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CTRI Number  CTRI/2020/02/023664 [Registered on: 28/02/2020] Trial Registered Prospectively
Last Modified On: 26/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Yoga]  
Study Design  Single Arm Study 
Public Title of Study   Effect of Yoga in Body Functions in Swimmers 
Scientific Title of Study   The Effect of Yoga Practices on Pulmonary Function, Cardiovascular and Autonomic variables, Body Composition, Hydration Status and Cognitive Function in Healthy Young Swimmers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha Singh 
Designation  PG Student 
Affiliation  Center for Integrative Medicine and Research 
Address  PG Student Division of Yoga Center for Integrative Medicine and Research MAHE Manipal
MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  7217657909  
Fax    
Email  msbauddh200@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Annapoorna K 
Designation  Head of Department 
Affiliation  Center for Integrative Medicine and Research 
Address  Division of Yoga Center for Integrative Medicine and Research MAHE Manipal
MAHE Manipal
Udupi
KARNATAKA
576104
India 
Phone  9845526727  
Fax    
Email  annapoorna.k@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Manisha Singh 
Designation  PG Student 
Affiliation  Center for Integrative Medicine and Research 
Address  Division of Yoga Center for Integrative Medicine and Research MAHE Manipal
MAHE Manipal

KARNATAKA
576104
India 
Phone  7217657909  
Fax    
Email  msbauddh200@gmail.com  
 
Source of Monetary or Material Support  
Institutional Funds for Post Graduates, Center for Integrative Medicine and Research, Manipal Academy for Higher Education 
 
Primary Sponsor  
Name  Center for Integrative Medicine and Research  
Address  Manipal Academy of Higher Education Manipal Karnataka 576104 
Type of Sponsor  Research institution and hospital 
 
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 
Manisha Singh  Division of Yoga  Division of Yoga, 1st floor, Dormitory Building, Kasturba Hospital, Manipal
Udupi
KARNATAKA 
7217657909

msbauddh200@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  No Health Issues 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Yoga  There will be 5 Yoga sessions per week for 4 weeks. Each Yoga Session is for 45mins: Asana (25 mins): Each posture is held for 5 regular breaths. 1. Swastikasana 2. Vajrasana 3. Suptavajrasana 4. Tadasana 1 5. Trikonasana 6. Parshvakonasana 7. Paschimottanasana 8. Purvottanasana 9. Marichasana 1 10. Marichasana 3 11. Bhujangasana 12. Shalabhasana 13. Dhanurasana Pranayama (10 mins): 10 rounds of each breathing technique are practiced. 1. Anulomaviloma Pranayama 2. SuryabhedanaPranayama 3. Bhramari Pranayama Relaxation (10 mins) 1. Makarasana 2. Shavasana1 3. Shavasana 0 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Swim for 30 minutes at least 3 times per week 
 
ExclusionCriteria 
Details  Individuals regularly practicing Yoga.
Any known medical condition. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pre and Post test values of Vital Capacity, Forced Expiratory Volume, Breath Holding Time, Heart rate response to during deep breathing: Sinus arrhythmia, Blood pressure response to Isometric handgrip, Heart rate and BP response to standing Ortho static Test, BMI, Body fat percentage, Body fat mass, Fat free mass, Total body water, Letter Cancellation Tasks score, Digit cancellation tasks score, The Trail making test score, Visual word memory test score, Object memory test score  At baseline, At 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   02/03/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Protocol

1. Title of the Project:
The Effect of Yoga Practices on Pulmonary Function, Cardiovascular and Autonomic variables, Body Composition, Hydration Status and Cognitive Function in Healthy Young Swimmers.

2. Type of Study: Basic Sciences

3. Aims & Objectives (hypotheses if applicable):
Aim: To assess the effects of yoga practices on pulmonary function, cardiovascular and autonomic variables, body composition, hydration status and cognitive function in healthy young swimmers.
Objectives:
● To assess pulmonary function, cardiovascular and autonomic variables, body composition, hydration status and cognitive function in healthy young swimmers.
● To compare the effects post- yoga intervention in healthy young swimmers.

4. Justification for study (whether of national significance with rationale):
A regular yoga practice has been associated with multiple positive aspects of physical, physiological and psychological outcomes. Significant changes in pulmonary function, cardiovascular and autonomic variables, body composition and cognitive function can be applied to improve attributes commonly linked to athletic performance, stress reduction, disease prevention, efficiency, longevity and improvement of physical and mental health of college students.

5. Departments involved:
● Division of Yoga, CIMR, Manipal
● Department of Physiology, Kasturba Medical College, Manipal

6. Study period: October 2019 to March 2020

7. Sample size: 52 (n=52), Convenience sampling
Sample size is calculated using R software (PWR Package) with a small effect size of 0.4, significance level 0.05 and 80% power

8. Materials and methods:
1) Participant information sheet
2) Informed consent form
3) Data Collection Form
4) Powerlab 8/35 analyzed by Labchart 8 Pro software to measure Heart rate, Blood pressure, ECG and Autonomic function
5) Computerized spirometry - Easy on PC, version VO3b, using airflow transducer to measure Lung function
6) Stethography to measure Breath Holding Capacity
7) Body stat - 1500 model for assessing the BMI, fat%, fat mass, fat free mass (FFM) and total body water (TBW), using surface electrodes.
8) Letter Cancellation Tasks (LCT) and Digit cancellation tasks for the assessment of visuospatial function and attention
9) Trail making test (TMT) for visual attention and task switching
10) Visual word memory test and Object memory test to assess short-term memory and cognitive performance

a) Inclusion and exclusion criteria:
Inclusion Criteria:
● Students between the age of 18 and 25 years, of both genders
● Swim for 30 minutes at least 3 times per week.
● Given written informed consent to participate in the study.
Exclusion Criteria:
● Individuals regularly practicing Yoga.
● Any known medical condition.
b) Biological materials required (type - blood, tissue etc and quantity): None
c) Statistical methods: Paired t-test

9. Detailed description of procedure / processes :
• Permission is obtained from the following authorities to sanction approval for the project:
-Head of Department, Division of Yoga
-Departmental Research Committee
-Institutional Research Committee
• Required documents are submitted to IEC for approval.
• Volunteers are approached and selected on the basis of convenience sampling.
• Selected participants are oriented about the purpose of the study and confidentiality of data.
• Participant information sheet and Informed consent form are given to the participant for
perusal and signing.
• Pre-test for pulmonary function, cardiovascular and autonomic variables, body composition,
and cognitive function will be conducted.
• Participants will undergo supervised Yoga intervention for 45 minutes per day, five days per
week.
Yoga Intervention:
a) Asana: Each posture is held for 5 regular breaths.
1. Swastikasana
2. Vajrasana
3. Suptavajrasana
4. Tadasana 1
5. Trikonasana
6. Parshvakonasana
7. Paschimottanasana 25 mins
8. Purvottanasana
9. Marichasana 1
10. Marichasana 3
11. Bhujangasana
12. Shalabhasana
13. Dhanurasana
b) Pranayama: 10 rounds of each breathing technique are practiced.
1. Anulomaviloma Pranayama
2. SuryabhedanaPranayama 10mins
3. Bhramari Pranayama
c) Relaxation
1. Makarasana
2. Shavasana1 10 mins
3. Shavasana 0
• After four weeks, post-test for pulmonary function, cardiovascular and autonomic variables, body composition, hydration status and cognitive function will be conducted.
• Collected data will be statistically analyzed using Paired t test and discussed.

10. Outcome measures: Pre- and Post- test values of:
● Vital Capacity
● Forced Expiratory Volume
● Breath Holding Time
● Heart rate response to during deep breathing: Sinus arrhythmia
● Blood pressure response to Isometric hand-grip (IHG)
● Heart rate and BP response to standing - Ortho static Test (OST)
● BMI
● Body fat percentage
● Body fat mass
● Fat free mass (FFM)
● Total body water (TBW)
● Letter Cancellation Tasks score
● Digit cancellation tasks score
● The Trail making test score
● Visual word memory test score
● Object memory test score

11. Potential risks and benefits:
This project poses minor increase over minimal risk to the participants. The participants will have to come twice to the Department of Physiology which may be inconvenient. Yoga intervention may have direct benefit to the participant by improving physical and psychological well-being and to the society for a better understanding of the effects of Yoga.

12. Ethical considerations and methods to address issues:
IEC clearance, Informed consent from participants.
Use of indirect identifier to ensure confidentiality.

13. Budget (give details) and proposed funding source:
10,000, Institutional funds for PG Thesis

14. Review of literature (within 1000 words) :
Yoga is a science, which deals with the body and mind; control of body and mind
(Digambarji, 1975). Yoga for swimmers : a new approach to improve balance, alignment & breathing. Yoga practices are recognized as a major part of the training regimen of
swimmers. This yoga training offers lots of benefits for swimmers, which extremely helps in
boosting their performance. Yoga is also capable of enhancing one’s breathing pattern, which
obviously plays an important role in the life of a swimmer. It also helps developing one’s
balance, which makes one glide in the water in a smooth and effortless manner. Yoga is also
good in making all parts of one’s body flexible. Thus, stretching for swimmers is vital in
extending one’s arms, shoulder blades, legs and feet easier than before. (Murugesan, T 2012).
The positive health outcomes of a consistent yoga practice that have been observed include enhanced physical performance and well-being, decrease in blood pressure, a decrease blood lipid values, a decrease in body mass index, as well as an improvement in pulmonary function. From a performance standpoint, yoga has been reported to enhance muscle torque,
increase in handgrip strength, decrease low back pain,delay the onset of muscle soreness
following strenuous activity,increase flexibility and balance as well as improved
cardiovascular performance.The impact of yoga has also been linked to improvements in
mental health. Such positive influences include reductions in anxiety, depression reduction,
enhanced the state of relaxation, and enhanced motivation.
15. References:
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McDermott KA, Rao MR, Nagarathna R, Murphy EJ, Burke A, Nagendra RH, et al. Ayoga
intervention for type 2 diabetes risk reduction: A pilot randomized controlled trial. BMC
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Pal A, Srivastava N, Tiwari S, Verma NS, Narain VS, Agrawal GG, et al. Effect of yogic
practices on lipid profile and body fat composition in patients of coronary artery disease.
Complement Ther Med 2011;19:122-7.
Parikh HN, Patel HM, Pathak NR, Chandwani S. Effect of yoga practices on respiratory
parameters in healthy young adults. Natl J Integr Res Med 2014;3:37-41.
Yadav RK, Das S. Effect of yogic practice on pulmonary functions in young females. Indian
J Physiol Pharmacol 2001;45:493-6.
Buśko K, Rychlik R. Changes of the maximal muscle torque in women training power yoga
(astanga vinyasa). Hum Mov 2006;2:168-77.
Reddy TP. Effect of yoga training on handgrip, respiratory pressures and pulmonary function.
Br J Sports Med 2010;44:i68.
Tilbrook HE, Cox H, Hewitt CE, Kang'ombe AR, Chuang LH, Jayakody S, et al. Yoga for chronic low back pain: A randomized trial. Ann Intern Med 2011;155:569-78.
Boyle CA, Sayers SP, Jensen BE, Headley SA, Manos TM. The effects of yoga training and a single bout of yoga on delayed onset muscle soreness in the lower extremity. J Strength Cond
Res 2004;18:723-9.
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Influence of pranayama on breath holding capacity and reaction time of junior state level elite
swimmers; Tusharkanti Bera, Kanchan Chourasia, Sanjay Uddhav Shete, Anita Vermayoga
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Sunil Hakked, Ragavendrasamy Balakrishnan*, Manjunath Nandi Krishnamurthy ; Journal of
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Effect of yoga and swimming on cognitive function in healthy adults: A randomized
controlled trial Shilpa S Gupta1, Manish V Sawane2 ; February 16, 2018
https://www.researchgate.net/publication/323362107
A comparative study of the effects of yoga & swimming on pulmonary functions in sedentary
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