| CTRI Number |
CTRI/2024/12/077930 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing changes in heart rate and oxygen levels after two different exercise tests in people with chronic lung disease |
|
Scientific Title of Study
|
Comparison of post exercise changes in Pulse rate and SpO2 after 2 chair test with 6 minute walk test in 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 |
Durgesh J Hirekar |
| Designation |
DM student |
| Affiliation |
VMMC and Safdarjung Hospital, |
| Address |
Room 638, Department of Pulmonary Medicine, Super speciality Block, VMMC and Safdarjung Hospital
Ansari Nagar East, Near AIIMS Metro Station
New Delhi
DELHI
110029
India |
| Phone |
9177798241 |
| Fax |
|
| Email |
hirekardurgesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitesh Gupta |
| Designation |
Associate Professor |
| Affiliation |
VMMC and SJH |
| Address |
Room 612, Department of Pulmonary medicine, Superspecialty block, VMMC and safdarjung hospital
Ansari Nagar East, near AIIMS metro station
South
DELHI
110029
India |
| Phone |
9873096364 |
| Fax |
|
| Email |
niteshgupta2107@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DURGESH J HIREKAR |
| Designation |
DM student |
| Affiliation |
VMMC and SJH |
| Address |
Room 638, Department of Pulmonary medicine, Superspecialty block, VMMC and safdarjung hospital
Ansari Nagar east, near AIIMS Metro station
South
DELHI
110029
India |
| Phone |
9177798241 |
| Fax |
|
| Email |
hirekardurgesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, Ansari Nagar East, Near AIIMS Metro station, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029 |
| Type of Sponsor |
Government 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 DURGESH J HIREKAR |
Vardhaman and Mahavir Medical College and Safdarjung Hospital |
Room 638, Superspecialty Block, VMMC and Safdarjung Hospital, Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029
South
DELHI |
9177798241
hirekardurgesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 40-75 years diagnosed with COPD as per GOLD 2023 guidelines
No acute exacerbation of COPD in the last 30 days before inclusion |
|
| ExclusionCriteria |
| Details |
1. Patients with history of acute myocardial infarction in the preceding 4 weeks or any cardiovascular instability on clinical assessment at the time of study
2. Patients with Left ventricular dysfunction
3. Patients with gross musculoskeletal problems such as knee osteoarthritis, or other neurological disorder that may impede normal movement ability
4. Patients on beta blockers or calcium channel blockers
5. Patients with severe anaemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post exercise pulse rate and SpO2 after Two chair test and Six minute walk test in patients with COPD. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare post exercise changes in PR SpO2 changes following 2 chair test with that of squat to stand test in COPD patients
To compare PR and SpO2 changes following 2 chair test and squat to stand test with FEV1 in COPD patients |
baseline |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/12/2024 |
| 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 Yet Recruiting |
| 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
|
A prospective observational study with the aim to study the correlation between 2 chair test and 6 minute walk test with respect to post exercise changes in PR and SpO2 in patients with Chronic obstructive pulmonary disease. A minimum number of 60 Adult patients of COPD aged 40-70 years attending the OPD or IPD of Department of Pulmonary medicine, VMMC and Safdarjung Hospital will be included. Secondary objectives include comparing post exercise changes in PR and SpO2 following 2 chair test with that of Squat to stand test in COPD and comparing PR, SpO2 changes following 2 chair test and squat to stand test with FEV1 in COPD patients. |