| CTRI Number |
CTRI/2026/02/103704 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [back massage] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the Effectiveness of Nurse-Led Intervention on Clinical Parameters and Quality of Life in Chronic Obstructive Pulmonary Disease Patients of Sharda Hospital, Greater Noida. |
|
Scientific Title of Study
|
Effectiveness of Nurse-Led Intervention on Clinical Parameters and Quality of Life in Chronic Obstructive Pulmonary Disease Patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Pandey |
| Designation |
PhD Scholar |
| Affiliation |
Sharda University |
| Address |
flat no: 305, Royal Residency, kishan garh, vasant kunj.
DELHI
110070
India |
| Phone |
9899988432 |
| Fax |
|
| Email |
2024279442.pooja@dr.sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Pooja Pandey |
| Designation |
PhD Scholar |
| Affiliation |
Sharda University |
| Address |
flat no 305, Royal Residency, Kishan Garh, Vasant Kunj.
DELHI
110070
India |
| Phone |
9899988432 |
| Fax |
|
| Email |
2024279442.pooja@dr.sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitika Thakur |
| Designation |
Professor |
| Affiliation |
Sharda University |
| Address |
H-1015, AVJ Hights, Greater Noida.
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9459837638 |
| Fax |
|
| Email |
nitika.thakur@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Pooja Pandey |
| Address |
Sharda University, Greater Noida |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pooja Pandey |
Sharda Hospital |
Sharda Hospital, Greater Noida.
New Delhi
DELHI |
9899988432
2024279442.pooja@dr.sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School of Medical Sciences & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J989||Respiratory disorder, unspecified, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nurse-Led Intervention |
Im providing a Back massage and Pursed-Lip breathing exercise. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
76.00 Year(s) |
| Gender |
Both |
| Details |
Male and female
those willing to participate
Hemodynamically stable patients
Patients come under GOLD Classification 1,2 & 3 |
|
| ExclusionCriteria |
| Details |
with severe dyspnea
mentally ill patient
patients with no attendant
COPD patients who have participated in any pulmonary rehabilitation program |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Heart rate, respiratory rate and oxygen saturation. |
day 0, day 5, day 30, day 90, day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in breath-hold time, six-minute walk test and CAT score. |
day 0, day 5, day 30, day 90, day 180 |
| changes in mmRc dyspnea score and FEV1, FVC and PEFR. |
day 0, day 5, day 30, day 90, day 180. |
| improvement in Quality of life |
day 30, day 90, day 180 |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="104"
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)
|
23/02/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This Randomized control trial aims to evaluate the effectiveness of nurse-led intervention on clinical parameters and Quality of life in patients with Chronic obstructive pulmonary disease. The intervention includes a Back massage and Pursed-lip breathing exercise. The control group will receive only pursed lip breathing exercise. The study will assess clinical parameters including FEV1, FCV and PEFR. Dyspnea level using modified medical research council scale, quality of life using WHOQOL-BREF scale. Respiratory rate, Heart rate , SPO2, breath hold test , 6 minute walk test will also be measured. data will be collected at baseline and after completion of intervention to determine the effectiveness of nurse-led intervention. |