| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F451||Undifferentiated somatoform disorder, |
|
|
Intervention / Comparator Agent
|
|
|
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
|
|
|
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. |