| 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
|
|
|
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. |