| CTRI Number |
CTRI/2025/05/086462 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring The Link Between Breathing Strength, Body Measurements, And Heartburn |
|
Scientific Title of Study
|
Correlation Of Inspiratory Muscle Strength and Anthropometric Measurements Among People with Gastroesophageal Reflux Disease (GERD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjaykumar N |
| Designation |
UG STUDENT |
| Affiliation |
SRM Insitute of Science and Technology |
| Address |
Room no-PT 13, 5th floor,SRM College of Physiotherapy, SRM Institute of Science and Technology,Kattankulathur, Chengalpattu,Tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7904840528 |
| Fax |
|
| Email |
sanjaykumarn0528@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kaviya M |
| Designation |
ASSISTANT PROFFESOR |
| Affiliation |
SRM Insitute of Science and Technology |
| Address |
Room no- 14, Staff Room, 5th Floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9940513772 |
| Fax |
|
| Email |
kaviyam3@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Kaviya M |
| Designation |
ASSISTANT PROFFESOR |
| Affiliation |
SRM Insitute of Science and Technology |
| Address |
Room no- 14, Staff Room, 5th Floor, SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9940513772 |
| Fax |
|
| Email |
kaviyam3@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College Of Physiotherapy, SRMIST, Kattankulathur, Chengalpattu District-602203, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Sanjaykumar N |
| Address |
Room No-Pt 13,5th Floor, SRM College Of Physiotherapy, SRMIST, Kattankulathur, Chengalpattu District-602203, Tamil Nadu, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR N A RAJESH MD DM Gastro |
SRM Medical College Hospital and Research Centre |
C Block, Room No 26,4th Floor, Srm Medical College Hospital and Research Centre
Kancheepuram
TAMIL NADU |
9629006644
rajesha@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K219||Gastro-esophageal reflux disease without esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-65 years with clinically diagnosed GERD
BMI categorized as normal, overweight, or obese to evaluate the impact of varying anthropometric measures.
Subjects willing to undergo respiratory muscle strength tests and anthropometric measurements with consent
|
|
| ExclusionCriteria |
| Details |
Hiatal hernia
Nasal congestion on the day of assessment
Presence of comorbidities such as COPD, asthma, or cardiovascular disease.
Patient who underwent anti-reflex surgery.
Patient who underwent recent (within lat 6 month )abdominal surgery.
Pregnant women
Presence of Neurological/Neuromuscular disorders.
Any cognitive impairment/Psychological disorder.
Non comprehensive patients.
The patients who have undergone the endoscopy a week before.
Those on medication affecting respiratory or muscle function, such as bronchodilators or muscle relaxants
Recent lower limb fractures
Unstable cardiovascular status
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the impact of inspiratory muscle strength on the severity of GERD symptoms.
|
8-12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the correlation between Inspiratory muscle strength and anthropometric measurements (such as body mass index, waist circumference, waist hip ratio etc.) in patients with GERD.
To assess the Functional mobility of individuals with gastroesophageal reflux disease
|
8-12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
17/05/2025 |
| 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 Yet Recruiting |
| 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
|
The study will be proceeded after getting approval from the institutional ethical committee(IEC), The participants will be selected according to the inclusion and exclusion criteria, Informed consent will be obtained from the patients to ensure their willingness in this study, The research objectives will be explained to the participants in their regional language, After explanation each participant will be given the GERD-HRQL questionnaire, The patient will be assessed only after an hour from a meal, Each participant will be tested using the respiratory pressure meter to check their Inspiratory muscle strength MIP in cms H2O was measured with portable Respiratory Pressure Meter (Micro RPM),The subjects were seated with trunk at an angle of 90 degrees to the hip and feet on the ground. Subject used the nasal clip during all the manoevers. A nose clip was worn with normal mouth piece ensuring that there was no leak around the mouth piece. For MIP measurement ,the subjects were asked to make a maximal inspiratory effort starting from residual volume(RV), All the subjects performed three manoevers with effort and holding each for at least one second. One minute of rest was given between the efforts. The highest value recorded for MIP was taken for the purpose of data analysis ,The participant’s anthropometric measurement will be assessed, which includes height, weight, hip circumference and waist circumference ,From this collected data the BMI and waist-hip ratio of each participant will be calculated, The
participant’s functional mobility will be assessed using TUG
Test., The collected data is then analyzed and then the co-relation between Inspiratory muscle strength and anthropometric measurement will be found |