| CTRI Number |
CTRI/2025/04/084178 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Buteyko Breathing on Health and Fitness After Heart Valve Surgery |
|
Scientific Title of Study
|
Effect of Buteyko breathing and functional exercise capacity in valvular surgeries. A Randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garima Sharma |
| Designation |
MPT Student |
| Affiliation |
Department of Physiotherapy, Gurugram University |
| Address |
Department of Physiotherapy, Gurugram University Sector 87, Gurugram, Haryana, 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8168674032 |
| Fax |
|
| Email |
ginnisharma68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonia |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy, Gurugram University |
| Address |
Department of Physiotherapy, Gurugram University sector 87, Gurugram, Haryana, 122505
Gurgaon
HARYANA
122505
India |
| Phone |
9416414362 |
| Fax |
|
| Email |
sonia@gurugramuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Garima Sharma |
| Designation |
MPT Student |
| Affiliation |
Department of Physiotherapy, Gurugram University |
| Address |
Department of Physiotherapy, Gurugram University sector 87, Gurugram, Haryana, 122505
Gurgaon
HARYANA
122505
India |
| Phone |
8168674032 |
| Fax |
|
| Email |
ginnisharma68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Gurugram University, Sector 87, Kankrola Village, Gurugram, Haryana, India, 122505 |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Gurugram University, Sector 87, Gurugram, 122505 |
| Type of Sponsor |
Other [University] |
|
|
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 |
| Garima Sharma |
Civil Hospital, Ambala Cantt, Haryana |
Department of Physiotherapy, Civil Hospital, Ambala Cantt
Ambala
HARYANA |
91 8168674032
ginnisharma68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Department of Physiotherapy, Gurugram University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post Valvular Surgery |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyo Breathing Exercise with Thoracic Chest Expansion |
Buteyo Breathing Exercise with Thoracic Chest Expansion performed by post valvular surgery patients for 1 week daily for 30 minutes daily |
| Comparator Agent |
Diaphragmatic Breathing exercise with Thoracic chest expansion |
Diaphragmatic Breathing exercise with Thoracic chest expansion performed by post valvular surgery patients for 1 week for 30 minutes daily. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with Valve Replacement surgeries with post operative day 0
2. Both male and female
3. Subjects who can stand for at least 2 minutes without support.
4. Subjects of age 45 to 70 years
5. Degenerative valve replacement surgeries
|
|
| ExclusionCriteria |
| Details |
1. Subjects with any other Neurological or musculoskeletal impairment that would interfere
in the participation in the study.
2. Subjects staying on ventilator for more than 3 days from the day of surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate, Respiratory Rate, Blood Pressure, Spo2, Dyspnea |
Baseline and After 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Arterial Blood Gas |
Baseline and After 1 week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
14/04/2025 |
| 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="2"
Days="14" |
|
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
|
The Buteyko Breathing Technique (BBT), which is named after its inventor Konstantin Pavlovich
Buteyko, is one of the breathing technique that aims to regulate breathing. By alternating between
periods of controlled breathing reduction and breath holding. One such key techniques proven to
aid in the management of post cardiac surgery pulmonary complication. The most significant contributor to post-operative complications is prolonged bed rest. Postoperative bed rest can contribute to multiple organ system dysfunction. Immobilization impairs
oxygen transport ability, increases the risk of developing lower extremity deep vein thrombosis
and even pulmonary thrombo embolism, and causes decrease in muscle mass and muscle strength.
Despite these negative effects, bedding is prescribed after surgery. As for patients who had cardiac
surgery, activity limitation has been presented to diminish cardiac overload. Early mobilization
after surgery has many benefits, including increasing ventilation, muscle strength, and functional
ability. Postoperative pulmonary complications are a common cause of morbidity and mortality in patients
undergoing cardiac surgery, leading to an increase in length of hospital stay and healthcare costs.
Breathing therapy exercises are a well-accepted intervention, introduced as treatment for cardiac
surgery patients. The aim of these exercises, in the early postoperative period, is to reduce the risk
of PPC, functional capacity impairment, and length of hospital stay due to altered pulmonary
function. |