| CTRI Number |
CTRI/2025/10/096328 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Nurse-directed pre-operative exercise program on post operative shoulder range of motion and pain in patients undergoing axillary lymph node dissection (ALND). |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of a nurse-directed pre operative exercise program on post operative shoulder range of motion and pain in patients undergoing axillary lymph node dissection (ALND) in a tertiary care hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NABEENA PAUL |
| Designation |
M.Sc nursing Student |
| Affiliation |
AIIMS Mangalagiri, college of nursing |
| Address |
Room no: 103. 1st floor, College of Nursing. AIIMS Mangalagiri. Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
6290734301 |
| Fax |
|
| Email |
paulnabeena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Muthuvenkatachalam S |
| Designation |
Associate professor |
| Affiliation |
AIIMS Mangalagiri, college of nursing |
| Address |
Room No:407. 4th floor. college of nursing. AIIMS Mangalagiri. Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9410366146 |
| Fax |
|
| Email |
muthu.venky@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NABEENA PAUL |
| Designation |
M.Sc nursing 2nd yr |
| Affiliation |
AIIMS Mangalagiri, college of nursing |
| Address |
Room No:103.1st floor. College of nursing. AIIMS Mangalagiri. Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
6290734301 |
| Fax |
|
| Email |
paulnabeena@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of nursing, AIIMS Mangalagiri, Mangalagiri, Guntur, Postal code 522503 |
|
|
Primary Sponsor
|
| Name |
NABEENA PAUL |
| Address |
Room No: 005.Ground floor. Girls hostel. AIIMS Mangalagiri. Guntur |
| Type of Sponsor |
Other [self - funded] |
|
|
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 |
| DR MUTHUVENKATACHALAM S |
AIIMS Mangalagiri |
Surgical oncology department, 4th floor, C4, cubicle 7,8
General surgery, 4th floor, B4, cubicle 5 department.
IPD Block.
Guntur
ANDHRA PRADESH |
9410366146
muthu.venky@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE , AIIMS Mangalagiri |
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 |
No intervention |
Taking routine care |
| Intervention |
preoperative shoulder range of motion exercise(Flexion, Abduction, external rotation)
|
1.7 days before surgery
1.1Mode of delivery: Face-to-face demonstration by nurse investigator, shoulder ROM exercise include flexion, abduction, external rotation.
1.2Method of intervention:
Before admission
•Each participant in the intervention group will receive an individual demonstration and re-demonstration of the prescribed exercises.
•A seven-day exercise schedule logbook will be provided to every participant. They will be instructed to mark the logbook each time they complete the exercise protocol.
•To enhance compliance, the investigator will make a daily telephonic call to remind participants to perform the exercises as instructed.
•A written information leaflet and a short instructional video in the local language will also be provided to reinforce the exercise protocol after the initial demonstration.
1.3Exercise protocol:
•Exercises will be performed three times daily. Each shoulder range of motion (ROM) exercise will be repeated 20 times, requiring approximately five minutes to complete per session.
•Sequence of exercises:
1.Shoulder Flexion: 20 repetitions (45–60 seconds), followed by 60 seconds rest.
2.Shoulder Abduction: 20 repetitions (45–60 seconds), followed by 60 seconds rest.
3.External Rotation: 20 repetitions (45–60 seconds), followed by 60 seconds’ rest.
1.4Compliance:
Compliance will be assessed through the daily exercise logbook maintained by participants.
1.5 Management of Cancellations
•In cases where surgery is postponed, participants will be encouraged to continue performing the prescribed exercises until the revised surgery date.
•If surgery is permanently cancelled, the participant will be excluded from the study and replaced with the next eligible individual.
2. Continue for 7 days up to day before surgery-
2.1 Adherence check:
Adherence will be ensured through daily telephonic reminders and follow-up for seven consecutive days until the day before surgery.
After admission
1.5The investigator will monitor and document the compliance of each participant with the prescribed exercise schedule until surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Cancer patient scheduled to ALND.
2.Age of patients 18-70 yr.
3.patients physically able to participate in the exercise program.
4.Patients willing and able to provide informed consent to participate
5.Able to read or understand either English, Telugu or Hindi.
|
|
| ExclusionCriteria |
| Details |
1. Any contraindication to do exercise.
2. Individual with cognitive impairment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
post operative shoulder range of motion , post operative Pain
|
post operative shoulder range of motion(assess from third postop day to seventh postopday), post operative Pain (assess from third postop day to seventh postop day)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. acceptance of pre-operative exercise program
2. correlate the post operative shoulder range of motion with pain level. |
7 days preoperative exercise program and assess from third postop day to seventh postopday, |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
27/10/2025 |
| 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="0"
Months="6"
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 aims to find out whether doing simple shoulder exercises before surgery can help reduce pain and improve shoulder movement after Axillary Lymph Node Dissection (ALND). ALND is a common procedure in breast cancer and other cancers, but it often causes shoulder stiffness, pain, and limited movement after surgery. In this non-randomized control trial, patients undergoing ALND will be divided into two groups. The experimental group will perform nurse-directed shoulder exercises (flexion, abduction, and external rotation) for seven days before surgery, three times a day. The control group will receive routine pre-operative care only. After surgery, both groups will be assessed for shoulder range of motion and pain from the third to seventh post-operative day using a goniometer and a numerical pain rating scale. The study will be conducted at AIIMS Mangalagiri with 28 participants. The expected result is that patients who perform pre-operative exercises will have better shoulder movement and less pain compared to those who do not. This study may help establish a simple, cost-effective, nurse-led prehabilitation program to improve recovery and quality of life for cancer patients undergoing ALND. |