| CTRI Number |
CTRI/2023/07/055543 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
21/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
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Public Title of Study
|
Evaluating the effect of inspiratory muscle trainner on the respiratory muscle strength in children with respiratory conditions
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Scientific Title of Study
|
Acute effect of inspiratory muscle training on respiratory muscle function in children with respiratory conditions – A quasi experimental study.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zayan Zubaida |
| Designation |
PG student |
| Affiliation |
Post graduate Student |
| Address |
"ADAMS" Jayashree gate, Bikernakatte, Kulshekar post, Mangalore
Department of Physiotherapy, Kasturba Medical College, Center for Basic Sciences, Bejai, Mangalore- 575 004
Dakshina Kannada
KARNATAKA
575005
India |
| Phone |
8762610095 |
| Fax |
|
| Email |
zayanzubaida@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shreekanth D Karnad |
| Designation |
Assistant Professor- Senior Scale |
| Affiliation |
Assistant Professor senior scale |
| Address |
Department of Physiotherapy, Kasturba Medical College, Center for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9035551146 |
| Fax |
|
| Email |
shrikanth.dk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Faiqa Hanif |
| Designation |
PG student |
| Affiliation |
Post graduate student |
| Address |
Department of Physiotherapy, Kasturba Medical College, Center for Basic Sciences, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7349353611 |
| Fax |
|
| Email |
faiqahanifs@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Physiotherapy, Kasturba Medical College, Center for Basic Sciences, Bejai, Mangalore- 575 004
|
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Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Department of Physiotherapy, Kasturba Medical College, Center for Basic Sciences, Bejai, Mangalore- 575 004
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| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nutan Kamath |
Kasturba Medical College |
Department of Physiotherapy, 2nd floor, Room number 2.
Dakshina Kannada
KARNATAKA |
9448147687
nuthan.kamath@manipal.edu |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College, Mangalore |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inspiratory muscle training using Threshold IMT |
Duration of the therapy will be up to 45 minutes for minimum of 5 days
IMT type – Threshold IMT Frequency – 2 times/day
Patient position and exercise procedure: The child will be made to sit on the bed or the chair with the back support. IMT device usage: A nose clip will be placed to prevent the child from breathing through the nose during IMT training. The child will be instructed to keep the lips firmly to the mouthpiece of IMT and take 15 breaths with 10-sec rest intervals for 15 min. The intensity of IMT will be started with 40 % of MIP and graduated based on comfort and individual condition. This training will be along with routine therapy. |
| Comparator Agent |
Non- IMT |
Duration of therapy will be up to 45 minutes along with routine therapy, the child will receive the following types of exercises Duration – Minimum of 5 days
Frequency – 2 times/day Patient position and exercise procedure: The child will be made to sit on the bed or the chair with the back support. The child will be instructed to perform the following exercises and take 15 breaths with 10-sec rest intervals for 10 min each.
1. Breathing ball visualization (Hoberman sphere) – Inhale through your nose as the ball expands, pause and then exhale through your nose as the ball contracts.
2. Blowing bubbles (controlled breaths) – the child will be instructed to blow bubbles.
3. Transferring paper balls – the child will be instructed to transfer paper balls from 1 cup to another by taking a deep breath to suck them onto the end of the straw and holding
them while they’re transferred.
4. Blowing balloons – the child will be instructed to blow a balloon with the lips sealed
onto a mouthpiece.
5. Dragons breath – the child will be instructed to hold the hands beneath the chin, with
the fingers interlaced, and while breathing in through the nose, lifting the elbows up. Tip the head out, and exhale through the mouth, unleashing the hot breath of a dragon. Lower the elbows with the exhalation.
6. Paper blowing exercise – the child will be instructed to blow onto a tissue paper.
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Inclusion Criteria
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| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1) Medically stable children with a diagnosis of a respiratory condition with any degree
of severity.
2) Children who will be undergoing therapy for a minimum of 5 days in the hospital.
|
|
| ExclusionCriteria |
| Details |
1) Children with acute respiratory failure.
2) Children with cognitive impairment.
3) Children with pre-existing respiratory conditions (E.g. cystic fibrosis)
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Method of Generating Random Sequence
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Method of Concealment
|
|
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Blinding/Masking
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Primary Outcome
|
| Outcome |
TimePoints |
1. Maximal inspiratory pressure.
2. Maximal expiratory pressure. |
Day 1 - Day 6 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Maximal inspiratory pressure.
2. Maximal expiratory pressure. |
Day 1- Day 6 |
|
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Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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 |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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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
|
The purpose of this study is to assess the acute effect of IMT training and non-IMT training on respiratory muscle function in children with respiratory conditions.Those fulfilling the inclusion will be assessed, and the demographics noted. The children will then be grouped into either the IMT or non-IMT groups. All the included children will be assessed for MIP and MEP using Micro RPM on the 1st day of inclusion before the treatment and on the 6th day. The study will be a preliminary step towards assessing the acute effect of IMT training compared with non-IMT training. If either of the group is found to be effective in bringing changes in the values of respiratory muscle function, then these strategies may be evaluated further using a good clinical trial as well as this strategy may be included in the routine exercises to improve the respiratory muscle function as well as to prevent the secondary complications. |