| CTRI Number |
CTRI/2025/02/081322 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| 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
|
Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Diseases in a Tertiary Care Center in North India |
|
Scientific Title of Study
|
To study the effect of Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease patients in a Tertiary Care Center of North India A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anurag Basu |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences Banaras Hindu university Department of TB and Respiratory Diseases |
| Address |
Department of TB and Respiratory Diseases, Sir Sunderlal Hospital Banaras Hindu university
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9007223970 |
| Fax |
|
| Email |
anu.basu2015@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Basu |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University Department of TB and Respiratory Diseases |
| Address |
Department of TB and Respiratory Diseases, Sir Sunderlal Hospital, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9453512821 |
| Fax |
|
| Email |
anu.basu2015@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Bhatia |
| Designation |
Associate Professor Department of TB and Respiratory Diseases |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University Department of TB and Respiratory Diseases |
| Address |
Department of TB and Respiratory Medicine, Sir Sunderlal Hospital, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9453512821 |
| Fax |
|
| Email |
Mohitbhatia@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Department of TB and Respiratory Medicine, Varanasi,Uttar Pradesh,India,PIN 221005 |
|
|
Primary Sponsor
|
| Name |
Anurag Basu |
| Address |
Department of TB and Respiratory Diseases Sir Sunderlal Hospital Banaras Hindu University, Varanasi, Uttar Pradesh, India PIN 221005 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Mohit Bhatia |
Sir Sunderlal Hospital, Banaras Hindu University |
Department of Respiratory Diseases Banaras Hindu University campus
Varanasi
UTTAR PRADESH |
9453512821
mohitbhatia@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University |
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 |
| Comparator Agent |
Pharmacological treatment |
Change in 6 min walk test, spirometry, St Georges respiratory questionnaire, MMRC dyspnea scale, treadmill and bicycle ergometry and psychiatric DAS assessment score, CRP with only conventional pharmacological treatment. |
| Intervention |
Pharmacological treatment, Pulmonary rehabilitation(exercise training) |
Change in 6 min walk test, spirometry, St Georges respiratory questionnaire, MMRC dyspnea scale, treadmill and bicycle ergometry and psychiatric DAS assessment score, CRP and evaluate whether pulmonary rehabilitation added with conventional pharmacological therapy changes the morbidity and prolong the life expectancy of individuals |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
COPD patients as per GOLD guidelines
|
|
| ExclusionCriteria |
| Details |
Angina pectoris, recent myocardial infarction, severe pulmonary hypertension.
Congestive heart failure.
Patient with acute pulmonary diseases.
Inability to do exercise due to orthopedic or other reasons.
Severe exercise-induced hypoxemia, not correctable with O2 supplementation.
Severe Psychiatric illness, dementia, unable to understand and follow instructions.
Lack of motivation, non-adherence, unwilling to give consent.
Hemodynamically unstable patients.
All other chronic respiratory disease including interstitial lung disease, Bronchial asthma and bronchiectasis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in cases and control groups in the following parameters 6 min walk test, spirometry, St Georges respiratory questionnaire, MMRC dyspnea scale, treadmill and bicycle ergometry and psychiatric DAS assessment score, CRP and evaluate whether pulmonary rehabilitations changes the morbidity and prolong the life expectancy of individuals
|
6 weeks follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in St Georges respiratory questionnaire, MMRC dyspnea scale,psychiatric DAS assessment score, CRP change in case and control |
6 week follow up |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/03/2025 |
| 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="2"
Months="0"
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
|
Study design: To study the effect of Pulmonary rehabilitation in COPD in inpatients and outpatients in tertiary care centre of North India, a Randomized assessor blinded controlled trial study. Outcomes to be measured: Change in cases and control groups in the following parameters 6 min walk test, spirometry, St Georges respiratory questionnaire, MMRC dyspnea scale, treadmill and bicycle ergometry and psychiatric DAS assessment score, CRP and evaluate whether pulmonary rehabilitations changes the morbidity and prolong the life expectancy of individuals
|