| CTRI Number |
CTRI/2022/05/042930 [Registered on: 31/05/2022] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
EFFECT OF STRUCTURED PHYSICAL THERAPY INTERVENTION VERSUS CONVENTIONAL THERAPY IN PATIENTS WITH MODIFIED RADICAL MASTECTOMY |
|
Scientific Title of Study
|
EFFECTIVENESS OF STRUCTURED PHYSICAL THERAPY INTERVENTION VERSUS CONVENTIONAL THERAPY ON SHOULDER DYSFUNCTION, QUALITY OF LIFE AND FATIGUE LEVEL IN PATIENTS WITH MODIFIED RADICAL MASTECTOMY IN A RURAL SETUP- A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ADITI PRAMOD KHOT PhD Scholar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY |
| Address |
DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, DEPARTMENT OF COMMUNITY PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI.TAL: RAHATA, DISTRICT: AHMEDNAGAR MAHARASHTRA, PINCODE: 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9130210294 |
| Fax |
|
| Email |
aditik212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MRS VAISHALI PHALKE |
| Designation |
PROFESSOR |
| Affiliation |
DR. BALASHAHEB VIKHE PATIL RURAL MEDICAL COLLEGE |
| Address |
DR. BALASAHEB VIKHEPATIL RURAL MEDICAL COLLEGE, DEPARTMENT OF COMMUNITY MEDICINE, PRAVARA INSTITUTE OF MEDICAL SCIENCES, TAL: RAHATA, DISTRICT: AHMEDNAGAR, LONI. MAHARASHTRA PIN: 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9822840790 |
| Fax |
|
| Email |
vaiphalke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ADITI PRAMOD KHOT PhD Scholar |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY |
| Address |
DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, DEPARTMENT OF COMMUNITY PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI.TAL: RAHATA, DISTRICT: AHMEDNAGAR MAHARASHTRA, PINCODE: 413736
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9130210294 |
| Fax |
|
| Email |
aditik212@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY |
| Address |
DR. APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY, DEPARTMENT OF COMMUNITY PHYSIOTHERAPY, PRAVARA INSTITUTE OF MEDICAL SCIENCES, LONI.TAL: RAHATA, DISTRICT: AHMEDNAGAR MAHARASHTRA, PINCODE: 413736 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ADITI PRAMOD KHOT |
DR. APJ ABUL KALAM COLLEGE OF PHYSIOTHERAPY |
HALL NO. 404, DEPARTMENT OF COMMUNITY PHYSIOTHERAPY,LONI.TAL: RAHATA, DISTRICT: AHMEDNAGAR MAHARASHTRA, PINCODE: 413736
Ahmadnagar
MAHARASHTRA |
9130210294
aditik212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Day 1 to Week 1
1. Wound Prevention and Edema Control -
2. Breathing Exercises 3 times/day, 2 sets- 10 breaths/set. Progression in week 2 with Breath hold
a. Pursed Lip Breathing
b. Diaphragmatic Breathing
3. Active Assisted Range of Motion Exercises for Shoulder, Elbow and wrist (within pain free range) 10 repetitions/set for 2 times/day
Week 3 – Week 4
Thoracic Expansion Exercises 8 – 10 repetitions, 2 sets for 3 times/day.
Incentive Spirometry 10 repetitions, 2 sets for 3 times/day.
Active Range of Motion Exercises for Shoulder, Elbow and Wrist 10 repetitions/set for 2 times/day
Week 5 – Week 6
Incentive Spirometry with Breath hold 10 repetitions, 2 sets for 3 times/day.
Active Range of Motion Exercises for Shoulder, Elbow and Wrist 10 repetitions/set for 2 times/day
|
| Intervention |
Experimental Group |
Day 1 to Week 2
Breathing Exercises – Pursed Lip Breathing and Diaphragmatic Breathing – 4-5 times/day each 2 sets with 10 breaths/set, Progression in week 2 Pursed Lip Breathing and Diaphragmatic Breathing with breath hold.
Active assisted exercise for shoulder, elbow and wrist – 10 repetitions/set for 2 times / day (Flexion, Extension, Abduction, Adduction)
To improve blood circulation and decrease swelling Ball Squeezing exercise for hand 2-3 times/day – 10 repetitions/set of 2 set
Shoulder Shrugs 10 repetitions/set for 2 times/day
Aerobic Exercise:
Warm up and cool down for 3 mins (Neck Movements, Shoulder Shrugs, Forearm stretch, Trapezius Stretch)
For Day1-2 – Bed Side Walking
Day 2-5 – Walking within the Ward
Day 5-14 – Brisk Walking with Intensity of 50-60% HR max for 20 mins
Avoid Sleeping on Affected arm to avoid pressure on sutures
Prevention of Edema – Raise affected arm above level of heart for 45 mins 2-3 times/day
Week 3 to Week 4
Thoracic Expansion Exercise 8-10 repetitions for 2-3 times/day
Incentive Spirometry 2-3 times a day, 2 sets with 10 times per set
AROM Exercises for Shoulder with wand 10-12 rep for 2-3 times/day
Strengthening exercises for Shoulder, Elbow and wrist with TheraBand at 60% of 1 RM, 2 set of 8 – 12 repetitions
Aerobic Exercises:
Warm up and cool down for 3 mins (Neck Movements, Shoulder Shrugs, Forearm stretch, Trapezius Stretch)
Static Cycling for 20 mins at 60-65% HR max for 3-5 days/week
Week 5 to Week 6
Incentive Spirometry with breath hold 2-3 times/day, 3 sets with 10 repetitions/set
Strengthening Exercise with Resistance Band at 60-70% of 1RM, 3 sets of 12-15 repetitions. Progression with Free Weights at 60-70% of 1RM, 3 sets of 12-15 repetitions.
Aerobic Exercise: Treadmill Training at 65-70% HR max
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Women more than 18 years age
Clinically diagnosed with breast cancer according to imaging and pathological examination.
Surgical treatment of breast includes modified radical mastectomy, Mastectomy, or conservation surgery.
Pain VAS score more than 1
Patient willing to participate and giving informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients with severe deformity, any trauma or diseases affecting muscles and joints such as Rheumatoid Arthritis, skin grafting on or around the shoulder.
Previous chronic illness such as diabetes, osteoporosis, renal failure, heart disease.
Neurological dysfunction.
Patients undergone Recent Shoulder surgery
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shoulder Range of Motion
strength
pain
Quality of Life
Fatigue Level
|
The data will be collected at baseline, 2 week, 4 week, 6 week and follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Endurance -6 MWT
2. BMI
3. Body fat % Omron HBF-375 Body Composition Monitor
|
The data will be collected at baseline, 2 week, 4 week, 6 week and follow up |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/06/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
STUDY
CONDUCT
All the patient
satisfying above inclusion and exclusion criteria will undergo randomization
allocated in anyone group and further grouped as Experimental and Control
Group.
RANDOMIZATION
All the patients
will be allocated as per the simple randomization method (lottery method) to
any of the above group patient.
Procedure
The Ethical Committee approval will be taken from
Institutional Ethical Committee of Pravara Institute of Medial Sciences (DU),
Loni. The participants taken will be Post operative Breast Cancer patients
(Modified Radical Mastectomy) from Surgery Department referred to Community
Physiotherapy Department. The participants will be screened on basis of
inclusion and exclusion criteria. Participants will be explained about the
purpose and nature of the study, benefits of intervention, risk involved in the
study, duration of the study etc. in the language best understood by the
participants. The participants will be encouraged to clarify queries regarding
the study, if any. An informed consent will be obtained from all the
participants in accordance with procedures approved by the Institutional
Ethical Committee.
The demographic data will be obtained and a detailed
assessment of patients will be done on basis of name, age, height, weight, BMI,
present chief complaints, past history, medical and surgical history.
A total of 100 participants will be randomly grouped
into 2 groups by using simple random sampling (lottery method).
Experimental Group:
Patients will be treated with Physical therapy intervention consisting of Range
of Motion, Breathing, Stretching, Mobility, Flexibility Exercises, Ambulation
and Aerobic Exercise.
Control Group:
Patients will be instructed about Wound Prevention, Breathing Exercises and
Active Range of Motion Exercises.
The
outcome measures via, ROM, Strength, QoL, Fatigue and endurance level will be
recorded after 2,4, 6 weeks exercise protocol and patients will be followed up.
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