FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/068138 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Breathing and chest exercises for young smokers lung health 
Scientific Title of Study   Impact of breathing exercises and chest mobility exercises on pulmonary function and exercise tolerance 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  Nisha jaiswal 
Designation  UG Student 
Affiliation  School of Allied health Sciences Galgotias University 
Address  Galgotias University Plot No 2 Yamuna Expr opposite Buddha International Circuit Sector 17A, Gautam buddha Nagar Greater Noida, Uttar Pradesh
Plot No 2 Yamuna Expr opposite Buddha International Circuit Sector 17A, Gautam buddha Nagar Greater Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  8127917838  
Fax    
Email  Nisha.20SMAS1010006@galgotiasuniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Ambreen fatima 
Designation  Assistant professor 
Affiliation  Galgotias university 
Address  Room no.b-319 Galgotias University Plot No 2 Yamuna Expy opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9760084221  
Fax    
Email  ambreen.fatima@galgotiasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr. Ambreen fatima 
Designation  Assistant professor 
Affiliation  Galgotias university 
Address  Room no. B319 Galgotias University Plot No 2 Yamuna Expy opposite Buddha International Circuit Sector 17A Greater Noida Uttar Pradesh

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9760084221  
Fax    
Email  ambreen.fatima@galgotiasuniversity.edu.in  
 
Source of Monetary or Material Support  
Research and Development cell, Room No B-319, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar 
 
Primary Sponsor  
Name  Prof Dr Chandan Kumar 
Address  B-516, Block-B, Galgotias University Greater Noida Uttar Pradesh 203201 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ambreen fatima  Physiotherapy department OPD Galgotias university  Room No E-003, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No2, Sector 17A, Opposite Buddha International Circuit, Greater Noida Gautam Buddha Nagar UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH 		 9760084221

ambreen.fatima@galgotiasuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental research committee department of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Young smokers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Breathing exercises   Pursed lip breathing for 10 times. deep breathing for 5 time diaphragmatic breathing for 10 times. 
Intervention  Chest mobility exercises and breathing exercises  Chest mobility exercise- Rib torsion exercise , passive lateral flexion of thorax in supine lying, passive lateral flexion in side lying on pillow, Direct rib stretching ,trunk rotation and trunk side flexion in sitting position. these exercises will be done two times on each side with a rest of 15 sec in between for 10 min. Breathing exercises- pursed lip breathing diaphragmatic breathing and deep breathing Repeat these exercises for 5 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Smoking history of at least one year.
Smokers who have smoked at least 10 cigarettes per day for the
past year.
Smokers both male and female.
Smokers who do not have any respiratory illness or suffering from
any musculoskeletal and neurological disease. 
 
ExclusionCriteria 
Details  Participants with musculoskeletal, cardiovascular and neurological
disorders affecting exercise participation.
Pregnancy.
History of recent fracture in ribs or spine.
Pregnant individuals 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Spirometry forced expiratory volume in 1 second ,forced vital capacity , forced expiratory volume in 1 second by forced vital capacity
six minute walk test distance covered  		 Baseline,4th week and follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Chest wall expansion measurement of axilla & xiphisternum
 		 Baseline, 4th week , follow up 
 
Target Sample Size   Total Sample Size="89"
Sample Size from India="89" 
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 
Date of First Enrollment (India)   10/06/2024 
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="0"
Months="1"
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  

Introduction
Smoking is harmful because it damages the lungs  Deep breathing exercises can improve lung function by helping you breathe better These exercises include pursed-lip breathing and diaphragmatic breathing   Chest mobility exercises are also important for improving lung function and overall ventilation  

Methodology
Assess pulmonary function and exercise tolerance using spirometry measuring tape and functional tests for all participants  Divide participants into control and experimental groups based on inclusion criteria Supervise exercise execution  Aim to improve lung function and respiratory muscles Participants maintain usual activities Monitor lifestyle changes  Record baseline measurements age  BMI  height weight  Implement interventions for 4 weeks After intervention conduct post-intervention spirometry and record measurements for both groups
 
Close