| CTRI Number |
CTRI/2025/12/098888 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Breathing exercises on lung capacity and physical fitness in breast cancer survivors: A randomized control Trial |
|
Scientific Title of Study
|
Effects of Buteyko Breathing on pulmonary functions, functional capacity and chest expansion on breast cancer survivors- A Randomised control 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 |
Dr Ganesh B R |
| Designation |
Professor and head of CVTS Physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy center, CVTS Department, OPD no 06, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9844855581 |
| Fax |
|
| Email |
drganeshnssofficer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh B R |
| Designation |
Professor and head of CVTS Physiotherapy |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy center, CVTS Department, OPD no 06, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9844855581 |
| Fax |
|
| Email |
drganeshnssofficer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poorva Barve |
| Designation |
Physiotherapy Intern |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy centre, CVTS Department, OPD no 06, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
7021498063 |
| Fax |
|
| Email |
barvepoorva3@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of higher education research, Nehru nagar, Belgaum |
|
|
Primary Sponsor
|
| Name |
KLE Dr. Prabhakar Kore Hospital, Belgaum |
| Address |
OPD no. 39, Sagar floor, Advanced Physiotherapy centre , Dr. Prabhakar Kore Hospital and MRC, Nehru Nagar, Belgaum, Karnatak 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 Ganesh B R |
Dr. Prabhakar kore Hospital, Belgaum 590010 |
KLE Dr. Prabhakar Kore hospital, Advanced physiotherapy center, OPD no 06, Belgaum ,Karnataka 590010, India
Belgaum
KARNATAKA |
9844657561
drganeshnssofficer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of KAHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A Buteyko breathing |
Participants in Group A will receive Buteyko Breathing Excercises. The Technique eill include nasal breathing, breath control, reduced breathing. breath holding after normal exhalation, and relaxation of respiratory muscles. Sessions will be conducted for 15-20 minutes per session, 5 days per week for 6 weeks under supervision of a trained physiotherapist |
| Comparator Agent |
Group B Conventional Physiotherapy |
The subjects in Group B will receive Routine Physiotherapy (Deep breathing and Incentive spirometry). The intervention will include slow deep diaphragmatic breathing performed in a comfortable sitting position and supervised use of a volumetric incentive spirometer. Each session will be continued for15-20 mins for 5 days per week for total duration of 6 weeks under supervision of trained physiotherapist. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed cases of breast cancer of at least one year duration in individuals aged 30-75 years with an eastern Cooperative Oncology Group (ECOG) performance status score of less than 2 |
|
| ExclusionCriteria |
| Details |
Brain metastasis, Communication and psychological problems |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lung function will be measured using spirometry by assessing forced expiratory volume in one second(FEV1) and Forced vital capacity(FVC). Measurements will be taken at baseline and after 6 weeks of intervention. |
Baseline and at the end of 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
Nil |
|
|
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)
|
26/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This is randomised control trial aims to evaluate and compare the effects of the Buteyko breathing technique and routine physiotherapy on pulmonary functions, functional capacity and chest expansion in breast cancer survivors. Breast cancer and its treatments often cause respiratory limitations, fatigue and reduced quality of life due to chest wall restriction and decreased lung volumes. the Buteyko breathing technique which focuses on nasal breathing, controlled breath holding and reduced respiratory rate, may help improve ventilation efficiency and overall well-being . Thirty female breast cancer survivors will be randomly divided into two groups. Group A will receive BBT and group B will receive Routine Physiotherapy, each for 15-20 minutes, three times a week for four weeks. Pulmonary function (FEV1, FVC, FEV1/FVC), Functional capacity (6-Minute walk test) and Chest expansion will be measured before and after intervention. The study is expected to demonstrate that BBT offers greater improvements in respiratory function and exercise tolerance , providing a simple, cost effective and non-invasive approach to enhance rehabilitation outcomes in breast cancer survivors. |