| CTRI Number |
CTRI/2019/09/021281 [Registered on: 17/09/2019] Trial Registered Prospectively |
| Last Modified On: |
07/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physiotherapy (including YOGA)] |
| Study Design |
Other |
|
Public Title of Study
|
Added effect of pranayama & respiratory muscle training on patients undergoing coronary artery bypass surgery-A randomized control trial |
|
Scientific Title of Study
|
ADDED EFFECT OF PRANAYAMA & RESPIRATORY MUSCLE TRAINING ON PAIN, ANXIETY AND STRENGTH IN PATIENTS UNDERGOING CORONARY ARTERY BYPASS SURGERY- 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 |
SUSHNA P |
| Designation |
Post graduate student |
| Affiliation |
Department of CTVS |
| Address |
NITTE Institute of Physiotherapy, Derlakatte Mangalore
Jutice K S Hegde hospital, Derlakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9656789892 |
| Fax |
|
| Email |
sushna.20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanesh Kumar K U |
| Designation |
Principal |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
NITTE Institute of Physiotherapy
Jutice K S Hegde hospital, Derlakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanesh Kumar K U |
| Designation |
Principal |
| Affiliation |
NITTE Institute of Physiotherapy |
| Address |
NITTE Institute of Physiotherapy
Jutice K S Hegde hospital, Derlakatte Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE University NITTE Institute of Physiotherapy, DerlakattenMangalore |
|
|
Primary Sponsor
|
| Name |
NITTE UNIVERSITY |
| Address |
NITTE Institute of Physiotherapy Derlakatte Mangalore |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Sushna P |
Cardio thoracic and vascular surgery department (CTVS) |
Department of CTVS,Jutice K S Hegde hospital, Derlakatte Mangalore
Dakshina Kannada
KARNATAKA |
9656789892
sushna.20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Anuloma Viloma pranayama
2.Nadisuddhi pranayama
3.Inspiratory muscle training |
1.Anuloma viloma pranayama
repititions :9 rounds
frequency : twice a day
2. Naisuddhi pranayama
Repititions : 9 rounds
frequency: twice a day
3. Inspiratory muscle training
Repititions: 30 breaths, with short breaks
frequency : twice a day |
| Comparator Agent |
1.Deep breathing maneuver
2.Incentive spirometry
3.Coughing techniques |
1.Deep breathing maneuver
Repititions:4 times
Frequency : twice a day
2.Incentive spirometry
Repititions: 10times
Hold time: 3sec
Frequency:10min each hour
3.Coughing techniques
3-4 diaphragmatic breathing before coughing,
take a deep breath -hold for three seconds, tighten the abdominal muscles and cough twice
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing CABG surgery
2. Age group 30-70 years
3. Both male and female |
|
| ExclusionCriteria |
| Details |
1.Patients undergoing multiple surgery
2.Emergency CABG
3.Patient who are not interested
4.History of CVA
5.Presence of neuromuscular disorder
6.Aneurysm
7.Cardiovascular instability
8.Those with LVEF less than30%
|
|
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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 |
| Visual analog scale (VAS scale) |
Visual analog scale- pre intervention and on post operative day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Beck Anxiety Scale |
Beck Anxiety Scale - pre intervention and on post operative day 5. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/09/2019 |
| Date of Study Completion (India) |
10/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/02/2020 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The present study has been undertaken in order to evaluate the added effect of pranayama and respiratory muscle training on pain, anxiety and strength on patients undergoing CABG surgery. The patient undergoing CABG surgery was recruited randomly using randomization method and treatment was given to their respective group. Experimental group received pranayama and inspiratory muscle training preoperative days and postoperatively from day4 to pod-7 along with usual care. Control group received deep breathing manuever,ACBT and incentive spirometry along with usual care. Primary outcome measure was VAS and secondary outcome scale was BAI scale |