| CTRI Number |
CTRI/2024/05/066633 [Registered on: 01/05/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Chest physiotherapy on Respiratory Function, Chest Expansion, and Functional Capacity in Post-Modified Radical Mastectomy Patients |
|
Scientific Title of Study
|
EFFECT OF COMPREHENSIVE CHEST MOBILITY PROTOCOL ON PULMONARY FUNCTION, CHEST EXPANSION,AND FUNCTIONAL CAPACITY IN PATIENTS UNDERWENT MODIFIED RADICAL MASTECTOMY : A RANDOMIZED 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 |
Tanvi Varma |
| Designation |
PG student |
| Affiliation |
Ravi nair physiotherapy college |
| Address |
Department of cardio respiratory physiotherapy ,Ravi nair physiotherapy college datta meghe institute of higher eduucation and research sawangi ( meghe) wardha maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020483377 |
| Fax |
|
| Email |
tanvivarma96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr vaishnavi yadav |
| Designation |
Associate professor |
| Affiliation |
Ravi nair physiotherapy college |
| Address |
Department of cardio respiratory physiotherapy Ravi nair physiotherapy college datta meghe institute of higher eduucation and research sawangi ( meghe) wardha maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9595751274 |
| Fax |
|
| Email |
vaishnavi1326@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vaishnavi yadav |
| Designation |
Associate professor |
| Affiliation |
Ravi nair physiotherapy college |
| Address |
Department of cardio respiratory physiotherapy Ravi nair physiotherapy college datta meghe institute of higher eduucation and research sawangi ( meghe) wardha maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9595751274 |
| Fax |
|
| Email |
vaishnavi1326@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi nair physiotherapy college ,Siddharth gupta memorial cancer hospital,Sawangi (Meghe),Wardha, India |
|
|
Primary Sponsor
|
| Name |
Ravi nair physiotherapy college |
| Address |
Department of Cardio respiratory Physiotherapy , Ravi nair physiotherapy , college,Datta meghe institute of higher education and research sawangi (meghe) wardha , maharashtra 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 |
| Tanvi S Varma |
Siddharth gupta memorial cancer hospital |
Department of Cardiorespiratory physiotherapy, Ravi nair physiotherapy college, Datta meghe institute of higher education and research, Sawangi (Meghe), Wardha, Maharashtra
Wardha
MAHARASHTRA |
7020483377
tanvivarma96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,DMIHER(DU) |
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 |
Comphrehnsive Physiotherapy |
A comprehensive chest mobility protocol will be given 3 times in a week for 12 weeks including chin tucks, sternocleidomastoid and upper trapezius stretching, diaphragm mobility, thoracic rotation exercises, intercostal muscle stretch, endothoracic fascia manipulation, pectoral muscle stretch, and scapular muscle activation exercises aims to improve chest mobility, flexibility, and overall function. |
| Intervention |
Conventional Physiotherapy Group |
Conventional physiotherapy will be give 3 times in a week for 12 weeks includes patient education, posture training, active range of motion exercises for the cervical spine and shoulders, deep breathing exercises, and squeeze ball exercises. These interventions aim to improve mobility, posture, and muscle strength, aiding in rehabilitation and recovery. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria:
Female subject
Patients underwent modified radical mastectomy
Age group of 40-50 yrs |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Patient with severe musculoskeletal, neurological, and psychological dysfunction
Patient having any chest trauma
The patient has an infection at the incision site
Patient unwilling to participate
Patient with any deformility
Patient without inform consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
pulmonary function test
chest expansion |
outcomes will be assessed at baseline and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
functional capacity
|
outcomes will be assessed at baseline and after 12 weeks |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/05/2024 |
| 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 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 aim of the study is to find out the effect of comprehensive chest mobility protocol on pulmonary function, chest expansion, and, functional capacity in patients who underwent modified radical mastectomy To evaluate the effect of Comprehensive chest mobility protocol as an adjunct to conventional physiotherapy treatment on pulmonary function, chest expansion,gait parameters, functional capacity in patients undergone modified radical mastectomy
To evaluate the effect of conventional physiotherapy on pulmonary function, chest expansion,gait parameters, functional capacity in patients undergone modified radical mastectomy and To compare effect of conventional physiotherapy treatment and comphrensive physiotherapy treatment on pulmonary function, chest expansion,gait parameters, functional capacity in patients undergone modified radical mastectomy
|