| CTRI Number |
CTRI/2024/10/075841 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| 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
|
This is a study to check the effect of intercostal stretch on breathing pattern and pulmonary functions and urge to smoke among male smokers |
|
Scientific Title of Study
|
Effect of intercostal stretch on breathing pattern, pulmonary functions and urge to smoke among male 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 |
Dr Minaxi PT |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana. |
| Address |
Room no. 66, Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana.
Panchkula
HARYANA
134107
India |
| Phone |
9041095121 |
| Fax |
|
| Email |
xs4minaxi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Minaxi PT |
| Designation |
Assistant Professor |
| Affiliation |
Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana. |
| Address |
Room no. 66, Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana.
HARYANA
134107
India |
| Phone |
9041095121 |
| Fax |
|
| Email |
xs4minaxi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonika |
| Designation |
MPT Student |
| Affiliation |
Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana. |
| Address |
Room no.66, Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana
Panchkula
HARYANA
134107
India |
| Phone |
8307273851 |
| Fax |
|
| Email |
drsonika1789@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saket college of physiotherapy, chandimandir, panchkula |
| Saket college of physiotherapy, chandimandir, panchkula |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 Sonika |
Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana. |
Room no.66, Physiotherapy department. Saket College of Physiotherapy, Chandimandir, Panchkula, Haryana.
Panchkula
HARYANA |
08307273851
drsonika1789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male smokers |
| Patients |
(1) ICD-10 Condition: T652||Toxic effect of tobacco and nicotine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Deep breathing |
Participant will be asked to do deep breathing, index finger will be placed to the intercostal space to provide cutaneous input. Total duration of treatment will be 20 minutes. The duration will be 3 days a week for 2 weeks. |
| Intervention |
Intercostal stretch |
Treatment protocol include( intercostal stretch on third intercostal space with the help of index finger for 10 breaths during inspiratory phase. There will be 3 sets of intercostal stretch with the gap of 3 minutes. Total duration of treatment will be 20 minutes per day in 3 days a week for 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
1.History of smoking of two years minimally14 Number of cigarettes smoking per day should be
2. Fagerstrom Test for Nicotine
Dependency (FTND) ≤7 |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Breathing pattern
2. FVC, FEV1
3. Urge to smoke |
outcomes will be assessed after 2 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
10/11/2024 |
| 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="0"
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
|
Effect of intercostal stretch on breathing pattern, pulmonary functions and urge to smoke among male smokers. This study investigates the effect of intercostal stretch on breathing pattern, pulmonary functions and urge to smoke among male smokers. The objective of the study is to evaluate the effect of intercostal stretch on breathing pattern using Hi-Lo mechanism. To evaluate the effect of intercostal stretch on pulmonary functions among male smokers using spirometer (RMS Helios401, India). To evaluate the effect of intercostal stretch on urge to smoke among male smokers using brief questionnaire of smoking urges (BQSU). Experimental study in which patient will undergo three sessions of intercostal stretch per week for two weeks. Breathing pattern, pulmonary functions (FVC and FEV1), and urge to smoke will be measured before and after intervention that is after two weeks. The findings of this study could provide a simple and inexpensive method to improve pulmonary functions, to improve breathing pattern and can also help to reduce urge to smoke among male smokers. |