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CTRI Number  CTRI/2025/02/080678 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Pulmonary Rehabilitation Program for Patient with Chronic Obstructive Pulmonary Disease: A Prospective Analytical Study  
Scientific Title of Study   Pulmonary Rehabilitation Program for Patient with Chronic Obstructive Pulmonary Disease 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrShivam Srivastava 
Designation  PhD Scholar and Cardio Pulmonary Physiotherapist  
Affiliation  King Georges Medical University, UP, Lucknow (India) 
Address  House Number 68, Chandrika Vihar Lane Two, Gudamba, Kursi Road, Lucknow-226026, Uttar Pradesh, India
King Georges Medical University, UP, Lucknow, Chowk,Lucknow-226026, India
Lucknow
UTTAR PRADESH
226026
India 
Phone  9897118546  
Fax  -  
Email  dr.shivam.pt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Surya Kant 
Designation  Professor and Head, Respiratory Medicine, KGMU, Lucknow 
Affiliation  King Georges Medical University, UP, Lucknow 
Address  Dr. Surya Kant, Professor and Head, Department of Respiratory Medicine, King Georges Medical University, UP, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415016858  
Fax  -  
Email  skantpulmed@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Surya Kant 
Designation  Professor and Head, Respiratory Medicine, KGMU, Lucknow 
Affiliation  King Georges Medical University, UP, Lucknow 
Address  Dr. Surya Kant, Professor and Head, Department of Respiratory Medicine, King Georges Medical University, UP, Lucknow

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415016858  
Fax  -  
Email  skantpulmed@gmail.com  
 
Source of Monetary or Material Support  
King Georges Medical University, UP, Lucknow, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003, Republic of India 
 
Primary Sponsor  
Name  Shivam Srivastava 
Address  PhD Scholar and Cardio Pulmonary Physiotherapist, Department of Respiratory Medicine, King Georges Medical University, UP, Lucknow, Shah Mina Road, Chowk, Lucknow, Uttar Pradesh 226003. Republic of India 
Type of Sponsor  Other [Shivam Srivastava] 
 
Details of Secondary Sponsor  
Name  Address 
Cipla Foundation  Cipla Foundation, Mumbai 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Surya Kant  King Georges Medical University, UP, Lucknow  Pulmonary Rehabilitation Center, Department of Respiratory Medicine, King Georges Medical University, UP, Lucknow
Lucknow
UTTAR PRADESH 
09415016858
-
skantpulmed@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University, UP, Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, (2) ICD-10 Condition: J410||Simple chronic bronchitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pulmonary Rehabilitation Exercises  Pulmonary Rehabilitation Exercises included Pursed Lip breathing, Upper limb & Lower limb strength traing for 45 minutes twice a week for 8 weeks protocol 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  (1)Patients above the age of 30 to 80 years of all gender categories.
(2)Patient diagnosed with Chronic Obstructive Pulmonary Disease
(3)Patient having persisting symptoms of dyspnea and fatigue after an acute respiratory condition visited the OPD of Kasturba Chest Hospital, Department of Respiratory Medicine, King George’s Medical University, U.P., Lucknow
(4)Patient stable Vitals including BP, HR, SpO2 level
(5)Patient who give consent to exercise.
(6)Patient who give consent for offline & online session.
 
 
ExclusionCriteria 
Details  (1)Patient in IPD including HDU & ICU.
(2)Patient in Emergency
(3)Patient with various medical conditions where it would aggravate their present condition and/or be not feasible to participate in PRP. It would therefore not be safe or advisable for them to attempt such a programme. These would include: -Patients with signs of unstable cardiovascular parameters such as unstable angina, cardiac arrhythmias, uncontrolled hypertension, thromboembolic phenomenon
(4) Patients with psychotic disturbances or cognitive impairment 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To improve exercise capasity of chronic Obstructive Pulmonary Disease patient  8-weeks protocol with 2 sessions per week  
 
Secondary Outcome  
Outcome  TimePoints 
1- To control symptoms of Chronic Obstructive Pulmonary Disease patients (Measured by mMRC Grading of dyspnea as per Medical Research Council guideline)
2- To improve mental status of the COPD patient (measured by DASS 21: depression, Anxiety, Stress Scale 21)
3- To improve health related quality of life (HRQoL) of Chronic Obstructive Pulmonary Disease patients (Health Questionnaire: Quality of life will be assessed based on Euro QOL: EQ-5D-5L questionnaire).
4- To improve the nutritional status of COPD patients (MUST Score: Malnutrition Universal Screening Tool)
5- To increase compliance of patients for Pulmonary Rehabilitation Program (PRP) at Pulmonary Rehabilitation Centre (PRC), Department of Respiratory Medicine, King George’s Medical University, U.P., Lucknow
 
8-weeks protocol with 2 sessions per week 
 
Target Sample Size   Total Sample Size="161"
Sample Size from India="161" 
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)   17/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/02/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Executive Summary
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, characterized by persistent airflow limitation and progressive respiratory dysfunction. COPD often results in reduced quality of life, functional impairment, and increased healthcare utilization, presenting a significant burden on both patients and healthcare systems. Pulmonary rehabilitation (PR) has emerged as a multidisciplinary intervention aimed at improving the physical and emotional well-being of patients with chronic respiratory conditions, including COPD. It typically involves exercise training, education, and behavioral changes designed to enhance pulmonary function, increase exercise tolerance, and improve overall health outcomes.

Despite the growing evidence supporting the benefits of Pulmonary Rehabilitation, its effectiveness in improving long-term outcomes remains an area of ongoing debate. Previous studies have largely focused on short-term improvements, but there is a need for more comprehensive, long-term evaluations that assess the sustained impact of pulmonary rehabilitation on individuals with COPD. This research proposal aims to conduct an analytical prospective follow-up study to evaluate the impact of pulmonary rehabilitation on patients with COPD, with a focus on clinical outcomes, quality of life, and healthcare utilization over an extended period.

Through this study, we seek to fill existing gaps in the literature by assessing both the short- and long-term effects of pulmonary rehabilitation in COPD patients. The results of this research will provide valuable insights into the role of Pulmonary Rehabilitation as a key therapeutic intervention for managing COPD, informing clinical practice and policy decisions.


 
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