| CTRI Number |
CTRI/2024/12/078238 [Registered on: 17/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Enhancing quality of life in COPD Patients: A comprehensive study of the impact of Pulmonary Strengthening Package(Incentive spirometry,Pursed lip breathing & Yoga Therapy) on Clinical outcomes. |
|
Scientific Title of Study
|
Effectiveness of Pulmonary strengthening package on Health-related Quality of Life and Clinical Outcomes among Chronic Obstructive Pulmonary Disease patients of Selected Hospitals at Moradabad. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JITENDRA SINGH |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer College of Nursing |
| Address |
Teerthanker Mahaveer College of Nursing, Department of Medical Surgical Nursing,Room Number 215, Moradabad.(UP)244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7976426526 |
| Fax |
|
| Email |
jitendras.nursing@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. S P Subashini |
| Designation |
Dean Nursing |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer University College of Nursing, Dean Office, Room Number 101, Moradabad. (UP)244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
6399000660 |
| Fax |
|
| Email |
subashiniphd2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
JITENDRA SINGH |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer College of Nursing |
| Address |
Teerthanker Mahaveer College of Nursing, Department of Medical Surgical Nursing,Room Number 215, Moradabad.(UP)244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7976426526 |
| Fax |
|
| Email |
jitendras.nursing@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer College of Nursing, Delhi road, Moradabad,UP India,244001 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Karan Jain |
Teerthanker Mahaveer University Hospital |
TB and chest department,Room Number 326, Delhi road, Moradabad (UP)244001
Moradabad
UTTAR PRADESH |
7755989555
dr.karanjain22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer University Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Incentive spirometry, pursed lip breathing exercise and Yoga Therapy |
1. Incentive spirometry: 8 to 10 min per day for 6 Month
2. pursed lip breathing exercise 8 to 10 min per day for 6 Month
3. yoga includes:
Anulomvilom: 8 to 10 min per day for 6 Month
Kapalbhati: 8 to 10 min per day for 6 Month
Bhramari: 4 to 5 min per day for 6 Month |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are
Willing to participate and available during the time of data collection.
Able to understand either English or Hindi
Admitted Adults more then 18 years of age patients Diagnosed with COPD as per medical records
Both male and female
|
|
| ExclusionCriteria |
| Details |
Patients who has
History of any co-morbid illness (Neurologic and psychiatric)
who have participated in any pulmonary rehabilitation program for the past 6 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| COPD Patients Pulmonary muscles strength will improve after interventions of Pulmonary strengthening package |
COPD Patients Pulmonary muscles strength will improve after interventions of Pulmonary strengthening package for 6 Months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pulmonary Muscles strengthening will be improved.
|
2 Month |
|
|
Target Sample Size
|
Total Sample Size="122"
Sample Size from India="122"
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)
|
30/12/2024 |
| 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
|
Purpose of Study: According
to the World Health Organization (WHO), chronic obstructive pulmonary disease
(COPD) was the third leading cause of mortality worldwide in 2019, causing 3.23
million deaths, over 80% of which occurred in low- and middle-income countries.
COPD is characterized by persistent, progressive respiratory symptoms,
including dyspnea, cough, and increased phlegm production. The primary
objective of breathing exercises is to alleviate these symptoms by
strengthening respiratory muscles. Previous studies have shown that techniques
such as pursed-lip breathing, incentive spirometry, yoga, and general
spirometry are effective in managing COPD. This study aims to further
investigate the effectiveness of these techniques in COPD management.
|