| CTRI Number |
CTRI/2023/01/049186 [Registered on: 24/01/2023] Trial Registered Prospectively |
| Last Modified On: |
20/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of scapular and shoulder muscle exercises in preventing arm lymphedema among the breast cancer surgery patients |
|
Scientific Title of Study
|
Effect of Scapular and Shoulder Muscle Exercises in Preventing Secondary Lymphedema Following Breast Cancer Surgery – A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahalakshmi V |
| Designation |
Physiotherapist Grade II |
| Affiliation |
Dr TN MGR Medical University Government of Tamil Nadu |
| Address |
Room number 12
Department of Physiotherapy
Government Hospital
Madukkarai
Coimbatore
Coimbatore
TAMIL NADU
641105
India |
| Phone |
9865056677 |
| Fax |
|
| Email |
mahas_v@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Ramamoorthy |
| Designation |
Professor and HOD |
| Affiliation |
Dr TN MGR Medical University |
| Address |
Room number 171
Department of Physical medicine and Rehabilitation
PSG Hospitals
Peelamedu
Coimbatore
Coimbatore
TAMIL NADU
641004
India |
| Phone |
9994735506 |
| Fax |
|
| Email |
ramamoorthy@psgimsr.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Mahalakshmi V |
| Designation |
Physiotherapist Grade II |
| Affiliation |
Dr TN MGR Medical University Government of Tamil Nadu |
| Address |
Room number 12
Department of Physiotherapy
Government Hospital
Madukkarai
Coimbatore
Coimbatore
TAMIL NADU
641105
India |
| Phone |
9865056677 |
| Fax |
|
| Email |
mahas_v@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PSG Hospitals
Peelamedu
Coimbatore 641004 |
|
|
Primary Sponsor
|
| Name |
VMahalakshmi Principal investigator |
| Address |
Physiotherapist Grade II
Governmment Hospital
Madukkarai
Coimbatore 641105 |
| Type of Sponsor |
Other [Seif] |
|
|
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 |
| V Mahalakshmi |
PSG Institute of Oncology , PSG Hospitals |
Room number 40
PSG Institute of Oncology
Peelamedu
Coimbatore 641004
Coimbatore
TAMIL NADU |
9865056677
mahas_v@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC PSG institute of Medical sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Along with Conventional physiotherapy, Scapular and Shoulder muscle
strengthening exercises are taught |
EXERCISE PRESCRIPTION EXPERIMENTAL GROUP
1. Conventional Physiotherapy
2. SCAPULAR AND SHOULDER EXERCISES
Warm ups: 3 – 5 repetitions
1. Scapular squeezes
2. Shoulder circles
Stretches: 3 – 5 repetitions with hold for 15 - 20 seconds
1. Butterfly stretch
2. Overhead clasped hands stretch
3. Chest stretch
4. Full body stretch
5. Cat camel
Strengthening exercises
1. Shouder internal and external rotation
2. Shoulder rowing
3. Pull over
4. Back fly
5. V raise
6. Wall push ups
7. Pelvic bridging
8. Biceps curl
STRENGTHENING EXERCISES
10 repetition; 1 set ; 4th to 9th week POD (Weight: 1/2 litre water bottle)
10 repetitions: 2 sets; 10th to 15th week POD (Weight: 750ml water bottle)
10 repetitions: 3 sets; 16th week POD onwards till 6 months (Weight: 1 litre water bottle)
|
| Comparator Agent |
Control conventional physiotherapy
|
EXERCISE PRESCRIPTION
CONTROL GROUP
PRE OPERATIVE
Diaphragmatic breathing exercises
Demonstration of shoulder range of motion exercises
POST OPERATIVE
10 repetition; 1 set till in hospital
10 repetition; 2 sets after discharge till the end of 6 months
1. Diaphragmatic breathing exercises
2. Shoulder range of motion exercises
3. Hand ball squeezes
4. Bed mobility exercises
5. Shoulder shrug
6. Transcutaneous Electrical Nerve Stimulator if VAS more than 5
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1 Modified Radical Mastectomy with ALND
2 Breast conservation surgery with ALND
3 Unilateral surgery
4 Neo adjuvant chemotherapy
5 Adjunct Chemotherapy and radiation following surgery
6 First surgery for invasive Breast cancer
7 Patients under Chief Ministers Comprehensive Health Insurance Scheme will be included for our study
8 Patients who agree to be monitored through video call
9 Willingness of patient to participate in the study
|
|
| ExclusionCriteria |
| Details |
1 Platelet count < 75,000/ul
2 Hb level < 8%
3 Cardiac Patients [Cardiovascular instability / cardiovascular symptoms at low workloads(<3 metabolic equivalents [METs])]
4 Impaired cognition
5 Patient unable to understand English or Tamil
6 Marked orthopedic and/or musculoskeletal limitations
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Arm circumference in centimeters
Volumetry in millimeters
Muscle strength in kilograms
Shoulder range of motion in degrees
Shoulder pain and disability index in percentage |
preoperative measurement
Assessment
After 3 weeks
After 6 weeks
After 9 weeks
After 12 weeks
Afafter 20 weeks
16 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life score higher the score greater the quality of life |
Baseline preoperative
second post operative day
After 4 weeks
7 weeks
10 weeks
13 weeks
16 weeks
20 weeks |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
25/01/2023 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, single blinded, parallel group trial comparing the conventional treatment and scapular and shoulder muscle strengthening exercises in preventing arm lymphoedema among the patients who have undergone breast cancer surgery. The study has been planned to conduct for a duration of 10 months. The outcome measures being arm circumference, arm volumetry, muscle strength, shoulder range of motion, shoulder pain and disability, quality of life using inch tape, volumeter, baseline push pull dynamometer, goniometer, SPADI and FACT B questionnaire. It is expected that strengthening exercises will prevent arm lymphedema. |