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CTRI Number  CTRI/2019/02/017678 [Registered on: 14/02/2019] Trial Registered Prospectively
Last Modified On: 14/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Other (Specify) [YOGA]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Yoga on Cognition in College Level Athletes 
Scientific Title of Study   Effect of Yoga on Reaction Time, Working Memory and Attention in College Level Athletes. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Nanaware 
Designation  PG Student 
Affiliation  Centre for Sports Science, Medicine and Research, MAHE 
Address  Centre for Sports Science, Medicine and Research, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7506827511  
Fax    
Email  aashieshn@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mayuri Joshi 
Designation  Assistant Professor 
Affiliation  Centre for Sports Science, Medicine and Research, MAHE 
Address  Centre for Sports Science, Medicine and Research, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8989176416  
Fax    
Email  mayuri.joshi@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ashish Nanaware 
Designation  PG Student 
Affiliation  Centre for Sports Science, Medicine and Research, MAHE 
Address  Centre for Sports Science, Medicine and Research, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7506827511  
Fax    
Email  aashieshn@gmail.com  
 
Source of Monetary or Material Support  
Centre for Sports Science, Medicine and Research, Manipal Academy of Higher Education, Manipal-576104 
 
Primary Sponsor  
Name  Ashish Nanaware 
Address  Centre for Sports Science, Medicine and Research, Manipal Academy of Higher Education, Manipal-576104 
Type of Sponsor  Other [Centre for Sports Science, Medicine and Research, MAHE] 
 
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 
Ashish Nanaware  Centre for Sports Science, Medicine and Research, MARENA  Centre for Sports Science, Medicine and Research, Manipal Academy of Higher Education, Manipal-576104
Udupi
KARNATAKA 
7506827511

aashieshn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Reaction Time, Working Memory and Attention 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Education regarding yoga  Education regarding yogic postures 
Intervention  supervised yoga  supervised yoga for 4 weeks thrice/week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  -College/institutional level athletes (both land and water based).
-Participants who can understand English language.
-Not practicing yoga for at least past 6 months 
 
ExclusionCriteria 
Details  -History of any musculoskeletal injury that limits participation in physical activity.
-History of any mental illness or psychological disorder.
-Taking psychoactive drugs.
-Substance abusers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Memory (n-back)  Immediate and post intervention (after four weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
Reaction time (flanker)  Immediate and post intervention (after four weeks) 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   15/02/2019 
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="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Journal of Clinical Psychology. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Quick decision making or a quick response in sports requires a well-trained mind. The status of mind, how it responds before a game and during the game, is a major determining outcome factor.
   In order to train for cognitive performance, there are several computer-based training programs available. These programs are usually expensive and athletes, especially at college level, may not be able to afford these programs.
   A very convenient and feasible mode for cognitive training is yoga. Yoga is an ancient and traditional exercise method known to improve health of individuals. Various meditation techniques, breathing techniques and postures are described in ancient yogic scriptures.
   Significance of cognitive functions among athletes is not studied thoroughly.  With this study we aim to find out whether the practice of yoga; namely yogic postures, Surya-namaskar and pranayama help athletes to improve their reaction time, working memory and attention, which as a result will help enhance their performance in the game. The cognitive function will be assessed based on the changes in reaction time of athletes pre and post intervention.
   56 subjects will be recruited for the study. They will be randomly selected, provided they meet the inclusion and exclusion criteria.

   Flanker Test - Eriksen & Eriksen (1974) and N-back Task - Jaeggi et al (2010) will be used to determine the outcomes of the study. 

   Participants in the Yoga group will be given a 30-minute program comprising of 3 rounds of Surya-namaskar (sun salutation), 5 minutes of Shavasana (supine resting position), 5 minutes of Swastikasana, 13 minutes of Pranayama (which includes Anuloma viloma pranayama, Suryabedhana pranayama, Bhramari pranayama) and 5 minutes of So-ham meditation (17). Participants will be encouraged to follow this program thrice a week for 4 weeks without modifying any other daily routine. 

   The sessions will be conducted on alternate days, early in the morning, preferably on empty stomach  Control group participants will follow their normal daily routine without any modification; they will be advised against doing Yoga until the end of study period.

   Data will be entered in a master chart and checked for normality using Shapiro Wilk test. Depending on the normality, parametric (paired and independent t test) or non-parametric (Whitney U test and Wilcoxon sign rank test) test will be used for analysis. Level of significance will be set at 0.05.
   Within and between groups comparison results will be used to comment about the effectiveness of yoga program on cognitive functioning in college level athletes.


 
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