| CTRI Number |
CTRI/2026/03/106005 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
How the 4-7-8 Breathing Technique Affects Heart and Lung Function Right After Exercise in Young Adults |
|
Scientific Title of Study
|
Immediate Effect of 4-7-8 breathing technique after SubMaximal exercise on Cardiorespiratory Function in young adults: A Randomized Crossover Trial |
| 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 Siddhi Milind Waikar |
| Designation |
PG student |
| Affiliation |
TMVs Lokmnaya Tilak college of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third Floor Department of CVRS Physiotherapy Tilak Maharashtra Vidyapeeth J Block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9822485998 |
| Fax |
|
| Email |
siddhi.waikar0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayendra Rajguru |
| Designation |
Head of department and professor |
| Affiliation |
TMVs Lokmnaya Tilak college of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third Floor Department of CVRS Physiotherapy Tilak Maharashtra Vidyapeeth J Block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9769944908 |
| Fax |
|
| Email |
vijendrarajguru777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayendra Rajguru |
| Designation |
Head of department and professor |
| Affiliation |
TMVs Lokmnaya Tilak college of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third Floor Department of CVRS Physiotherapy Tilak Maharashtra Vidyapeeth J Block Sector 14 Near Raghunath Vihar Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9769944908 |
| Fax |
|
| Email |
vijendrarajguru777@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak college of Physiotherapy , kharghar 410210 ,navi mumbai, Maharashtra,india |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak college of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy Third Floor Department of Cardiovascular and respiratory Physiotherapy Tilak Maharashtra Vidyapeeth J Block Sector 14 Near Raghunath Vihar Kharghar 410201, Navi Mumbai , Maharashtra, India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak college of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, Block J, Raghunath Vihar, Sector 14, Kharghar- 410210 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Siddhi Milind Waikar |
TMVs Lokmanya Tilak College of Physiotherapy |
CVRS department of physiotherapy,3rd floor, Block J, Raghunath Vihar, Sector 14, Kharghar- 410210
Raigarh
MAHARASHTRA |
9822485998
siddhi.waikar0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
18-25 yr healthy adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
4 7 8 breathing exercises |
4 7 8 breathing technique
inhale through nose for 4 second and hold breath for 7 seconds then exhale slowly through pursed lips for 8 seconds
repeat this cycle for 4 to 8 times
purpose to promotes relaxation reduce stress improve sleep quality
benefites are maintain heart rate reduces sympathetic drive control breathing pattern helpful in hyperventilation and insomnia |
| Comparator Agent |
pre and post respiratory rate blood pressure oxygen saturation and heart rate recovery in 1 min 3 min and 5 min |
submaximal test will increase all the parameters so comparing these parameters pre and post recovery will provide data reagarding effectivness of 4 7 8 breathing technique |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Range:18–25 years
2. Both gender: male and female
3. Consent: Subject who voluntarily agree to participate and sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Medical Conditions: Diagnosed respiratory (e.g., asthma, COPD), cardiovascular (e.g., hypertension), or neuromuscular disorders. Any chronic illness or condition affecting functional capacity.
2. Medication Use: Regular use of medications that could influence respiratory function or physical performance (e.g., bronchodilators, beta-blockers).
3. Physical Limitations: Any musculoskeletal injuries or conditions that limit physical activity (e.g., inability to perform the Harvard Step Test).
4. Pregnancy: Pregnant or breastfeeding individuals, due to physiological changes that could affect the study outcomes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Respiratory rate
blood pressure
oxygen saturation
rate of perceived exertion
resting heart rate
heart rate recovery |
1min , 3 min , 5 min pre and post
2 days of washout period for crossover |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/03/2026 |
| 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="6"
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
|
Objective To evaluate the immediate effect of the 4 7 8 breathing technique on cardiorespiratory function following submaximal exercise in healthy young adults aged 18 to 25 years Inclusion Criteria Healthy males and females aged 18 to 25 years who voluntarily agree to participate and provide informed consent Exclusion Criteria Individuals with diagnosed cardiovascular respiratory or neuromuscular disorders those on medications affecting cardiorespiratory function participants with musculoskeletal limitations restricting exercise performance and pregnant or breastfeeding individuals Outcome Measures Heart rate recovery blood pressure respiratory rate oxygen saturation and rate of perceived exertion Procedure Participants will perform a modified Harvard Step Test as a submaximal exercise protocol followed by either passive recovery or a supervised 4 7 8 breathing intervention for 5 minutes After a two-day washout period participants will cross over to the alternate intervention and cardiorespiratory parameters will be measured before and after each intervention |