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CTRI Number  CTRI/2025/09/094408 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 04/09/2025
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   Effect of prehabilitation on handgrip strength following axilla surgery in breast cancer patient 
Scientific Title of Study   Effect of prehabilitation on handgrip strength following axillary lymph node dissection in breast cancer patients – A randomized control trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aditya Arnav 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of General Surgery, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9064036608  
Fax    
Email  aditya_arnav@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudhir Kumar Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of General surgery, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  7536049904  
Fax    
Email  singhsudhirimsbhu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditya Arnav 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, Rishikesh 
Address  Department of General Surgery, AIIMS Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand

Dehradun
UTTARANCHAL
249203
India 
Phone  9064036608  
Fax    
Email  aditya_arnav@yahoo.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Virbhadra road, Rishikesh, Dist: Dehradun, Uttarakhand, Pin: 249203, India 
 
Primary Sponsor  
Name  Dr Aditya Arnav 
Address  Department of General surgery, AIIMS, Rishikesh, Virbhadra Road, Rishikesh, Uttarakhand 
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 Aditya Anrav  All India Institute of Medical Sciences, Rishikesh  Department of General Surgery, AIIMS Rishikesh, Virbhadra Road, 249203
Dehradun
UTTARANCHAL 		 9064036608

aditya_arnav@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  None  Patients in control group will under go regular treatment as per the NCCN and Institutional guidelines.  
Intervention  Structured Upper limb exercises  Hand, Wrist, and Elbow Exercises (sitting or lying down) a. Fist squeezes: Extend fingers and then gently squeeze to make a fist. b. Flex and extend wrist. c. Flex elbow until the hand touches shoulder and then extend elbow. Shoulder Exercises a. Arm lift: With hands clasped together and elbows extended, lift arms upward toward head until you feel a gentle stretch. Pause and slowly return to starting position. b. Sideways stretches: With elbows extended, make an “angel in the snow” pattern on the bed or floor with both upper extremities. c. While lying on back, externally and internally rotate shoulders with elbows flexed and shoulders abducted to 90°. d. In standing position, gently extend the involved arm backward to the point of discomfort. Try to swing the arm a little while walking At least 10 repetitions twice daily 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Women aged 18 to 70 years.
Diagnosed with stage I to III breast cancer as per AJCC 8th edition planned for ALND or Completion ALND.
Patient planned for NACT as per NCCN Guidelines 4.2024.
Willing to participate in the Prehabilitation program. 
 
ExclusionCriteria 
Details  Patients undergoing Breast surgery where pectoralis muscle is involved.
Patients who require Flap Reconstruction of Breast.
Patients with a history of prior axillary surgery, breast reconstruction or prior upper limb surgical interventions, previously diagnosed musculoskeletal impairment or trauma of upper limb.
Pregnant and Lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. patients who have undergone prehabilitation with structured upper limb exercises have better hand grip strength after ALND as compared to those who have not.   1 month post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/10/2025 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Patients diagnosed with Breast carcinoma with Metastasis to I/L Lymph nodes and have undergone NACT, planned for ALND are screened according to Inclusion and exclusion criteria. Informed consents taken and selected patients are asked to choose a pre numbered sealed envelops thus divided into 2 groups, namely Prehabilitation group and Control group. Prehabilitation group is asked to follow a structured upper limb exercise routine for 6 weeks. Assessment of Handgrip strength is done once before starting prehabilitaiton, 1 day before surgery, and 1 month after surgery. Assessment is done by a blinded examiner who does not know which group the patient belongs to. Hand grip strength is measured using Camry Digital Handgrip Dynamometer (Model EH101). The participants will be seated on a chair with arm rest and hold the hand dynamometer with their shoulder relaxed, their forearm supported in a neutral position and their elbow flexed at 90 degrees. The greatest outcome for ipsilateral HGS will be recorded after 3 consecutive readings, 5 minutes apart. Following which statistical analysis of the data is done.  
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