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CTRI Number  CTRI/2024/11/076841 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 24/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Checking lung health and strength of breathing muscles in people with Anxiety disorder 
Scientific Title of Study   Evaluation of Pulmonary Function and Inspiratory Muscle Strength in Individuals with Anxiety Disorder.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shraddha S 
Designation  Post graduate student 
Affiliation  Ramaiah college of physiotherapy - RUAS  
Address  Ramaiah college of physiotherapy (Department of Physiotherapy) Ramaiah university of applied sciences MS Ramaiah Nagara, MSRIT Post, Bangalore - 560054

Bangalore
KARNATAKA
560054
India 
Phone  8792843946  
Fax    
Email  drshraddha.s99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Veena Kiran Nambiar 
Designation  Professor 
Affiliation  Ramaiah college of physiotherapy - RUAS  
Address  Ramaiah college of physiotherapy (Department of Physiotherapy) Ramaiah university of applied sciences, MS Ramaiah Nagara, MSRIT Post, Bangalore - 560054

Bangalore
KARNATAKA
560054
India 
Phone  9880575407  
Fax    
Email  veenakn.rcp@msruas.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Veena Kiran Nambiar 
Designation  Professor 
Affiliation  Ramaiah college of physiotherapy - RUAS  
Address  Ramaiah college of physiotherapy, (Department of Physiotherapy) Ramaiah university of applied sciences, MS Ramaiah Nagara, MSRIT Post, Bangalore - 560054

Bangalore
KARNATAKA
560054
India 
Phone  9880575407  
Fax    
Email  veenakn.rcp@msruas.ac.in  
 
Source of Monetary or Material Support  
Ramaiah college of physiotherapy, M S Ramaiah nagara, MSRIT POST, Bangalore - 560054 
Ramaiah medical and college hospital, M S Ramaiah nagara, MSRIT POST, Bangalore - 560054 
Ramaiah memorial hospital, M S Ramaiah nagara, MSRIT POST, Bangalore - 560054 
 
Primary Sponsor  
Name  Shraddha S 
Address  Ramaiah college of physiotherapy, M S Ramaiah nagara, MSRIT POST, Bangalore - 560054 
Type of Sponsor  Other [NIL] 
 
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 Shraddha S   Ramaiah medical college and hospital  Department of Physiotherapy M S Ramaiah nagara, MSRIT post, Bangalore - 560054
Bangalore
KARNATAKA 
8792843946

drshraddha.s99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethics committee MS Ramaiah college and hospitals  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F451||Undifferentiated somatoform disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients with anxiety disorder
social anxiety disorder and generalised anxiety disorder with or without panic attack diagnosed by Psychiatrist.
Anxiety disorder 3 months to 5 years
 
 
ExclusionCriteria 
Details  known case of pulmonary disorders
known case of neuromusculoskeletal disorders
Individuals who are unable to comply with study procedures
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pulmonary function test
respiratory pressure meter
 
baseline - one time
 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/11/2024 
Date of Study Completion (India) 31/07/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/07/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Yet to publish  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Anxiety disorder is a mental health condition characterized by persistent, excessive worry and fear accompanied by physical tension and other behavioral and cognitive symptoms for several months. It can interfere with activities of daily living and impair individual’s personal and professional life.  Normally, anxiety leads individuals to tense up their muscles and activate their sympathetic and, to lesser extent, parasympathetic neural systems. The autonomic activation leads to increased respiratory rate, heart rate, blood pressure, and sweat gland activity. Anxiety can possibly alter the breathing pattern increasing muscle tension, leading to weakness and affecting overall physical functionality. Limited research has demonstrated the influence of ongoing persistent anxiety on respiratory function and respiratory muscle strength. Pulmonary function test (PFT) and maximal inspiratory pressure (MIP) are helpful tools to evaluate pulmonary function and inspiratory muscle strength. These values can serve and may help improve patient outcomes. Anxiety disorders are generally associated with psychological changes; therefore, this study aims to demonstrate physiological changes in respiratory system.  

 
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