| CTRI Number |
CTRI/2025/07/091448 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Stacked Breathing vs Conventional Chest Physiotherapy on Lung Function in COPD Patients |
|
Scientific Title of Study
|
EFFECTIVENESS OF STACKED BREATHING VERSUS
CONVENTIONAL CHEST PHYSIOTHERAPY ON PULMONARY FUNCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) - AN EXPERIMENTAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yash Bhandari |
| Designation |
PG Scholar |
| Affiliation |
Drs. Kiran & Pallavi Patel Global University |
| Address |
Krishna School of Physiotherapy & Rehabilitation, Krishna Edu Campus, Varnama, Vadodara – 391240
Krishna School of Physiotherapy & Rehabilitation, Krishna Edu Campus, Varnama, Vadodara – 391240
Vadodara
GUJARAT
391240
India |
| Phone |
6359063338 |
| Fax |
|
| Email |
yashbhandari0007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Yash Bhandari |
| Designation |
PG Scholar |
| Affiliation |
Krishna School of Physiotherapy & Rehabilitation, KPGU |
| Address |
Krishna School of Physiotherapy & Rehabilitation, Krishna Edu Campus, Varnama
Cardiorespiratory lab Physiotherapy Department, 2nd floor
Vadodara
GUJARAT
391240
India |
| Phone |
6359063338 |
| Fax |
|
| Email |
yashbhandari0007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yash Bhandari |
| Designation |
PG Scholar |
| Affiliation |
Drs. Kiran & Pallavi Patel Global University |
| Address |
Krishna School of Physiotherapy & Rehabilitation, Krishna Edu Campus, Varnama, Vadodara – 391240
Krishna School of Physiotherapy & Rehabilitation, Krishna Edu Campus, Varnama, Vadodara – 391240
Vadodara
GUJARAT
391240
India |
| Phone |
6359063338 |
| Fax |
|
| Email |
yashbhandari0007@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Yash Bhandari |
| Address |
41 2 Ajran falia Kachigam Nani Daman Daman |
| 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 |
| Yash Bhandari |
Pranayam Lung and Heart Institute |
Department of Physiotherapy Pranayam Lung and Heart Institute New VIP Road Vadodara 390019
Vadodara
GUJARAT |
6359063338
yashbhandari0007@gmai.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Biomedical and Health 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 |
Conventional Chest Physiotherapy |
Patients will receive Diaphragmatic Breathing Exercise and Active Cycle of Breathing Technique (ACBT) without stacked breathing. Therapy will be provided twice daily, 4 days/week for 3 weeks. Outcomes measured will include PFT and CAT score. |
| Intervention |
Stacked Breathing Exercise with Conventional Chest Physiotherapy |
Patients will receive Diaphragmatic Breathing Exercise, Active Cycle of Breathing Technique (ACBT), and Stacked Breathing Exercise. Stacked breathing will be done in a sitting position, 5 repetitions per session, twice daily, 4 days/week for 3 weeks. Pulmonary Function Test and CAT score will be measured before and after intervention. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD) based on GOLD classification
Both male and female participants aged between 40 and 70 years |
|
| ExclusionCriteria |
| Details |
Patients with any other cardiorespiratory conditions
Patients with neuromuscular disorders
Presence of tumors
Acute exacerbation of COPD
Recent thoracoabdominal surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Forced Expiratory Volume in one second
2 Peak Expiratory Flow Rate |
Baseline and after 3 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/08/2025 |
| 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="0"
Months="0"
Days="21" |
|
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 experimental study aims to compare the effectiveness of Stacked Breathing Exercise versus Conventional Chest Physiotherapy on pulmonary function in patients with Chronic Obstructive Pulmonary Disease (COPD). A total of 30 patients aged 40 to 70 years, diagnosed with COPD, will be recruited and randomly allocated into two groups. Group A will receive Stacked Breathing Exercise along with Conventional Chest Physiotherapy, and Group B will receive only Conventional Chest Physiotherapy. Both groups will be treated for 3 weeks, 4 days per week, with outcome measures including Pulmonary Function Test (FEV1 and PEFR) and COPD Assessment Test (CAT) Score. The intervention aims to improve lung function and quality of life in COPD patients
|