| CTRI Number |
CTRI/2024/04/065307 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| 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
|
A comparison between two different breathing techniques on lung function in muscular dystrophy |
|
Scientific Title of Study
|
Respiratory training interventions in Muscular Dystrophy: A comparative analysis of Buteyko Breathing Technique and Inspiratory Muscle Training on Lung function |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapil Upadhyay |
| Designation |
Research Scholar |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Physiotherapy department
division- Q block
room no. QG 07
Faridabad
HARYANA
121004
India |
| Phone |
9899581210 |
| Fax |
|
| Email |
upadhyaykapil1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Kumari |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Physiotherapy department
division - Q block
room no. QG 07
Faridabad
HARYANA
121004
India |
| Phone |
8800125047 |
| Fax |
|
| Email |
sunita.fas@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Kumari |
| Designation |
Assistant Professor |
| Affiliation |
Manav Rachna International Institute of Research and Studies |
| Address |
Manav Rachna International Institute of Research and Studies
Physiotherapy department
division - Q block
room no. QG 07
Faridabad
HARYANA
121004
India |
| Phone |
8800125047 |
| Fax |
|
| Email |
sunita.fas@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research and Studies
manav rachna campus Rd, Gadakhor Basti Village, sector 43, faridabad, haryana, pincode-121004
india |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
None
|
| Type of Sponsor |
Other [None] |
|
|
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 Sunita kumari |
Manav Rachna International Institute of Research and Studies |
department of physiotherapy neurology physiotherapy lab Q-block room number - QG 07, MRIIRS sector 43 Aravalli Hills Surajkund road
Faridabad
HARYANA |
08800125047
sunita.fas@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee, school of allied health sciences, Manav Rachna institute of research and studies, faridabad , haryana , india |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G710||Muscular dystrophy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko breathing technique |
Buteyko breathing technique will be practiced for 15 minutes for five days a week for 4 weeks.
Preparation
1. Should be sit down or in a chair.
2.Join the spine to stay upright.
3.Relax the respiratory muscles.
4.Breathe normally for a few minutes.
The Control Pause
1. After taking a deep breath, should be hold the breath.
2. After that should be used the index finger and thumb to connect the nose.
3. Hold the breath until feeling the urge to breathe, which may involve the non-engaging
movement of the diaphragm, and then exhale.
4. Should be breathing normally for at least 10 seconds.
5. Should be repeat several times.
Maximum pause
1. After taking a deep breath, should be hold the breath.
2. After that should be Use of index finger and thumb to connect the nose.
3. Keep the air as long as possible, usually twice the length of the Control Period.
4. Until reached the level of moderate discomfort, should be pull.
5. Should be breathing normally for at least 10 seconds.
6. Should be repeat several times.
During the breathing sessions participants’ oxygen saturation will be continuously monitored for patient safety.
|
| Comparator Agent |
Inspiratory muscle training |
For the purpose of training Philips Threshold® IMT Inspiratory Muscle Trainer will used.
1.The mouth piece of the threshold trainer was put inside the participant’s mouth and nose clip was attached to prevent any breathing through the nose.
2.The participants were instructed to breathe in a force to overcome the resistance of a spring-loaded valve and enable airflow. The resistance was increased to the next level as the participants completed 50 breathes without any difficulty for consecutive 3 days.
Participants repeated this manoeuvre for 15 minutes with 2–3 minutes rest periods in between. Intervention will be given for 5 days a week for 4 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Duchenne Muscular Dystrophy patients
Free from respiratory tract infections |
|
| ExclusionCriteria |
| Details |
Presence of Other Significant Respiratory Conditions e.g., severe chronic obstructive pulmonary disease
Participants who have undergone recent respiratory surgery or procedures that may impact lung function should be excluded
Impaired cognition
Any hearing or visual defect |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Forced vital capacity (FVC)
2. Forced expiratory volume in one second (FEV 1)
3. FEV1/FVC ratio
4. PEFR
5. Chest expansion measurement
|
Pre interventional assessment and post interventional assessment will be taken of the outcome measures between the time period of 4 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/04/2024 |
| 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="0"
Months="4"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
To assess and compare the effect of Buteyko breathing technique and Inspiratory muscle training on lung function in individuals diagnosed with muscular dystrophy. Muscular dystrophy is a group of genetic disorders characterized by progressive muscle weakness, including respiratory muscles, which often leads to compromised lung function. This comparison can help identify which approach, if any, is more beneficial for individuals with muscular dystrophy, guiding healthcare professionals in selecting appropriate interventions. Enhancing respiratory function in this population is of paramount importance for improving overall quality of life.
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