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CTRI Number  CTRI/2024/04/065400 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Diaphragm Release Technique in Smokers & Non-Smokers: A Pilot Study 
Scientific Title of Study   Efficacy of Manual Diaphragm Release Technique on Transverse Abdominis Activation & Chest Expansion among Smokers and Non Smokers- A Pilot Study  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  LAKSHAY ATTRI 
Designation  Bachelor of Physiotherapy final year Student 
Affiliation  Galgotias University 
Address  Room No B-304, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone    
Fax    
Email  lakshay.20smas1010080@galgotiasuniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  TANYA GUJRAL 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  Room No B-315, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  09311020220  
Fax    
Email  tanya.gujral@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  TANYA GUJRAL 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  Room No B-315, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  09311020220  
Fax    
Email  tanya.gujral@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
Research and Development cell, Room No B-316, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar 
 
Primary Sponsor  
Name  Research and Development cell Galgotias University 
Address  Room No B-316, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar 
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 
Dr Tanya Gujral  Galgotias University  Room No E-004, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 9311020220

tanya.gujral@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DEPARTMENTAL RESEARCH COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Smokers and non smokers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Manual Diaphragm Release Technique  The subject will be made to lie supine in comfortable position. Knees will be bent and hands on the side. The therapist will be standing above the head side of bed. The hands of the therapist will be slightly lateral to the xiphisternum, clasping the lower ribs by holding the lower edge with the tip of the fingers curved and carefully introducing fingers under the costal margins. The subject will be asked to breathe in and while exhaling, the pressure of clasping will be increased maintaining it through next exhalation and increasing it further, maintaining a cephalic traction. This will be done for twice a week for 4 weeks. 
Comparator Agent  Non smokers  The subject will be made to lie supine in comfortable position. Knees will be bent and hands on the side. The therapist will be standing above the head side of bed. The hands of the therapist will be slightly lateral to the xiphisternum, clasping the lower ribs by holding the lower edge with the tip of the fingers curved and carefully introducing fingers under the costal margins. The subject will be asked to breathe in and while exhaling, the pressure of clasping will be increased maintaining it through next exhalation and increasing it further, maintaining a cephalic traction. This will be done for twice a week for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Male 
Details  1.Having decreased Transverse Abdominis recruitment i.e.
a. DMC score 0-5
b. PBU score more than 68mmHg i.e either increase in pressure or decrease only up to 2 mmHg from 70 mmHg
2.4) Willing to participate voluntarily in the study
 
 
ExclusionCriteria 
Details  1.History of recent trauma around back or chest area
2.History of recent fracture in spine or ribs
3.History of back or neck pain in past 1 year.
4.History of back, abdominal or cardiac Surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Deep Muscle Contraction Scale
2.Pressure Biofeedback Unit
3.Chest Expansion
 		 Baseline and after 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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 3 
Date of First Enrollment (India)   24/04/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Pilot study will be done with random sampling method. 52 healthy subjects assigned equally in 2 groups 26 in each group. Primary outcome measure will be Transversus Abdominis recruitment using Deep Muscle Contraction Scale,Pressure Biofeedback unit and Chest Expansion. Group A of smokers will receive Manual Diaphragm Release Technique as 6 sittings. Group B of non smokers will receive Manual Diaphragm Release Technique as 6 sittings.After 2 weeks, TRANSVERSUS Abdominis muscle activation and Thoracic expansion will be checked. 
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