| CTRI Number |
CTRI/2024/09/074141 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Smoking Cessation and Pulmonary Rehabilitation in Smokers with Spirometry Changes |
Scientific Title of Study
Modification(s)
|
Value of Early Intervention in Smokers with Preserved Ratio Impaired Spirometry(without comorbidities) with Pulmonary Rehabilitation and Smoking Cessation |
| 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 Arunan P |
| Designation |
Post Graduate MD Respiratory Medicine |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
A BLOCK,Department of Respiratory Medicine,Chettinad Hospital and Research institute,Kelambakkam
Chennai
Tamilnadu
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7094922653 |
| Fax |
|
| Email |
arunanarunan7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi |
| Designation |
Prof and HOD |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
Department of Respiratory Medicine ,Chettinad Hospital and Research Institute,
Kelambakkam , Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9677086029 |
| Fax |
|
| Email |
respiratorymedicine@care.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunan P |
| Designation |
Post Graduate MD Respiratory Medicine |
| Affiliation |
Chettinad Hospital and Research Institute |
| Address |
A block
Department of Respiratory Medicine, Chettinad Hospital and Research Institute,
Kelambakkam ,Chennai
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7094922653 |
| Fax |
|
| Email |
arunanarunan7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education,Kelambakkam-603103,TamilNadu,India |
|
|
Primary Sponsor
|
| Name |
Chettinad Academy of Research and Education |
| Address |
Chettinad Academy of Research and Education,Kelambakkam,Chengalpattu-603103 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Arunan |
Chettinad Hospital and Research Institute |
A block
Department of Respiratory Medicine (OPD no.9)
CHETTINAD HEALTH CITY
KELAMBAKKAM
Chennai
TAMIL NADU |
04447478241
arunanarunan7@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITEE FOR STUDENT RESEARCH (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pulmonary rehabilitation with smoking cessation |
Pulmonary rehabilitation with smoking cessation for 12 months after diagnosis of PRIsm in COPD patients |
| Comparator Agent |
Standard care for COPD with counselling on smoking cessation |
Standard care for COPD with counselling on smoking cessation for 12 months after diagnosis of PRIsm in COPD patients |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Both Male and Female
Patients who have access to smart phones with internet
Patients who are smokers with COPD
Patients who have abnormality in spirometry such as PRIsm |
|
| ExclusionCriteria |
| Details |
Patients who are less than 25 years
Patients who dont have respiratory symptoms
Patients with normal spirometry
Patients who dont have Chest X ray abnormalities |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify smokers with PRIsm using spirometry to assess disease severity using MMRC grading,CAT score and spirometric classification of COPD and smoking index |
Baseline and at 2nd month,4th month,6th month,8th month,10th month and 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To intervene with smoking cessation and pulmonary rehabilitation to improve the quality of life and also treat another group with placebo and counselling to improve the quality of life |
Frequent followup of patients upto 12 months |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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)
|
03/10/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The term PRIsm is characterized by decreased forced expiratory volume in one second (FEV1<80%) without airflow limitation (FEV1/FVC >0.7) The risk of COPD was increased in PRIsm patients. Several studies shows association between PRIsm and Smokers. We divide the smokers into three groups based on spirometry results: normal, PRIsm, and COPD. Study design is based on Randomized control study. The reason for taking this study is COPD is said to be irreversible condition. My plan is to identify smokers with PRIsm and grade them in early COPD criteria and reverse the condition of one group by pulmonary rehabilitation and smoking cessation and other group by placebo and counselling. Pulmonary rehabilitation is the most effective intervention for improving the quality of life and decreasing morbidity and mortality and its also cost effective tool. Smoking cessation also improves the quality of life by decreasing morbidity and mortality and also one of the effective intervention.The study is randomized controlled parallel trial arms to determine smoking cessation and pulmonary rehab in parallel part whereas placebo and counselling in control part. Total of 142 patients will be randomized into two groups using computer generated randomization that control group(n=71) and parallel group which will consist of smoking cessation and pulmonary rehab(n=71) and assesor outcome will be blinded to group allocation. Intervention group will receive pulmonary rehab including breathing exercises,upper limb exercises,lower exercises and mixed exercises and also they will receive validated education booklet , videos and dairy to note daily exercises. Whereas control group will receive placebo and counselling.Outcome will be assesed at baseline,2nd month,4th month,6th month,8th month,10th month and 12th month(end of intervention) |