| CTRI Number |
CTRI/2021/06/034279 [Registered on: 17/06/2021] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [PHYSIOTHERAPY INCLUDING SPECIFIC BREATHING TECHNIQUE] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness Of Alternate Nostrils Breathing And Slow Deep Breathing On Physical fitness, Pulmonary Function, Smoking Urges and Quality of life In Male Sedentary Smokers. |
|
Scientific Title of Study
|
A study to compare the effectiveness of alternate nostrils breathing and slow deep breathing on physical fitness, pulmonary function, smoking urges and quality of life in male sedentary smokers. |
| Trial Acronym |
ANB SDB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemang Jani |
| Designation |
Associate Professor |
| Affiliation |
Saurashtra University Rajkot |
| Address |
OPD Rearch Center, Ground floor, Harivandana Physiotherapy College, Near Saurashtra University Munjka main Road Rajkot
Near Munjka Village, University Road, Rajkot
Rajkot
GUJARAT
360005
India |
| Phone |
9033762190 |
| Fax |
|
| Email |
hemangkumarjani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HEMANG S JANI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Saurashtra University Rajkot Gujarat |
| Address |
OPD Rearch Center, Ground floor, Harivandana Physiotherapy College, Near Saurashtra University Munjka main Road Rajkot
Near Munjka Village, University Road, Rajkot
Rajkot
GUJARAT
360005
India |
| Phone |
9033762190 |
| Fax |
|
| Email |
hemangkumarjani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR HEMANG S JANI |
| Designation |
Associate Professor |
| Affiliation |
Saurashtra University Rajkot |
| Address |
OPD Rearch Center, Ground floor, Harivandana Physiotherapy College, Near Saurashtra University Munjka main Road Rajkot
Near Munjka Village University Road Rajkot
Rajkot
GUJARAT
360005
India |
| Phone |
9033762190 |
| Fax |
|
| Email |
hemangkumarjani@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ANI HEMANGKUMAR SUDHAKARBHAI |
| Address |
Near Munjka Main Road, Munjka Rajkot |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 HEMANG JANI |
HARIVANDANA PHYSIOTHERAPY COLLEGE |
OUTPATIENT RESEARCH DEPARTMENT GROUND FLOOR NEAR SAURASHTRA UNIVERSITY CAMPUS MUNJAKA MAIN ROAD MUNJAKA RAJKOT GUJARAT INDIA 360005
Rajkot
GUJARAT |
9033762190
hemangkumarjani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAFE SEARCH INDEPENDENT ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Male Sedentary Smokers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alternate Nostrils Breathing |
15 minutes every day for 4 weeks. |
| Comparator Agent |
Slow Deep Breathing |
15-min diaphragm respiration exercises everyday for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Male |
| Details |
1.Male subjects between the age group of 25-55 years.
2.Smokers who smoke a minimum of 1 cigarette/day for at least 10 years and still use cigarettes.
3.They must have a sedentary lifestyle as no leisure-time physical activity or activities done for less than 20 minutes or fewer than 3 times per week. |
|
| ExclusionCriteria |
| Details |
1.Incapable of realizing the protocol of respiratory exercises.
2.Difficulty in completing the evaluation of pulmonary function.
3.Any known pulmonary, cardiac pathologies, musculoskeletal disorders or recent surgery.
4.Diabetes mellitus, uncontrolled hypertension, activity restriction due to disease, significant arthritis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Physical fitness, Pulmonary Function, Smoking Urges and Quality of life. |
outcomes will be assessed at baseline and after 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
12 Min Walk Test,
(FVC) forced vital capacity forced expiratory volume in one second (FEV1), FEV1/FVC ratio.
RAND 36 –Item health survey 1.0 scales: eight dimensions of HRQoL.
Brief Questionnaire On Smoking Urges (QSU-Brief) |
0 DAY AND 28 DAY |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "300"
Final Enrollment numbers achieved (India)="300" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/06/2021 |
| Date of Study Completion (India) |
01/09/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
A Study To Compare The Effectiveness Of Alternate Nostrils Breathing And Slow Deep Breathing On Physical fitness, Pulmonary Function, Smoking Urges and Quality of life In Male Sedentary Smokers. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A Study To Compare The Effectiveness Of Alternate Nostrils Breathing And Slow Deep Breathing On Physical fitness, Pulmonary Function, Smoking Urges and Quality of life In Male Sedentary Smokers. |