| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obesity |
|
|
Intervention / Comparator Agent
|
|
|
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.
|