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CTRI Number  CTRI/2020/02/023366 [Registered on: 17/02/2020] Trial Registered Prospectively
Last Modified On: 04/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Yoga]  
Study Design  Single Arm Study 
Public Title of Study   The Effect of Yoga on Various Body Functions 
Scientific Title of Study   The Effect of Yoga Practices on Pulmonary Function, Cardiovascular and Autonomic variables, Body Composition, Hydration Status and Cognitive Function in College Athletes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Susan SV 
Designation  PG Student 
Affiliation  Center for Integrative Medicine and Research 
Address  PG Student Division of Yoga, CIMR, MAHE, Manipal
Division of Yoga, CIMR, MAHE, Manipal
Udupi
KARNATAKA
576104
India 
Phone  7736211763  
Fax    
Email  drsusansv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Annapoorna K 
Designation  PG Student 
Affiliation  Center for Integrative Medicine and Research 
Address  Head of Department, Division of Yoga, CIMR, MAHE, Manipal
Division of Yoga, CIMR, MAHE, Manipal
Udupi
KARNATAKA
576104
India 
Phone  9845526727  
Fax    
Email  annapoorna.k@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Susan SV 
Designation  PG Student 
Affiliation  Center for Integrative Medicine and Research 
Address  Division of Yoga, CIMR, MAHE, Manipal
Division of Yoga, CIMR, MAHE, Manipal
Udupi
KARNATAKA
576104
India 
Phone  7736211763  
Fax    
Email  drsusansv@gmail.com  
 
Source of Monetary or Material Support  
Institutional Funds for PG Thesis, Center for Integrative Medicine and Research, Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  Center for Integrative Medicine and Research  
Address  Manipal Academy for Higher Education, Manipal, Karnataka 
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 
Dr Susan SV  Division of Yoga  Divison of Yoga, 1st floor, Dormitory Building, Kasturba Hospital Manipal 576104
Udupi
KARNATAKA 
7736211763

drsusansv@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  NIL  NIL 
Intervention  Yoga  There will be 5 Yoga sessions per week for 4 weeks. Each Yoga Session is for 45mins: a) Asana (25mins): 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 b) Pranayama: (10 mins) 10 rounds of each breathing technique are practiced. 1. Anulomaviloma Pranayama 2. Suryabhedana Pranayama 3. Bhramari Pranayama c) Relaxation (10 mins) 1. Makarasana 2. Shavasana 1 3. Shavasana 0 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Play an outdoor sport 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 during deep breathing
Blood pressure response to Isometric Hand-Grip
Heart rate and Blood Pressure response to standing - Orthostatic Test
Body Mass Index
Body Fat percentage
Body Fat Mass
Fat Free Mass
Total Body Water
Letter Cancellation Tasks score
Digit Cancellation Tasks score
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)   20/02/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
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 College Athletes

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 college athletes.

Objectives:
To assess pulmonary function, cardiovascular and autonomic variables, body composition, hydration status and cognitive function in healthy college athletes.
To compare the effects of post- yoga intervention in healthy college athletes.

Hypotheses: NA

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 athletic and academic performance, stress reduction, disease prevention, 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 and Labchart 8 Pro software to measure Heart rate, Blood pressure, ECG and Autonomic function
5) Computerized spirometry VO3b, 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
8) Letter Cancellation Tasks and Digit Cancellation tasks for the assessment of visuospatial function and attention 9) Trail making Test 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
Play an outdoor sport 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): NA. This project involves non-invasive intervention and analysis.

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
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. Suryabhedana Pranayama
3. Bhramari Pranayama

c) Relaxation
1. Makarasana
2. Shavasana 1
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 during deep breathing
Blood pressure response to Isometric Hand-Grip
Heart rate and Blood Pressure response to standing - Orthostatic Test
Body Mass Index
Body Fat percentage
Body Fat Mass
Fat Free Mass
Total Body Water
Letter Cancellation Tasks score
Digit Cancellation Tasks score
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. Time needs to be spared daily for the sake of yoga. There is a risk of pain and discomfort if instructions are not followed properly.
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:

Rs.10,000; Institutional funds for PG Thesis

14. Review of literature (within 1000 words):

Since the twentieth century, Yoga, a spiritual practice has been applied in the health sector for physical fitness and therapeutic intervention. It is a theistic philosophical system that aims to control the fluctuations of the mind through a range of practices involving the body and willful control of the breath. (Iyengar, 1966). A typical yoga routine includes physical postures (asana), breathing practices (pranayama) and relaxation adopted for reasons including general wellness, physical exercise, and stress management (Quilty et al, 2013).

A regular asana practice is an ideal complement to other forms of exercise as it works in the sagittal, frontal and transverse planes, ensuring all-rounded development. One learns to stay focused through uncomfortable poses by concentrating on even inhalations and exhalations. (Kumar, 2014). Pranayama practices have been identified as feasible training methods (Kondam, 2012) that increase respiratory efficiency. A combination of asanas, pranayama and relaxation have shown significant improvement in parameters of lung function (Parikh et al, 2014; Doijad et al, 2012; Yadav et al, 2001; Makwana et al, 1988). The improvement in vital capacity could be attributed to increase in strength of respiratory musculature (Joshi et al, 1998). Integrated Yogic practices improve autonomic regulation and vagal dominance (Khalsa, 2004), suggesting that Yoga can be useful for the prevention of stress-related disorders and health promotion. Changes in heart rate variability with yoga may reflect resonance effects between respiratory muscle contractions, heart rate and baroreflex activity that enhance autonomic efficiency (Tyagi et al, 2016). Yoga shows decrease in blood lipid values (Pal, 2011) body mass index (McDermott, 2014), and percentage of body fat (Gharote, 1977; Himashree et al, 2016). Movements in yoga involve repeated contractions and relaxations of the abdominal muscles, possibly causing reduction of body fat (Manna, 2018).

From a standpoint of athletic performance, yoga has been reported to increase muscle torque (Buśko, 2006), handgrip strength (Reddy, 2010), flexibility, balance (Boehde, 2005; Polsgrove, 2016) decrease low back pain (Tilbrook et al, 2011) and delay the onset of muscle soreness following strenuous activity (Boyle,2004). The positive effect of Yoga is being established through findings such as improvement in muscular strength, body composition, cardiorespiratory fitness, sleep pattern and quality of life. Practitioners report reduction in stress, anxiety, depression, chronic pain (Woodyard, 2011), and increased state of relaxation (Kulmatycki, 2012) and motivation (Donohue, 2006). The positive impact of yoga on processing speed, hand steadiness, and visual and spatial memory (Telles et al, 1993; Naveen et al, 1997; Rangan et al,2009) have been documented in school children and women (Nobjari et al, 2019) suggestive of enhanced attention and concentration. Yoga improves the ability of the individual to control visual distraction, increasing the ability for pre-potent inhibition (Chan, 2007), reducing planning time, and improving execution time (Manjunath and Telles, 2001), thereby improving performance on the given task (Bhuyan and Mishra, 2013).

Although there is a lack of clarity regarding specific yoga practices involved, current literature suggests yoga influences body composition, pulmonary, cardiac, autonomic, and cognitive function. The effects of traditional yoga practices on parameters such as breath holding capacity, orthostatic blood pressure and hydration status have not been studied, opening possibilities for more rigorous research.

15. References:

Bhuyan B, Mishra PK. 2013. Effects of yoga on performance in a letter-cancellation task under academic examination stress. IOSR Journal of Research & Method in Education e-ISSN: 2320–7388, p-ISSN: 2320–737X Volume 2, Issue 5, PP 34-37.

Boehde D, Porcari J, Greany J, Udermann B, Johanson D, Foster C. The physiological effects of 8 weeks of yoga training. J Cardiopulm Rehabil Prev 2005;5:290.

Boyle CA, Sayers SP, Jensen BE, Headley SA, Manos TM. 2004. The effects of yoga training and a single bout of yoga on delayed onset muscle soreness in the lower extremity. J Strength Cond Res;18:723-9.

Buśko K, Rychlik R. 2006. Changes of the maximal muscle torque in women training power yoga. Hum Mov;2:168-7

Chan D, Woollacott M. 2007. Effects of level of meditation experience on attentional focus: is the efficiency of executive or orientation networks improved. J Altern Complement Med 13:651–7.

Doijad VP, Surdi AD. 2012. Effect of short term yoga practice on pulmonary function tests. Indian Journal of Basic and Applied Medical Research. 1(3): 226-230.

Donohue B, Miller A, Beisecker M, Houser D, Valdez R, Tiller S, et al. 2006. Effects of brief yoga exercises and motivational preparatory interventions in distance runners: Results of a controlled trial. Br J Sports Med;40:60-3

Gharote ML. 1977. An evaluation of the effect of yogic treatment on obesity - a report. Yoga-Mimamsa; 19 (I): 13-37.

Iyenger BKS. 2006. Light on Yoga. Allen & Unwin.

Joshi LN, Joshi VD, Gokhale LV. 1992. Effect of short term pranayama practice on breathing rate and ventilator functions of lung. Indian J Physiol Pharmacol.;36(2):105-8. Khalsa SB. 2004. Yoga as a therapeutic intervention: A bibliometric analysis of published research studies. Indian J Physiol Pharmacol;48:269–85.

Kondam A, Kumar, Vijay & Prasad, Vijay. 2012. A study to evaluate the effect of vital capacity (VC), forced vital capacity (FVC) and peak expiratory flow rate (PEFR) in subjects practicing pranayama. IJCRR Vol 04 issue 19.

Kulmatycki L, Bukowska K. 2007. Differences in experiencing relaxation by sport coaches in relation to sport type and gender. Hum Mov;8:2, 98-103.

Kumar A. Benefits of Yoga in sports - A study, IJMRD 2014; 1(7): 67-69

Makwana K, Khirwadkar N, Gupta HC. 1988. Effect of Short term yoga practice on ventilatory function tests. Indian J Physiol Pharmacol; 32(3):202-8.

Manjunath NK, Telles S. 2001. Improved performance in the Tower of London test following yoga. Indian J Physiol Pharmacol 45:351–4. Manna I. 2018. Effects of Yoga Training on Body Composition and Oxidant-Antioxidant Status among Healthy Male. International journal of yoga, 11(2), 105–110.

McDermott KA, Rao MR, Nagarathna R, Murphy EJ, Burke A, Nagendra RH, et al. 2014. A Yoga intervention for type 2 diabetes risk reduction: A pilot randomized controlled trial. BMC Complement Altern Med;14:212.

Naveen KV, Nagarathna R, Nagendra HR, Telles S. 1997 Yoga breathing through a particular nostril increases spatial memory scores without lateralized effects. Psychol Rep 81:555–61.

Nobjari M & Tahmasebi S. 2019. Improvement of women’s visual memory during 36-session intervention based on yoga

Pal A, Srivastava N, Tiwari S, Verma NS, Narain VS, Agrawal GG, et al. 2011. Effect of yogic practices on lipid profile and body fat composition in patients of coronary artery disease. Complement Ther Med;19:122-7.

Parikh HN, Patel HM, Pathak NR, Chandwani S. 2014. Effect of yoga practices on respiratory parameters in healthy young adults. Natl J Integr Res Med;3:37-41.

Polsgrove MJ, B M Eggleston, Roch J Lockyer. 2016. Impact of 10 Weeks Yoga Practice on Flexibility and Balance Of College Athletes, Int J Yoga. Jan-Jun;9(1):27-34.

Quilty, M. T., Saper, R. B., Goldstein, R., & Khalsa, S. B. 2013. Yoga in the Real World: Perceptions, Motivators, Barriers, and patterns of Use. Global advances in health and medicine, 2(1), 44–49.

Rangan, R., Nagendra, H., & Bhat, G. R. (2009). Effect of yogic education system and modern education system on memory. International journal of yoga, 2(2), 55–61. doi:10.4103/0973-6131.60045

Reddy TP. 2010. Effect of yoga training on handgrip, respiratory pressures and pulmonary function. Br J Sports Med;44:i68.

Telles S, Hanumanthaiah B, Nagarathna R, Nagendra HR. 1993. Improvement in static motor performance following yogic training of school children. Percept Mot Skills 76:1264–6.

Tilbrook HE, Cox H, Hewitt CE, Kang’ombe AR, Chuang LH, Jayakody S. 2011. Yoga for chronic low back pain: A randomized trial. Ann Intern Med; 155:569-78.

Tyagi, A., & Cohen, M. 2016. Yoga and heart rate variability: A comprehensive review of the literature. International journal of yoga, 9(2), 97–113.

Yadav RK, Das S. 2001. Effect of yogic practice on pulmonary functions in young females. Indian J Physiol Pharmacol; 45:493-6.
 
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