| CTRI Number |
CTRI/2025/01/079833 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors that increase the risk of flare ups in Chronic Obstructive Pulmonary Disease Patients |
|
Scientific Title of Study
|
Predictors of Severe Exacerbation in Chronic Obstructive Pulmonary Disease Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahima mayee Tripathy |
| Designation |
MPT Cardiopulmonary Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no: 110, Cardiopulmonary Lab, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025
South
DELHI
110025
India |
| Phone |
8527727837 |
| Fax |
|
| Email |
mahima.tripathy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aqsa Mujaddadi |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room No: 103, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025
South
DELHI
110025
India |
| Phone |
8130676908 |
| Fax |
|
| Email |
aqsamuj786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahima mayee Tripathy |
| Designation |
MPT Cardiopulmonary Student |
| Affiliation |
Jamia Millia Islamia |
| Address |
Room no: 110, Cardiopulmonary Lab, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025
South
DELHI
110025
India |
| Phone |
8527727837 |
| Fax |
|
| Email |
mahima.tripathy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metro Centre for Respiratory Diseases, Metro Hospitals and Heart Institute, Sector-11, Noida-201301 |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Metro Centre for Respiratory Diseases |
Metro Centre for Respiratory Diseases, Metro Hospitals and Heart Institute, Sector-11, Noida-201301 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahima mayee Tripathy |
Metro Centre for Respiratory Diseases, Metro Hospitals and Heart Institute |
Metro Centre for Respiratory Diseases, Metro Hospitals and Heart Institute, Sector-11, Noida-201301
Gautam Buddha Nagar
UTTAR PRADESH |
8527727837
mahima.tripathy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Metro Ethical Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age is 40 years to 80 years.
Sex is Males and Females.
Participants had a clinical diagnosis of COPD confirmed by spirometry value FEV1/FVC less than 0.70 and a grade II, III, or IV airflow limitation according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. The grades of the COPD classified as moderate GOLD Stage II where FEV1 greater than or equal to 50% predicted but less than 80% predicted, severe GOLD Stage III where FEV1 is greater than or equal to 30% predicted but less than 50% predicted, very severe GOLD Stage IV where FEV1 is less than 30% predicted.
Patients who are hospitalised for severe exacerbation of COPD experience worsening symptoms for a duration of less than 2 weeks. |
|
| ExclusionCriteria |
| Details |
Patients with additional active inflammatory diseases such as Rheumatoid Arthritis, Systemic Lupus Erythematous, Fibromyalgia, and Inflammatory Bowel Syndrome.
The patient presented with Myopathy.
Patients with other obstructive pulmonary diseases such as Asthma, Asthma-COPD Overlap Syndrome (ACOS).
Patient who had Unstable Angina and Acute Myocardial Infraction. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Respiratory Muscle Strength |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Six-Minute Walk Tests (6-MWT)
Pulmonary Function Tests (PFT)
Arterial Blood Gas Analysis (ABG) |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
09/02/2025 |
| 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="2"
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
|
Objective: To investigate the predictive ability of respiratory muscle strength, functional capacity, pulmonary function, and arterial blood gas analysis for severe exacerbation in patients with COPD.Study Design: The study will employ a retrospective, cross-sectional study design. Sample: Retrospective data will be taken from Metro Hospitals and Heart Institute, Noida, India. Sample size: The total sample size for the present trial will be 102. Independent Variable: Respiratory Muscle Strength Functional Capacity Pulmonary Lung Tests Arterial Blood Gas Analysis Dependent Variable: Severe acute exacerbation of COPD (AECOPD) Covariates Adjustment will be done. Statistical Analysis: Regression analysis.
|