| CTRI Number |
CTRI/2024/07/070329 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Unveiling the power of Dynamic Neuromuscular Stabilization Breathing and Buteyko Breathing |
|
Scientific Title of Study
|
Unveiling the power of Dynamic Neuromuscular Stabilization Breathing and Buteyko Breathing-A Comparative Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MUSKAN |
| Designation |
UG Student |
| Affiliation |
Maharishi Markendeshwar Deemed to be university mullana haryana |
| Address |
Exercise laboratory Room no. 2 Ground floor Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala Haryana India 133207
Ambala HARYANA 133207 India |
| Phone |
8437798717 |
| Fax |
|
| Email |
danimuskan13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shweta Sharma |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Deemed to be University Mullana Ambala Haryana |
| Address |
Exercise laboratory Room no. 2 Ground floor Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala Haryana India 133207
Ambala HARYANA 133207 India |
| Phone |
8860405721 |
| Fax |
|
| Email |
shwetasharmampth27@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shweta Sharma |
| Designation |
Assistant professor |
| Affiliation |
Maharishi Markandeshwar Deemed to be University Mullana Ambala Haryana |
| Address |
Exercise laboratory Room no. 2 Ground floor Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana Ambala Haryana India 133207
Ambala HARYANA 133207 India |
| Phone |
8860405721 |
| Fax |
|
| Email |
shwetasharmampth27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana district Ambala Haryana India 133207 |
|
|
Primary Sponsor
|
| Name |
Muskan |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana district Ambala Haryana India 133207 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shweta Sharma |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation Maharishi Markandeshwar Deemed to be University Mullana district Ambala Haryana India 133207 Ambala HARYANA |
8860405721
shwetasharmampth27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Buteyko Breathing Technique
3 days a week for 4 weeks |
Buteyko Breathing Technique
Duration 4 weeks
Frequency 3 days a week |
| Intervention |
Dynamic neuromuscular stabilisation breathing
3-days a week for 4 weeks |
Dynamic Neuromuscular Stabilization Breathing
Duration 4 weeks
Frequency 3 days a week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals
Patient agreement
|
|
| ExclusionCriteria |
| Details |
Any ongoing medication
Any ongoing cardiovascular condition
Any previous surgeries |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
12 minute walk test to evaluate VO2 max
|
2 time points |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Karvonen formula to evaluate Target Heart Rate |
2 time points |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2024 |
| Date of Study Completion (India) |
20/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
There has been a growing interest in using specific breathing techniques to enhance people’s general wellness and health in recent years. Dynamic Neuromuscular Stabilization (DNS) and Buteyko Breathing (BBT) are two of these methods that have attracted a lot of interest due to their potential benefits. These methods have shown promise in practical aspect, but it is yet unclear how they will affect well-being among individuals who are actively seeking wellness and health optimization. This study aims to bridge the current gap in knowledge and offer a thorough insight into the potential cardiorespiratory benefits linked to DNS and BBT breathing techniques. In this 4-week pilot study, a total of 40 participants will be assigned randomly to two groups: Group A received DNS and Group B practiced Buteyko breathing. The participants are selected through a random sampling method, ensuring they met specific criteria, such as age, and the absence of ongoing medication, respiratory, or cardiovascular conditions. The primary objective is to evaluate how these breathing techniques influenced cardiovascular endurance, utilizing parameters like VO2 max and target heart rate, with assessments conducted before the study, and at the and the 4-week conclusion. Each group will follow distinct breathing protocols during the 4-week training period, and a final assessment allows for comparisons within and between the groups. |