| CTRI Number |
CTRI/2024/02/062562 [Registered on: 13/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
To study the outcomes of Pulmonary Rehabilitation in patients of Chronic Obstructive Pulmonary Disease |
|
Scientific Title of Study
|
OUTCOMES OF PULMONARY REHABILITATION IN PATIENTS OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE IRRESPECTIVE OF DISEASE BURDEN |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARMAN SINDHU |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Datta Meghe Institute of Higher Research and Education , SAWANGI, WARDHA, MAHARASHTRA |
| Address |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, SAWANGI MEGHE WARDHA MAHARASHTRA 442107
Wardha
MAHARASHTRA
442001
India |
| Phone |
7404166631 |
| Fax |
|
| Email |
armansindhu1198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ULHAS JADHAV |
| Designation |
PROFESSOR |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH , SAWANGI, WARDHA, MAHARASHTRA |
| Address |
DEPARTMENT OF RESPIRATORY MEDICINE
JAWAHARLAL NEHRU MEDICAL COLLEGE
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH SAWANGI MEGHE WARDHA MAHARASHTRA 442107
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970819099 |
| Fax |
|
| Email |
Drulhasjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ARMAN SINDHU |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH, SAWANGI, WARDHA, MAHARASHTRA |
| Address |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH SAWANGI MEGHE WARDHA MAHARASHTRA 442107
MAHARASHTRA
442001
India |
| Phone |
7404166631 |
| Fax |
|
| Email |
armansindhu1198@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACHARYA VINOBA BHAVE RURAL HOSPITAL, SAWANGI (MEGHE), WARDHA, MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
SAWANGI MEGHE WARDHA MAHARASHTRA 442107 |
| Type of Sponsor |
Private medical college |
|
|
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 ARMAN SINDHU |
Acharya Vinoba Bhave Rural Hospital Sawangi (meghe), Wardha |
DEPARTMENT OF RESPIRATORY MEDICINE
JAWAHARLAL NEHRU MEDICAL COLLEGE, Sawangi (meghe), Wardha
Wardha
MAHARASHTRA |
7404166631
armansindhu1198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
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 |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
PULMONARY REHABILITATION WITH SYSTEMIC TREATMENT |
PATIENTS WILL BE GIVEN PULMONARY REHABILITATION UNDER SUPERVISION ONCE A WEEK FOR 8 WEEKS, THEN FORTNIGHTLY FOR THE NEXT 2 MONTHS AND WILL BE FOLLOWED UP UPTO 6 MONTHS
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults diagnosed with COPD despite disease severity. |
|
| ExclusionCriteria |
| Details |
Active TB/Infective respiratory illness, Any serious co-morbidity requiring treatment on priority, Unstable cardiovascular/neurological diseases,Patients who were mechanically ventilated in the last 6 weeks, Patients developing any complication during the research period (eg. Pneumothorax, haemoptysis), Non-compliant patients,
Non-consenting patients, Patients contraindicated to perform PFT.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will aid us in evaluating if pulmonary rehabilitation helps in improving the quality of life, helps in improving the disability and reduces the exacerbation. |
We will assess the subjects at 2 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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) |
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
|
This study will aid us in evaluating if Pulmonary Rehabilitation along with pharmacological therapy helps in decreasing dosage of bronchodilator drugs and also helps reducing the exacerbations of COPD and overall chest muscle strengthening. |