| CTRI Number |
CTRI/2025/12/099808 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand how anxiety and fatigue affect physical functioning in patients with pneumonia |
|
Scientific Title of Study
|
Correlation between anxiety, fatigue and functional capacity in individuals with pneumonia - A cross sectional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shaik Siyadh |
| Designation |
PG Resident |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
KMCH College of Physiotherapy
SF 259 and 267 kalapatti post coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
6383039728 |
| Fax |
|
| Email |
shaiksiyadh6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Catherine Shalini |
| Designation |
Associate Professor |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
Department of Physiotherapy,
KMCH College of Physiotherapy,
Room no. 019, Sf no 259 267 kalapatti post coimbatore
College
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9894586624 |
| Fax |
|
| Email |
catherine@kmchphysiotherapy.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Catherine Shalini |
| Designation |
Associate Professor |
| Affiliation |
KMCH College of Physiotherapy |
| Address |
Department of Physiotherapy,
KMCH College of Physiotherapy,
Room no. 019, Sf no 259 267 kalapatti post coimbatore
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9894586624 |
| Fax |
|
| Email |
catherine@kmchphysiotherapy.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KMCH College of Physiotherapy |
| Address |
Sf no. 259 267 kalapatti post coimbatore Tamilnadu India. Pincode 641048 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shaik Siyadh |
KMCH Institute of Health Sciences and Research |
Department of Respiratory Medicine, Room no. 03,
99 Avinashi road coimbatore 641014
Coimbatore
TAMIL NADU |
6383039728
shaiksiyadh6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Commitee KMCH Institute of allied Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals diagnosed with pneumonia
2.Stable hemodynamic status
3.Patients who are willing to participate and give informed consent |
|
| ExclusionCriteria |
| Details |
1.Unstable cardiac conditions
2.Malignancy
3.History of chronic kidney failure, liver failure and organ transplantation
4.Recent cardio thoracic surgeries
5.Patients who were receiving psychiatric medications at the time of admission. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional capacity assessed by 6 minute walk test
Fatigue measured by fatigue severity scale
Anxiety assessed by General anxiety disorder questionnaire - 7 |
All the outcomes are assessed one time |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="91"
Sample Size from India="91"
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)
|
05/01/2026 |
| 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="8"
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
|
This study aims to assess the correlation between anxiety, fatigue and functional capacity in individuals with pneumonia. The outcomes measures are 6 minute walk test for assessing the functional capacity, fatigue severity scale to measure the fatigue level, and the generalized anxiety disorder -7 scale to assess the anxiety symptoms. All the outcome measures will be assessed at the evaluation time. |