Exploring The Link Between Breathing Strength, Body Measurements, And Heartburn

Not yet recruiting

Conditions: Gastro-esophageal reflux disease without esophagitis,

Registration Number: CTRI/2025/05/086462

Lead Sponsor: Sanjaykumar N

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, Theparticipant’s functional mobility will be assessed using TUGTest., The collected data is then analyzed and then the co-relation between Inspiratory muscle strength and anthropometric measurement will be found

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the impact of inspiratory muscle strength on the severity of GERD symptoms.	8-12 WEEKS

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): SRM Medical College Hospital and Research Centre
🇮🇳
Kancheepuram, TAMIL NADU, India
SRM Medical College Hospital and Research Centre
🇮🇳Kancheepuram, TAMIL NADU, India
DR N A RAJESH MD DM Gastro
Principal investigator
9629006644
rajesha@srmist.edu.in