
Name  Swami Vivekananda Yoga University  
Address  Department of Yoga and Cognitive Neuroscience, 19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar, Bengaluru 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepeshwar Singh  Swami Vivekananda Yoga University  Division of Yoga and Life Sciences, Yoga and Cognitive Neuroscience, 19 Eknath Bhavna, Gavipuram Circle, K.G. Nagar, Bengaluru.
Bangalore
KARNATAKA 
9036367402

deepeshwar.singh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of S-VYASA University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Male and Female Participants 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  This group participants will not have any yoga experience. 
Intervention  Yoga Group  All participants in Yoga Group will have minimum 24 month experience 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Yoga Group (YG) participants will be consisted of students of graduate, postgraduate and yoga therapists with a minimum of two years’ experience and resident of the yoga center and routine yogic lifestyle.
2. Non-Yoga Group (NY) participants will be recruited from nearby medical college students and while selection they should be non-smokers or a non-alcoholic, vegetarian diet.
3. All participants will be screened to rule out possible cognitive deficiency using the Mini-Mental State Examination with a cut-off score 27. 
 
ExclusionCriteria 
Details  1. Any participant with the neurological or psychiatric problems.
2. Smoking, drugs etc.
3. Any medication which influences cognitive functions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Visual n-back task,
2. Color-Word Stroop Task, and
3. Running memory span,
 
Day 1 and Day 2 
 
Secondary Outcome  
Outcome  TimePoints 
1. Positive and Negative Affect Schedule (PANAS),
2.The Freiburg Mindful Inventory [FMI],
3. State-Trait Anxiety Inventory (STAI),
4. Positive states of mind (POSM), and
5. Perceived stress scale (PSS-10) 
Day 3 and Day 4 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Phase 1 
Date of First Enrollment (India)   25/01/2018 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Existing research on yoga intervention demonstrates a beneficial effect on general well-being and physical health among yoga practitioners of both genders. But these investigations are mainly focused on the short or long-term intervention of yoga. To date, however, the effectiveness of regular yoga practice in improving psychological well-being and neurocognitive performance of both gender has not been examined. The primary focus of this study was gender-based yoga practice effect on neurocognitive functions and secondary focus was on the difference with matched non-practitioners. Therefore, the present study intended to investigate gender differences in mindfulness and neurocognitive performance between male and female yoga practitioners and non-practitioners. We hypothesized that i) the female yoga practitioners would result in lowered state and trait anxiety and perceived stress than male yoga practitioners, ii) the male yoga practitioners would have higher neurocognitive performance but females would result in higher accuracy and iii) yoga practitioners would have higher mindfulness and neurocognitive performance than non-practitioners.

 
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