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CTRI Number  CTRI/2024/08/071784 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 31/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Use of icing to check respiratory function among individuals with obesity 
Scientific Title of Study   Effect on Diaphragmatic Excursion and Strength following Quick Icing among people with Central Obesity associated with Diurnal Variations 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Kumar PT 
Designation  Assistant professor 
Affiliation  Lovely professional university 
Address  Lovely Professional University, Jalandhar Delhi G.T. Road, Phagwara, Punjab
Lovely Professional University, Jalandhar Delhi G.T. Road, Phagwara, Punjab
Jalandhar
PUNJAB
144411
India 
Phone  8572098743  
Fax    
Email  amit.28649@lpu.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Pooja Sunil Patil 
Designation  MPT Post Graduate Student (Neurology) 
Affiliation  Lovely Professional University 
Address  Lovely Professional University, Jalandhar Delhi G.T. Road, Phagwara, Punjab
Lovely Professional University, Jalandhar Delhi G.T. Road, Phagwara, Punjab
Jalandhar
PUNJAB
144411
India 
Phone  8010206014  
Fax    
Email  pp777167@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Kumar PT 
Designation  Assistant professor 
Affiliation  Lovely professional university 
Address  Lovely Professional University, Jalandhar Delhi G.T. Road, Phagwara, Punjab
Lovely Professional University, Jalandhar Delhi G.T. Road, Phagwara, Punjab
Jalandhar
PUNJAB
144411
India 
Phone  8572098743  
Fax    
Email  amit.28649@lpu.co.in  
 
Source of Monetary or Material Support  
Department of physiotherapy and paramedical sciences, Block 3, Room no 101 School of Allied Medical sciences, Lovely professional university,jalandhar,punjab,144411 India  
 
Primary Sponsor  
Name  Dr Amit Kumar PT 
Address  Department of physiotherapy and paramedical sciences, Block 3,Room no 101 school of Allied medical sciences, Lovely professional university Jalandhar, Punjab-144411 India 
Type of Sponsor  Other [Self] 
 
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 
Pooja Sunil Patil  Lovely Professional University Hospital  Department Of Physiotherapy and paramedical sciences, Block 3,Room no-405 School of Allied Medical Sciences, Lovely Professional University Jalandhar, Punjab -144411 India Jalandhar PUNJAB
Kapurthala
PUNJAB 
80810206014

pp777167@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, LOVELY PROFESSIONAL UNIVERSITY, PHAGWARA-PUNJAB-144411  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Obesity 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  -able to understand given commands
-BMI greater than 25
-Body temperature within normal limit
 
 
ExclusionCriteria 
Details  -Pregnant women
-psychological illness
-Hypo/Hyperthermic patients/subjects
-Any neurological conditions
-Any special conditions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Manual evaluation diaphragm scale (MED)
2. Manual muscle testing (MMT)
3. Electromyography (EMG) 
Week 1 and Week 4 
 
Secondary Outcome  
Outcome  TimePoints 
Axillary temperature with thermometer   Week 1 and Week 4 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   30/08/2024 
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="1"
Months="0"
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  

Background: The role of diaphragmatic function is of utmost importance in the attainment of optimal respiratory performance, particularly in individuals who are obese, particularly those who are centrally obese. There have been reports of variations in diaphragm function over the course of a day, thereby leading to investigations into the potential influence of environmental factors, such as rapid cooling, on the movement and strength of the diaphragm.

Aim and Objective: This study aims  to find the effect on diaphragmatic excursion and strength following quick icing among people with   central obesity associated with diurnal variation.  To evaluate the diaphragmatic excursion after quick icing associated with diurnal variation and to evaluate the diaphragmatic strength after quick icing associated with diurnal variations.

A total of 36 participants will be selected on the basis of inclusion and exclusion criteria. Pre-assessment will be taken using three primary outcome measures. these are MED scale, MMT and EMG. Participants will be recruited from Jalandhar, Punjab and Mumbai, Maharashtra. Demographic information will be taken whereas thoroughly explained about the rules and regulations of the study. Quick icing will be applied on two different times (morning and evening). Post assessment will be taken on 4th week.


 
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