| 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
|
|
|
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
|
|
|
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. |