| CTRI Number |
CTRI/2023/02/049373 [Registered on: 01/02/2023] Trial Registered Prospectively |
| Last Modified On: |
31/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Additive Effect Of Buteyko Breathing Technique With Aerobic Exercise In Post Operative Breast Cancer Patients |
|
Scientific Title of Study
|
Additive Effect Of Buteyko Breathing Technique With Aerobic Exercise On Pulmonary
Function And Quality Of Life In Post Operative Breast Cancer Patients: An Experimental Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raymol Mohanrao Dagani |
| Designation |
Master of Cardiovascular and Respiratory Physiotherapy Student |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambajogai road Latur
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
8655747677 |
| Fax |
|
| Email |
raymoldagani@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishvanath Pawadshetty |
| Designation |
Professor and HOD of Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambajogai road Latur
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
8655747677 |
| Fax |
|
| Email |
physiovish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishvanath Pawadshetty |
| Designation |
Professor and HOD of Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
Maharashtra Institute of Physiotherapy |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambajogai road Latur
Latur
Latur
MAHARASHTRA
413512
India |
| Phone |
8655747677 |
| Fax |
|
| Email |
physiovish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra Institute of Physiotherapy Latur |
|
|
Primary Sponsor
|
| Name |
Maharashtra Institute of Physiotherapy Latur |
| Address |
Maharashtra Institute of Physiotherapy MIMSR Medical Campus Ambajogai Road Latur |
| 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 |
| Dr Raymol Dagani |
yashvantrao chavan rural hospital, maharashtra institute latur |
Department of Cardiovascular and respiratory physiotherapy 15 physiotherapy department, MIMSR Medical Campus Ambajogai Latur
Latur
MAHARASHTRA |
8655747677
raymoldagani@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharashtra Institute Of Physiotherapy Ethical Committee |
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 |
| Intervention |
Buteyko Breathing technique, aerobic exercise |
Buteyko Breathing technique given for 20 mins and cycle ergometry of upper limb for 10 mins and brisk walking for 10 mins with warm up and cool down. whole protocol is followed for 3 weeks frequency 5 times duration is 3 weeks |
| Comparator Agent |
Nil |
Nil
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
known case of post operative breast cancer patients
Patients rating of perceived exertion from mild to moderate on Borg Scale
Patients willingly able to participate in exercise activities
|
|
| ExclusionCriteria |
| Details |
Patients with history of asthma & COPD
Lower limb deformities
Patients with history of accidental upper & lower limb trauma
Patients with recent history of cardiac disease
Mental disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcomes are Pulmonary function test(FVC,FEV1,FEV1/FVC) and EORTC QOLQ C30 version 3 |
Baseline 1st Day and at the end of 3rd week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no secondary outcomes |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2023 |
| 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 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My study is to see Additive Effect Of Buteyko Breathing Technique With Aerobic Exercise On Pulmonary
Function And Quality Of Life In Post Operative Breast Cancer Patients. sample size is 62. outcome measures are FVC,FEV1,FEV1/FVC ratio and other outcome measure is health related quality of life measured by EORTC QOL C30 version 3. |