| CTRI Number |
CTRI/2024/07/071186 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing the efficacy of two different therapeutic interventions in post-mastectomy patients |
|
Scientific Title of Study
|
Efficacy of Upper Trunk Proprioceptive Neuromuscular Facilitation in comparison with Complex Decongestive Therapy in post mastectomy 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 |
Epshita kakati |
| Designation |
Post graduate student |
| Affiliation |
SGT University |
| Address |
SGT University
Faculty of Physiotherapy
Block D
Gurgaon,Haryana.
Gurgaon
HARYANA
122505
India |
| Phone |
9365004885 |
| Fax |
|
| Email |
epshitakakoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Rishi |
| Designation |
Associate Professor and Deputy Director at IQAC |
| Affiliation |
SGT University |
| Address |
SGT University
faculty of physiotherapy
gurgaon, haryana
SGT University
Internal Quality Assurance Cell (IQAC), 3rd floor
gurgaon, haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9365004885 |
| Fax |
|
| Email |
Priyanka.physio@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Epshita kakati |
| Designation |
Post graduate student |
| Affiliation |
SGT University |
| Address |
SGT University
faculty of physiotherapy
Block D
Gurgaon, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
9365004885 |
| Fax |
|
| Email |
epshitakakoti@gmail.com |
|
|
Source of Monetary or Material Support
|
| SGT University
Faculty of Physiotherapy
Gurgaon, Haryana
PIN CODE: 122505 |
|
|
Primary Sponsor
|
| Name |
Epshita kakati |
| Address |
khutikatia, kolongpar, near bhadraram rajkhowa L.P school P.O: Haiborgaon; DIST: Nagaon; STATE:Assam
PINCODE: 782002
|
| Type of Sponsor |
Other [self] |
|
|
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 Epshita kakati |
SGT University |
SGT University
Faculty of Physiotherapy
Block D, lower ground
Gurgaon, Haryana
122505
Gurgaon
HARYANA |
9365004885
epshitakakoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complex Decongestive therapy (CDT) |
The complex decongestive therapy is divided into 2 phases. They are as follows:
1.Volume reduction phase or intensive phase: comprised of manual lymphatic drainage for volume reduction, low stretch bandaging, exercises, and skin care
2.Volume stabilization or maintenance phase: comprised low stretch bandaging, exercises, skin care, and manual lymphatic drainage, if necessary
total duration: 4 weeks/ twice per week |
| Comparator Agent |
conventional training |
Aerobic training:
The exercise program will be divided into following parts:
1.warm up period
2.moderate intensity of aerobic exercises
3.cool down period
Respiratory muscle training: it will be done using inspiratory muscle training device.
Compressive bandaging: it will be done using low stretch bandages for providing compression to the affected arm.
total duration: 4 weeks/ twice per week
|
| Intervention |
Proprioceptive Neuromuscular Facilitation (PNF) |
The PNF exercises will be performed using 3 techniques:
1.Rhythmic initiation (RI) as warm-up exercises
2.Contract-relax
3.Hold-relax techniques
PNF pattern used: D1 pattern
total duration: 4 weeks/twice per week
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Female |
| Details |
1. Females with unilateral mastectomy for stage I and II breast cancer.
2. Females who have undergone mastectomy 1-3 years prior.
3. Females who have finished treatment i.e chemotherapy, radiotherapy
4. Females diagnosed with breast cancer-associated lymphedema.
5. Female who has undergone breast cancer surgery and experiencing discomfort at the surgical site, swelling in the afflicted limb, and heaviness in the affected limb.
6. Female who has experienced lymphedema with an increase of more than 3 cm compared to the opposite extremity.
7. Ability to walk without assistance at least 100 meters and no contraindications for participating in aerobic exercises.
|
|
| ExclusionCriteria |
| Details |
1. Females diagnosed with metastatic breast cancer.
2. Female anticipating breast reconstruction within the next six months.
3. Women with any medical conditions that could hinder their ability to engage in exercise, such as decompensated heart failure, unstable ischemic heart disease, severe untreated hypertension, moderate to severe chronic obstructive pulmonary disease, aortic aneurysm, or chronic respiratory insufficiency.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Universal Goniometer
Hand-held dynamometer
Anthropometric measurement using inch tape
Micro Respiratory Pressure Meter
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
DASH questionnaire
|
4 weeks |
| Harvard Step test |
4 weeks |
| WHOQOL- BREF questionnaire |
4 weeks |
| DASS-21 questionnaire |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2024 |
| Date of Study Completion (India) |
10/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
NEED OF THE STUDY: Despite
advancements in surgical techniques, many breast cancer survivors continue to
face physical and emotional challenges. In India, where breast cancer rates are
high, there is a critical lack of clinical data on therapies like
Proprioceptive Neuromuscular Facilitation (PNF) and Complex Decongestive
Therapy (CDT), necessitating research to establish standardized approaches for
improving arm function, aerobic capacity, quality of life, and psychological
well-being.
SIGNIFICANCE OF THE STUDY: This study
aims to address the needs of women undergoing mastectomy for breast cancer by
evaluating the effectiveness of Proprioceptive Neuromuscular Facilitation (PNF)
stretching and Complex Decongestive Therapy (CDT). These therapies have the
potential to improve flexibility, muscle function, and lymphatic activity,
thereby reducing lymphedema, enhancing upper extremity and respiratory
function, and improving overall quality of life. By filling gaps in existing
research, this study not only advances clinical practices but also informs
healthcare professionals and educates the community, leading to more
comprehensive and effective societal support for women undergoing mastectomy. |