| CTRI Number |
CTRI/2021/09/036932 [Registered on: 28/09/2021] Trial Registered Prospectively |
| Last Modified On: |
27/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check how the Buteyko breathing technique improves heartrate, spo2, breath holding time and PEFR in pneumonia patients. |
|
Scientific Title of Study
|
Immediate effect of Buteyko breathing technique on heart rate, SpO2, breath holding time and PEFR in patients with pneumonia - A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manjuma DeviS |
| Designation |
MPT Student |
| Affiliation |
Ramaiah medical college |
| Address |
Ramaiah medical college,
Department of Physiotherapy,
M S Ramaiah nagar, MSRIT Post,
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9445820562 |
| Fax |
|
| Email |
manjuma1712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Shaswat Verma |
| Designation |
Assistant professor |
| Affiliation |
Ramaiah medical college |
| Address |
Ramaiah medical college,
Department of Physiotherapy,
M S Ramaiah nagar, MSRIT Post,
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9886591748 |
| Fax |
|
| Email |
shaswatverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manjuma DeviS |
| Designation |
MPT Student |
| Affiliation |
Ramaiah medical college |
| Address |
Ramaiah medical college,
Department of Physiotherapy,
M S Ramaiah nagar, MSRIT Post,
Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9445820562 |
| Fax |
|
| Email |
manjuma1712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manjuma Devi.s
Ramaiah medical college hospital,M s Ramaiah nagar, MSRIT post, Mathikere, Bangalore. |
|
|
Primary Sponsor
|
| Name |
Ramaiah medical college |
| Address |
M S Ramaiah nagar,MSRIT post
Bangalore-560064 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Manjuma DeviS |
M S Ramaiah Hospitals |
Department of Respiratory Medicine,M S Ramaiah Nagar,
MSRIT post, Bangalore 560054
Bangalore
KARNATAKA |
9445820562
manjuma1712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramaiah Medical College Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
buteyko breathing technique |
first step: breath in and breath out through your nose
second step: hpld your breath after breathing out untill you feel the urge to inhale
6 repetations
Duration: as i am checking the immediate effect it is only one of intervention |
| Comparator Agent |
deep breathing exercise |
breath in through your nose
hold the breath for 2 secs
breath out through the mouth
6 repetations
duration: As i am checking immediate effect it is one day of intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ANY TYPE OF PNEUMONIA
NON INTUBATED PATIENTS |
|
| ExclusionCriteria |
| Details |
VENTILATED PATIENTS
PATIENTS WITH TRACHEOSTOMY
ALTERED MENTAL STATE
NO CONSENT
POST COVID PNEUMONIA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate, SpO2, Breath holding time and PEFR |
before intervention and after intervention on the same day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
01/10/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is yet to start |