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CTRI Number  CTRI/2024/11/077447 [Registered on: 28/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Correlation between ability to do activities of daily living and respiratory muscle strength in individuals with normal weight and high fat percentage. 
Scientific Title of Study   Correlation between functional capacity and respiratory muscle strength in adults with normal-weight obesity syndrome. 
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 Hetal Mistry 
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD-24,Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  9892971248  
Fax    
Email  hetalmistry1975@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hetal Mistry 
Designation  Assistant Professor 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD-24,Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  9892971248  
Fax    
Email  hetalmistry1975@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Priyanka Ghumnani 
Designation  Post Graduate Student 
Affiliation  Topiwala National Medical College and B.Y.L. Nair Charitable Hospital 
Address  OPD-24, Physiotherapy department, P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Dr. A.L. Nair Road, Mumbai Central, Mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  8668346042  
Fax    
Email  priyankaghumnani01@gmail.com  
 
Source of Monetary or Material Support  
P.T School & Centre, Topiwala National Medical College and B.Y.L. Nair Charitable Hospital, Mumbai Maharashtra 400008 India 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 Hetal Mistry  P.T School & Centre, T.N.M.C & B.Y.L Ch Nair Hospital  OPD no.24, Physiotherapy department, M building,Topiwala National Medical College and B.Y.L. Nair Charitable Hospital.Dr. A.L. Nair Road, Mumbai Central, Mumbai Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 
9892971248

hetalmistry1975@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects (ECARP) PG Academic committee T. N. Medical College and BYL Nair Ch. Hospital.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal-weight obesity syndrome 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  1 Both males and females
2 Age group of 18 to 35 years
3 BMI less than 24.9 kg per meter square
4 Males having body fat percentage greater than 25 percent and females having body fat percentage greater than 35 percent according to WHO. 
 
ExclusionCriteria 
Details  1 Those with major respiratory, musculoskeletalor neurological diseases
2 Smokers or recent quitters
3 Assistive aids for walking
4 Professional athletes
5 Patients unable to understand and follow the verbal commands
6 Major audio-visual impairment
7 Systolic blood pressure more than 180 mmhg
8 Resting Diastolic blood pressure more than 100 mmhg
9 Resting HR more than 120 bpm
10 Not willing to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Six-minute walk test(6MWT)
2. Maximum Inspiratory Pressure and Maximum Expiratory Pressure 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   05/12/2024 
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="6"
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  
NEED OF STUDY 
Normal weight obesity elevates the likelihood of developing non-communicable diseases, metabolic syndrome, and cardiovascular-related mortality. 

According to Lana P. Franco, Carla C. Moris, it is crucial to characterize the normal-weight obesity syndrome and recognize the risks associated to health since, body composition assessment is usually not conducted in outpatient settings. Clarity about diagnosis, prevalence and the clinical effects of normal-weight obesity syndrome will aid healthcare providers in integrating targeted measures into healthcare plans. This includes periodically assessing adiposity, even among those with adequate BMI, to preserve health and minimize disease risks within normal-weight obese populations.

 People who have normal-weight obesity are not noticeably different from those who have normal weight without excess fat when using regular check-up methods. This makes it hard to identify them and create health- improving plans. Therefore, it’s important to make a strong effort to understand their physical fitness as it can provide insights into the impact of excess body fat on the respiratory system despite appearing to have a normal weight. 
Understanding how respiratory muscle strength relates to functional capacity could help in revealing potential health risks associated with normal weight-obesity and its effects on respiratory function, which might not be evident based solely on BMI measurements. It will also help in development of targeted interventions or exercise programs to improve both functional capacity and respiratory muscle strength in this specific population. 

Conducting this study in the age group 18 to 35 is particularly relevant as it addresses a critical phase of adulthood when lifestyle habits and health patterns are often established. This study can provide insights into early indicators of health risks associated with normal weight obesity. 

 Examining this correlation can contribute to a deeper understanding of how normal weight obesity affects overall health, potentially identifying early markers of respiratory issues. Additionally, the results may also provide guidance for public health programmes aimed at promoting a holistic approach to well-being in this specific population. 
 
Therefore, our aim is to study the correlation between functional capacity and respiratory muscle strength in adults with normal-weight obesity syndrome

AIM 
The aim of the study is to find out the correlation between functional capacity and respiratory muscle strength in adults with normal-weight obesity syndrome. 
 
OBJECTIVES 
 1.To assess functional capacity in adults with normal-weight obesity syndrome.
 2.To assess respiratory muscle strength in adults with normal-weight obesity syndrome.
 3.To find correlation between functional capacity and respiratory muscle strength in adults with normal-weight obesity syndrome.

PROCEDURE
Participants will be included in the study after screening for the inclusion and exclusion criteria. 

Body fat percentage will be measured by skinfold thickness measurement according to ACSM guidelines. 
 
 A written consent will be obtained from the participants after explaining the study procedure in detail. 
 
 Basic demographic details, anthropometric measures, vital parameters, comorbidity details will be taken. 
 
 Respiratory muscle strength will be assessed by using respiratory pressure meter and three readings will be taken of maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP).
 
 Vitals will be measured (HR, BP, RR, SPO2, RPE) and participant will then be made to perform the Six Minute Walk Test on the same day. The participants will be under observation throughout the test and vitals will be measured immediately after completion of test. 
  
 All data obtained from the participants will be kept confidential. 
 
 Data will be collected and analyzed.

DATA MANAGEMENT AND ANALYSIS
 All the data obtained from the participants will be kept confidential. Both hard and soft copy will be maintained. The data will be stored in excel sheets for analysis. Graph pad or SPSS software will be used for analysis.
 PLAN FOR STATISTICAL ANALYSIS 
The data will be entered in excel sheets for analysis. 
Functional capacity will be assessed by 6-minute walk test and descriptive analysis will be done.  
Respiratory muscle strength will be assessed by measuring Maximum Inspiratory Pressure and Maximum Expiratory 
Pressure (by using respiratory pressure meter) and descriptive analysis will be done.  Data will be tested for normality. 
If the data passes the normality test, parametric–Pearson correlation test will be used. 
If the data does not pass normality test, non-parametric- Spearman correlation test will be used

 
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