| CTRI Number |
CTRI/2025/08/092952 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving breathing and daily activity levels through a Pulmonary Wellness Programme for people with COPD in a hospital in Chitradurga, Karnataka |
|
Scientific Title of Study
|
Effectiveness of Pulmonary Wellness Programme on STEP-Q among patients with COPD admitted in a Tertiary Care Hospital, Chitradurga, Karnataka. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Halaswamy KMG |
| Designation |
Professor |
| Affiliation |
SJM Institute of Nursing Sciences Chitradurga |
| Address |
Professor, and Head of the Department, Deaprtment of Medical Surgical Nursing, SJM Institute of Nursing Sciences Basaveshwara Medical College and Hospital Campus NH 04 Bypass Near KHB Colony Chitradurga Karnataka
Professor, and Head of the Department, Deaprtment of Medical Surgical Nursing, SJM Institute of Nursing Sciences Basaveshwara Medical College and Hospital Campus NH 04 Bypass Near KHB Colony Chitradurga Karnataka
Chitradurga
KARNATAKA
577501
India |
| Phone |
8147615161 |
| Fax |
|
| Email |
halaswamykmg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumathy P |
| Designation |
Professor |
| Affiliation |
Kasturba Gandhi Nursing College |
| Address |
Professor, Head of the Depaerment, Child Health Nursing, Kasthurba gandhi nursing college, Sri Balaji Vidyapeeth Campus, Cuddalore Main Road beside Mahatma Gandhi Medical College, Pillaiyarkuppam Pondicherry
Professor, Head of the Depaerment, Child Health Nursing, Kasthurba gandhi nursing college, Sri Balaji Vidyapeeth Campus, Cuddalore Main Road beside Mahatma Gandhi Medical College, Pillaiyarkuppam Pondicherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9944759280 |
| Fax |
|
| Email |
sumathyp@kgnc.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Halaswamy KMG |
| Designation |
Professor |
| Affiliation |
SJM Institute of Nursing Sciences Chitradurga |
| Address |
Professor, Head of the department, Department of Medical-Surgical Nursing, SJM Institute of Nursing Sciences Basaveshwara Medical College and Hospital Campus NH 04 Bypass Near KHB Colony Chitradurga Karnataka
Professor, Head of the department, Department of Medical-Surgical Nursing, SJM Institute of Nursing Sciences Basaveshwara Medical College and Hospital Campus NH 04 Bypass Near KHB Colony Chitradurga Karnataka
Chitradurga
KARNATAKA
577501
India |
| Phone |
8147615161 |
| Fax |
|
| Email |
halaswamykmg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Basaveshwara Medical College and Hospital, NH 04 bypass, Kelagote, Near KHB colony Chitradurg, Karnataka 577501 |
| Sri Balaji Vidyapeeth Cuddalore Main Road, Mahatma Gandhi Medical College Campus, Pillaiyarkuppam, Pondicherry-607403 |
|
|
Primary Sponsor
|
| Name |
Halaswamy KMG |
| Address |
Professor
SJM institute of nursing sciences, NH 04 bypass, KHB colony Chitradurga Karnataka 577501 |
| 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 |
| Halaswamy KMG |
Basaveshwara Medical College and Hospital |
General Ward, 2nd Floor, Ward No. 10A and 10B, Department of respiratory medicine
Chitradurga
KARNATAKA |
8147615161
halaswamykmg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Basaveshwara Medical College and Hospital Institutional Ethics Review Committee |
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 |
Chair Calisthenics |
once in a day on three alternate days per week (Evening) |
| Intervention |
Chair Yoga |
once in a day on three alternate days per week (Morning) |
| Comparator Agent |
Control Group |
Routine treatment |
| Intervention |
Stacked Breathing Exercises |
once in a day on three alternate days per week (Morning) |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Exclusion criteria
Patients with respiratory and psychological co-morbidities
Patients with locomotors disability
Patients with unstable angina, recent myocardial infarction, Congestive cardiac failure, cancer, orthopedic and lung diseases that could impair physical activities in daily life.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Study will help to improve Daily Step Count, Exercise capacity, Respiratory rate, Heart Rate, Oxygen saturation and health related quality of life among COPD patients |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The research is expected to evaluate the Effect of pulmonary wellness programme on Daily Step Count, Exercise capacity, Physiological parameters and Health related Quality of Life among patients with COPD.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/09/2025 |
| 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="1"
Months="2"
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
|
A review study showed that the prevalence of COPD among the population aged 30 years and above in India was 7%. Risk factors like active and passive smoking, biomass fuel exposure, environmental tobacco smoke, occupational exposure to dust, indoor and outdoor pollution, and increasing age were reported to have a significant association with COPD among the Indian population |