| CTRI Number |
CTRI/2024/12/078142 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [App based trial] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pulmonary Rehabilitation in Pneumonia patients |
|
Scientific Title of Study
|
Optimising Pulmonary Recovery-An App Based Study On Improving Pulmonary Functions In Patients With Pneumonia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RENUGADEVI V |
| Designation |
Post graduate General medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room no:01, Department of General Medicine,Saveetha Medical College and Hospital ,Saveetha Nagar, Thandalam, Chennai TAMIL NADU
Room no:01,Department of General Medicine ,Saveetha Nagar, Thandalam, Chennai TAMIL NADU
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9566999917 |
| Fax |
|
| Email |
reshmav218@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GUNASEKARAN |
| Designation |
Post graduate General medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room number :01,Saveetha Medical College and Hospital ,Saveetha Nagar, Thandalam, Chennai TAMIL NADU
Room number :01,Saveetha Medical College and Hospital Saveetha Nagar, Thandalam, Chennai TAMIL NADU
602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
09884398420 |
| Fax |
|
| Email |
drguna59@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RENUGADEVI V |
| Designation |
Post graduate General medicine |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Room Number:01,Department of General Medicine,Saveetha Medical College and Hospital ,Saveetha Nagar, Thandalam, Chennai TAMIL NADU
Room Number:01,Department of General Medicine Saveetha Nagar, Thandalam, Chennai TAMIL NADU
602105
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9566999917 |
| Fax |
|
| Email |
reshmav218@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha medical college and hospital,saveetha nagar,Thandalam Chennai-602105,Tamil nadu,India |
|
|
Primary Sponsor
|
| Name |
Saveetha medical college and hospital |
| Address |
Saveetha Nagar,Thandalam,chennai,tamil nadu 602105 |
| 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 |
| DrRenugadevi |
Saveetha medical college and hospital |
Room number -01,Department of General Medicine ,Saveetha nagar,Thandalam kancheepuram district,chennai-602105
Kancheepuram
TAMIL NADU |
9566999917
reshmav218@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha medical college and hospital Institutional Ethics committee |
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 |
An app based study on improving pulmonary functions |
Pulmonary rehabilitation in patients with pneumonia
Duration:3 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1,Adult patients (18 years and older) diagnosed with pneumonia.
Patients admitted to the designated hospital for treatment of pneumonia.
2,Confirmed diagnosis of pneumonia based on clinical symptoms, radiological findings, and/or laboratory tests.
3,Willingness and ability to participate in the study, including the ability to use a smartphone or access to a caregiver who can assist with app usage.
4,Patients who are clinically stable and able to undergo 6 minutes walt test,spirometry
|
|
| ExclusionCriteria |
| Details |
1,Patients with pre-existing chronic lung diseases (e.g., COPD, asthma) that may confound pulmonary function test results.
2mPatients with significant comorbidities or medical conditions that may interfere with the study objectives or limit life expectancy.
3,Patients with cognitive impairments or language barriers that may hinder understanding or adherence to the app-based intervention.
4,Patients with contraindications to pulmonary function testing or unable to perform spirometry or lung volume measurements.
5,Non smoker
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluating the effectiveness of app based interventions against conventional methods pulmonary functions among patients recovering from pneumonia by measuring the pulmonary function test before and after pulmonary rehabilitation
|
Evaluating the effectiveness of app based interventions against conventional methods pulmonary functions among patients recovering from pneumonia by measuring the pulmonary function test before and after pulmonary rehabilitation from the date of discharge After 3 months i.e., 12 weeks of duration
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptoms evaluated by Borgs dyspnea scale,QOL improvement after the pulmonary rehabilitation |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
18/12/2024 |
| 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="3"
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 explores the effectiveness of an app-based intervention in improving pulmonary recovery for pneumonia patients, addressing the persistent respiratory symptoms and impaired lung function many survivors face post-treatment. Despite adequate medical care, these issues often lead to reduced quality of life and increased healthcare utilization, creating a need for innovative recovery solutions. The trial aims to assess the impact of the app on pulmonary function (e.g., peak flow and 6-minute walk test), patient-reported outcomes (such as respiratory symptoms, quality of life, and treatment adherence), and its feasibility and acceptability among patients and healthcare providers. Adult pneumonia patients will be randomly assigned to either the intervention group, which will use the app for respiratory exercises and symptom monitoring, or the control group receiving standard care. Results will be analyzed through both quantitative methods (e.g., statistical comparisons) and qualitative feedback from interviews. It is expected that the app-based intervention will lead to improved pulmonary function, better symptom management, and enhanced quality of life for patients, offering a promising alternative for post-pneumonia recovery. |