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CTRI Number  CTRI/2025/04/085893 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Inverse ratio breathing on chest expansion and functional capacity in post mastectomy women. 
Scientific Title of Study   Effect of Inverse ratio breathing on chest expansion and functional capacity in post mastectomy women. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rucha Jodh  
Designation  Post Graduation  
Affiliation  Datta meghe college of physiotherapy, nagpur 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College Of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road , Nagpur MAHARASHTRA 441110 INDIA

Nagpur
MAHARASHTRA
441110
India 
Phone  9579312920  
Fax    
Email  ruchajodh2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sachin Annaji Chaudhary 
Designation  Principal and Professor  
Affiliation  Datta Meghe College Of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College Of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road , Nagpur MAHARASHTRA 441110 INDIA

Nagpur
MAHARASHTRA
441110
India 
Phone  9960898805  
Fax    
Email  drsachin1982@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rucha Jodh  
Designation  Post Graduate  
Affiliation  Datta Meghe College Of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College Of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road , Nagpur MAHARASHTRA 441110 INDIA

Nagpur
MAHARASHTRA
441110
India 
Phone  9579312920  
Fax    
Email  ruchajodh2000@gmail.com  
 
Source of Monetary or Material Support  
Shalinitai meghe hospital and research centre hingna road , wanadongri, nagpur441110, maharashtra india  
 
Primary Sponsor  
Name  Datta Meghe College Of Physiotherapy 
Address  Datta Meghe College Of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road , Nagpur MAHARASHTRA 441110 INDIA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRucha Jodh  Shalinitai meghe hospital and research centre  Shalinitai meghe hospital and research centre , wanadongri, hingana road nagpur,441110 female surgery ward no 07
Nagpur
MAHARASHTRA 
9579312920

ruchajodh2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta meghe Ayurved, Physiotherapy, Nursing (APN) Institutional Ethics committe(IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z901||Acquired absence of breast and nipple,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy   Conventional physiotherapy will be given includes progressive active assisted and assisted shoulder exercise, strengthening exercises and chest mobility exercises, bilateral shoulder abduction, breathing exercises associated with flexion and extension of trunk to improve chest expansion and shoulder mobility, segmental breathing exercise till POD-3 to POD-8. 
Intervention  Inverse ratio breathing exercise with conventional physiotherapy.  The subjects will be instructed to carry out inspiration for 4 seconds at a constant speed and to carry out expiration for 2 seconds. These breathing technique will performed for 1 minute, then 1 minute rest will given, again breathing technique will be given for 1 min followed by 1 min rest. Likewise for total 10 minutes. These breathing technique will be given for 6 consecutive days (twice a day) in addition to physiotherapy sessions from POD 3 to POD 8. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1.Patient who underwent modified radical mastectomy
2.Patients referred for physiotherapy following
modified radical mastectomy.

 
 
ExclusionCriteria 
Details  1.Past medical history of any cardiovascular system or respiratory disease.
2.Patients who are non-cooperative or with any psychological problems.

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Chest expansion measurement with the help of inelastic measuring tape.
 
pre-intervention on at the baseline on POD-3 and post intervention on POD-8 i.e after 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
6 Minute Walk Test  pre-intervention on POD-3 at the baseline & post intervention after one week POD-8  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   20/05/2025 
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="1"
Months="0"
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 study investigates the effectiveness of Inverse Ratio Breathing (IRB), a technique that adjusts the inspiration-to-expiration ratio to 2:1, in improving respiratory mechanics and functional capacity in women recovering from a modified radical mastectomy. The goal is to compare IRB combined with standard physical therapy to physical therapy alone to determine its potential as a rehabilitation strategy for post-mastectomy complications. Post-mastectomy complications often impair breathing and functional capacity. Conventional breathing exercises improve chest expansion but may have limitations. The objective of the study is to assess whether IRB enhances chest expansion and functional capacity more effectively than conventional methods. 66 women post-mastectomy divided into two groups:Group A: IRB + physical therapy and Group B: Physical therapy only. Inclusion criteria is post-mastectomy women referred for physiotherapy and patient with the history of cardiovascular/respiratory diseases or psychological issues will be excluded. Pre-assessment Thoracic expansion measurements for chest mobility  and 6-Minute Walk Test (6MWT) for functional capacity will be examine on POD -3 and post assessment  on POD- 8. Specific exercises will be deliver according to group allocation.

 
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