| CTRI Number |
CTRI/2024/12/078513 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of ACBT and PLB on Lung Efficiency in Young Smokers |
|
Scientific Title of Study
|
Effectiveness of Active Cycle of Breathing Techniques and Pursed Lip Breathing on Lung Efficiency in Young Smokers |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raveena |
| Designation |
PG student |
| Affiliation |
Amity Institute of Health Allied Science |
| Address |
Amity Institute of Health Allied Sciences, room no. 1 Physiotherapy Department, Sector 125 Noida Uttar Pradesh
Amity Institute of Health Allied Science, Physiotherapy Department Sector 125 Noida 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9069755075 |
| Fax |
|
| Email |
raveena.lodhi028@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Gupta |
| Designation |
Associate Professor |
| Affiliation |
Amity Institute of Health Allied Science |
| Address |
Amity Institute of Health Allied Science, room no. 1 Physiotherapy Department, Sector 125, Noida India 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9717281491 |
| Fax |
|
| Email |
mgupta9@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ritika Kumar |
| Designation |
Teaching Associate |
| Affiliation |
Amity Institute of Health Allied Science |
| Address |
Amity Institute of Health Allied Science, room no. 1 Physiotherapy Department, Sector 125, Noida India 201301
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9810307668 |
| Fax |
|
| Email |
rkumar21@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Sciences, Amity University Noida Uttar Pradesh
Sector 125, Noida, Uttar Pradesh India 201301 |
|
|
Primary Sponsor
|
| Name |
Raveena Lodhi |
| Address |
Room no. 1
Amity Institute of Health Allied Sciences, Amity University Noida Uttar Pradesh
Sector 125, Noida, Uttar Pradesh, India 201301 |
| 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 |
| Dr Meena Mam |
Amity Insitute of Health Allied Science |
Amity Institute of Health Allied Science Sector 125 Noida 201301
Amity OPD Room no 1
gate no 1
Gautam Buddha Nagar
UTTAR PRADESH |
09717281491
mgupta9@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee, Amity Institute of Health Allied Science, Amity University, Noida, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
smokers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active Cycle of Breathing Techniques
Pursed Lip Breathing |
ACBT- To Improve airway clearance and enhance lung function by using a series of controlled breathing exercises.
5 cycles 3 times per week for 4 weeks
Pursed Lip Breathing- to enhance lung efficiency, promote ventilation and reduce shortness of breath by prolonging exhalation and keeping the airways open longer.
5 breaths cycle 3 times a week for 4 weeks |
| Comparator Agent |
Peak Expiratory flow Meter |
The device measures how well the air flows out of the lungs.
3 readings for 1 best reading |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Aged between 20-30 years, irrespective of gender.
2. History of smoking (more than 3 years)
3. No history of pulmonary conditions
4. Willing to participate
5. Equal to or more than 10 |
|
| ExclusionCriteria |
| Details |
1. Any comorbidities
2. Any malignancy, liver, or renal impairment.
3. Any mental or Psychological disorder
4. Any Cardiopulmonary surgical history
4. Regular gym Going person
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Peak Expiratory Flow rate
|
Baseline assessment before intervention
follow up assessement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Chest Expansion |
Baseline assessment before intervention
follow up assessement |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
10/01/2025 |
| 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="28" |
|
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
|
Patients
with a history of Smoking sooner or later develop respiratory symptoms,
wheezing, cough with sputum, chest tightness, and reduced tidal breathing(8).
Previous studies show that ACBT effectively clears bronchial secretion and
improves lung function. Pursed Lip Breathing exercises reduce breathlessness
and improve quality of life. This brings the need to check the effectiveness of
the active cycle of breathing technique and pursed lip breathing on lung
efficiency in young chronic male and female smokers. |