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CTRI Number  CTRI/2019/06/019761 [Registered on: 19/06/2019] Trial Registered Prospectively
Last Modified On: 14/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of anulom vilom breathing exercise on lung functions and capacity of performing physical activities in healthy adults across different age groups 
Scientific Title of Study   Efficacy of alternate nostril breathing on pulmonary functions and physical functional capacity in healthy adults across different age groups 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shilpasree Saha 
Designation  MPT student 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India

Ambala
HARYANA
133207
India 
Phone  8787528584  
Fax    
Email  shilpasreesaha6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vandana Esht PT 
Designation  Associate professor 
Affiliation  MMIPR,MM(DU),Mullana, Ambala, Haryana, India 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India

Ambala
HARYANA
133207
India 
Phone  8059930235  
Fax    
Email  vandanaesht@mmumullana.org  
 
Details of Contact Person
Public Query  
Name  Dr Vandana Esht PT 
Designation  Associate professor 
Affiliation  MMIPR,MM(DU),Mullana, Ambala, Haryana, India 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India

Ambala
HARYANA
133207
India 
Phone  8059930235  
Fax    
Email  vandanaesht@mmumullana.org  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar University, Mullana, Ambala, Haryana pin: 133207 
 
Primary Sponsor  
Name  MMIPR 
Address  MMIPR, MM(DU), Mullana, Ambala, Haryana, India  
Type of Sponsor  Private medical college 
 
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 
Shilpasree Saha  Maharishi Markandeshwar Hospital  Department of Physiotherapy, Division- Cardio-thoracic disorder, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation
Ambala
HARYANA 		 8787528584

shilpasreesaha6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alternate nostril breathing  Alternate nostril breathing is one of the type of breathing exercise techniques where both the nostrils are used alternately to complete the respiratory cycle. This is a phenomenon of alternating congestion and decongestion of erectile tissue of nasal terbunate and septum of both nostril. This effectively alters resistance of unilateral nose which effects the sympathetic and parasympathetic tone. Sympathetic vasoconstriction decreases air resistance which allow a greater passage of air while parasympathetic vasodilatation increases nasal resistance which decreases the airflow. The alteration may reach a point where air flow may be equal bilaterally. 
Comparator Agent  no intervention.  Patient will sit quite 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Healthy individual between 20-50 years of age.
2.Sedentary life style.
3.Voluntary participants.

 
 
ExclusionCriteria 
Details  1.Smokers & alcoholics.
2.Cardio-pulmonary disorders.
3.Diabetes.
4.Hypertension.
5.Neurological disorders.
6.Musculoskeletal disorders.
7.Body Mass Index ≥23 kg/m2 (Asia-pacific BMI). 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Spirometer  Outcome will be measured before and after 4 weeks of treatment. intervention will be given for 15 minutes daily for 4 weeks during morning 
 
Secondary Outcome  
Outcome  TimePoints 
Distance covered during 6 minutes walk test , Rate of perceived exertion on Modified Borgs scale  Outcome will be measured before and after 4 weeks of treatment. Intervention will be given for 15 minutes daily for 4 weeks during morning. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   20/08/2019 
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="1"
Months="0"
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  

Background: 

Alternate nostril breathing is a breathing technique in which both the nostrils are used alternately to inhale and exhale to complete a respiratory cycle.

Objective:

To evaluate the effect of alternate nostril breathing on forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC, peak expiratory flow rate (PEFR), peak inspiratory flow rate (PIFR), distance covered during 6 minutes walk test and rate of perceived exertion in healthy adults across different age groups.

Method:

Male and female patients of 20-50 years of age will be selected based on subject selection criteria. The samples will be taken by stratified random sampling and divided them into two stratas of different age groups. Then by randomization , both strata will divide into control and experimental groups. Experimental groups of both strata will receive alternate nostril breathing exercise for 15 minutes daily in morning for 4 weeks, while the control group will not perform anything. Measurement of FEV1, FVC, FEV1/FVC, PEFR, PIFR, distance covered during 6 minutes walk test and rate of perceived exertion will be recorded at baseline and after 4 weeks of intervention.

Result:

Data will be collected , entered and analysed by primary researcher. Normality test will be used to measure the normal distribution of data. Data will be analysed using SPSS version 21.0.  Level of significance will be set as 0.05.

Conclusion:

The present study will provide information about the efficacy of alternate nostril breathing on pulmonary funtion and physical funtional capacity in healthy adults across different age groups.

Keywords:

Alternate nostril breathing, pulmonary function, functional capacity.
 
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