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CTRI Number  CTRI/2023/12/060947 [Registered on: 29/12/2023] Trial Registered Prospectively
Last Modified On: 27/12/2023
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   Effects of grip strengthening exercises on women undergone surgical management for breast cancer 
Scientific Title of Study   Effects of grip strengthening exercises on post-operative breast carcinoma patients.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Joshi 
Designation  MPT student 
Affiliation  Sunandan divatia school of science 
Address  Nanavati Max superspeciality hospital SV road LIC colony vile parle west Mumbai(subarban) Maharashtra

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  8433645805  
Fax    
Email  vaishnavijoshi99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sangeeta Vasudeva  
Designation  Clinical staff physiotherapist 
Affiliation  Sunandan divatia school of science 
Address  Nanavati Max superspeciality hospital SV road LIC colony vile parle west Mumbai(subarban) Maharashtra

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9820745321  
Fax    
Email  physiosangeeta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sangeeta Vasudeva  
Designation  Clinical staff physiotherapist 
Affiliation  Sunandan divatia school of science 
Address  Nanavati Max superspeciality hospital SV road LIC colony vile parle west Mumbai(subarban) Maharashtra

Mumbai (Suburban)
MAHARASHTRA
400056
India 
Phone  9820745321  
Fax    
Email  physiosangeeta@gmail.com  
 
Source of Monetary or Material Support  
Nanavati Max Superspeciality Hospital,LIC Colony, SV Road,Vile Parle(WEST),Mumbai 400056 
 
Primary Sponsor  
Name  Dr. Vaishnavi Joshi 
Address  Dept of Physiotherapy,ground floor,nanavati max superspeciality hospital,sv road,vile parle west 
Type of Sponsor  Other [self] 
 
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 
Dr Ali Irani  Department of physiotherapy Ground floor Nanavati Max Super speciality hospital  Department of physiotherapy Nanavati Max Superspeciality hospital SV road vile parle west
Mumbai (Suburban)
MAHARASHTRA 
0226172329

physiodept.nanavati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nanavati Max Super Speciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  conventional breast physiotherapy and grip strengthening exercises in post operative breast carcinoma patients.  protocol is held for 12 days via telerehab  
Comparator Agent  conventional exercises for post operative breast carcinoma patients   12 session protocol held via telerehab  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  women who underwent surgical management for breast cancer  
 
ExclusionCriteria 
Details  1. Have recent history of hand, wrist, or forearm injuries.
2.other impairments of upper extremity
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• Patient-Rated Wrist/Hand Evaluation (PRWHE)(15 items)
• Jebsen Taylor Hand function test
• Hand grip dynamometer
• Pinch gauge dynamometer
• Visual Analogue Scale
 
post op day 1
day of follow up day 12 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 1/ Phase 2 
Date of First Enrollment (India)   05/01/2024 
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="0"
Months="6"
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  

            

TITL Effects of grip strengthening exercises on hand functions in
post-operative breast carcinoma patients
.

 

INTRODUCTION :-  

Breast cancer is a type of cancer that begins in the breast tissue. It occurs when abnormal cells in the breast grow and multiply uncontrollably, forming a tumor that can invade nearby tissues and spread to other parts of the body. Breast cancer is the most common cancer among women worldwide, with an estimated 2.3 million new cases diagnosed in 2020 alone.

There are several types of breast cancer, including ductal carcinoma in situ, invasive ductal carcinoma, and invasive lobular carcinoma. Risk factors for breast cancer include being female, increasing age, family history of breast cancer, certain gene mutations, personal history of breast cancer or certain non-cancerous breast conditions, and exposure to estrogen. Breast cancer can be diagnosed through a combination of physical exams, imaging tests, and biopsies.

Treatment for breast cancer depends on several factors, including the type and stage of the cancer, the patient’s age and overall health, and the patient’s preferences. Treatment options may include surgery, radiation therapy, chemotherapy, hormonal therapy, targeted therapy, or a combination of these approaches .

Breast cancer screening, early detection, and treatment have improved significantly over the past few decades, leading to better outcomes for many patients. However, breast cancer remains a significant public health concern, and ongoing research is needed to improve prevention, diagnosis, and treatment.

Breast cancer is one of the most commonly diagnosed cancers and a leading cause of cancer-related deaths in women worldwide. The epidemiology of breast cancer includes the incidence, mortality, and prevalence rates of the disease, as well as its risk factors and distribution across different populations.

In 2020, there were an estimated 2.3 million new cases of breast cancer globally, making it the most commonly diagnosed cancer among women worldwide3. The incidence of breast cancer varies across different regions and countries, with higher rates reported in developed countries such as the United States, Canada, and Europe, and lower rates reported in less developed regions such as Africa and South Asia.

The mortality rate of breast cancer has been declining in many countries, likely due to improvements screening, early detection, and treatment. However, breast cancer still accounts for a significant proportion of cancer-related deaths among women. In 2020, there were an estimated 685,000 deaths from breast cancer worldwide.

Breast cancer and its treatment can have significant physical and emotional effects on a patient’s activities of daily living (ADLs). ADLs refer to the basic self-care activities that individuals perform on a daily basis, including bathing, dressing, grooming, feeding, toileting, and mobility.

Breast cancer surgery, such as a mastectomy or lumpectomy, can impact a patient’s ability to perform certain ADLs, particularly in the immediate postoperative period. For example, patients may experience pain, swelling, and limited range of motion in the affected arm, which can make it difficult to perform tasks such as dressing and grooming.

In addition, radiation therapy and chemotherapy can cause fatigue, nausea, and other side effects that may interfere with a patient’s ability to perform ADLs. Emotional distress and anxiety are also common among breast cancer patients, which can affect their motivation and ability to carry out ADLs .

Inclusion criteria:

Women  who have undergone surgical management for breast cancer

 Age 18 to 70

 

 Exclusion criteria:

 Have recent history of hand, wrist, or forearm injuries

 other impairments of upper extremity

Outcome measures:

   Patient-Rated Wrist/Hand Evaluation (PRWHE)(15 items)

     Jebsen Taylor Hand function test

     Hand grip dynamometer

    Pinch gauge dynamometer

    Visual Analogue Scale

 

 


 
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