| CTRI Number |
CTRI/2025/08/093172 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
This study is checking if a type of breathing exercise called Papworth breathing can help people who have breathing problems hold their breath for longer.
|
|
Scientific Title of Study
|
Effect of Papworth Breathing Exercises on breath hold test in breathing dysfunction :An Experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shweta Prashant Ghatage |
| Designation |
Post graduation |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy - DPU Pimpri Pune |
| Address |
Dr. D. Y. Patil College of Physiotherapy ,(cardio -respiratory department ) DPU Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9359971065 |
| Fax |
|
| Email |
shwetaghatage2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mayrui shah |
| Designation |
associate professor |
| Affiliation |
Dr. D.Y. Patil College of Physiotherapy |
| Address |
Dr. D. Y. Patil College of Physiotherapy ,(cardio- respiratory department) DPU Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8087861628 |
| Fax |
|
| Email |
mayuri.shah@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr mayuri shah |
| Designation |
associate professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy - DPU Pimpri Pune |
| Address |
Dr. D. Y. Patil College of Physiotherapy (cardio-respiratory department) DPU Pimpri Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8087861628 |
| Fax |
|
| Email |
mayuri.shah@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shweta Prashant Ghatage |
| Address |
Dr. D.Y Patil College of Physiotherapy,( Cardio-Respiratory department ) Pimpri Pune 411018 |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Prashant Ghatage |
Dr. D. Y Patil College of Physiotherapy -DPU |
Dr. D. Y. Patil College of Physiotherapy ( Cardio Respiratory Department ) Pimpri Pune
411018
Pune
MAHARASHTRA |
09359971065
shwetaghatage2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic individuals |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diaphragmatic breathing technique |
• Prepare the patient in a relaxed and comfortable position in which gravityassist the diaphragm, such as a semi Fowler’s position.
• If your examination revealed that the patient initiates the breathing pattern with the accessory muscles of inspiration(shoulder and neck musculature), start instruction by teaching the patient how to relax thosemuscle (shoulder shrugs coupled with relaxation).
• Place your hand(s) on the rectus abdominis just below the anterior costalmargin. Ask the patient to breath slowly and deeply through nose. Have the patient keep the shoulders relaxed and upper chest quiet, allowing abdomen to rise slightly. Then tell the patient to relax a slowly through the mouth.
• Have the patient practice this technique three or four times and then rest. Do notallow the patient to hyperventilation.If the patient is having difficulty using the diaphragm during inspiration,have the patient inhale several times in succession through the nose byusing a sniffing action. The action usually facilitates the diaphragm.
• To learn how to self- monitor this sequence, have the patient place his or her own hand below the anterior costal margin and feel the movement. The abdomen should rise slightly during inspiration and fall during expiration.
|
| Intervention |
Papworth Breathing Exercises |
Sit or lie down with good posture and close your eyes.
Relax your body and focus on your breath.
Place your hand on your abdomen—breathe through your nose.
Inhale slowly into your abdomen ("breathe in"), hold briefly.
Exhale slowly through your mouth ("relax"), keeping jaw relaxed.
Pause, notice tension, and let it go with each breath.
Stay focused on slow, deep breathing for 5–20 minutes.
Practice daily—start in calm moments, then use in stress. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Score of greater 11 on SEBQ (breathing dysfunction)
2.Yellow or Red Zone will be included on Breath hold test (moderate to severe breathing dysfunction)
3.Both the above criteria should be met to be included in the study
4.Age group- 18-25 years
5.Individuals understanding English language
6.Both Gender
|
|
| ExclusionCriteria |
| Details |
1. Individuals diagnosed with any respiratory disorder
2. Individuals having any type of spinal deformity
3. Individuals who have had recent Rib fractures (2 months ago)
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
Self Evaluation Breathing Questionnaire
Chair
Stop Watch
Stop watch
Stop watch |
2 week |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Other (Terminated) |
| 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
|
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Brief Summary
|
This study aims to evaluate the effect of Papworth Breathing Exercise on breathing dysfunction in healthy, asymptomatic individuals. Breathing dysfunction, despite the absence of any underlying respiratory disease, can be associated with factors such as poor posture, stress, and altered breathing patterns. Even without noticeable symptoms, some individuals exhibit signs of dysfunctional breathing. A randomized controlled trial will be conducted at Dr. D.Y. Patil College of Physiotherapy, involving participants aged 18 to 25 who show signs of breathing dysfunction, indicated by a Self-Evaluation of Breathing Questionnaire (SEBQ) score of less than 11 and a Breath Hold Test falling within the yellow or red zone. Participants will be randomly divided into two groups: Group A will receive Papworth Breathing training, while Group B will practice Diaphragmatic Breathing. The intervention will last for two weeks, with sessions conducted five days per week, gradually increasing from 5 to 20 minutes per session. The SEBQ and Breath Hold Test (Total Lung Capacity and Functional Residual Capacity) will be used as outcome measures, assessed both before and after the intervention. The study aims to compare the effectiveness of these two breathing techniques in improving breathing function in asymptomatic individuals showing signs of dysfunction. |