| CTRI Number |
CTRI/2024/06/068339 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| 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 4 Weeks Of abdomen muscle engaging Breathing Exercise Compared To relaxing yoga Breathing On Diaphragm Mobility Pulmonary Function Inspiratory Muscle Strength And Functional Capacity Among Participants who are diagnosed with Breast Cancer An Experimental Study |
|
Scientific Title of Study
|
Effect Of 4 Weeks Of Pilates Breathing Exercise Compared To Pranayama On Diaphragm Mobility Pulmonary Function Inspiratory Muscle Strength And Functional Capacity Among Breast Cancer Patients An Experimental Study |
| 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 Simran Singh |
| Designation |
MPT First year Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
DVVPFs College Of Physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1
Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy
MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9834639928 |
| Fax |
|
| Email |
1506singhsimran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit D Diwate |
| Designation |
HOD Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
DVVPFs College Of Physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1
Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy
MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
08554990222 |
| Fax |
|
| Email |
abhijitdiwate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Singh |
| Designation |
MPT First year Cardiovascular and Respiratory Physiotherapy |
| Affiliation |
DVVPFs College Of Physiotherapy |
| Address |
Department of cardiovascular and respiratory physiotherapy Block 1
Basement DVVPFs college of physiotherapy Oppo Govt Milk Dairy
MIDC Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9834639928 |
| Fax |
|
| Email |
1506singhsimran@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFs College of Physiotherapy opp Govt milk dairy MIDC Ahmednagar,414111 |
|
|
Primary Sponsor
|
| Name |
DVVPFs College of Physiotherapy |
| Address |
DVVPFs College of Physiotherapy Oppo Govt Milk Dairy MIDC
Ahmednagar,414111 |
| Type of Sponsor |
Private medical college |
|
|
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 Simran Amarendra Singh |
DVVPFs college and hospital |
Department of
cardiovascular and
respiratory
physiotherapy Block 1
Basement DVVPFs
college of
physiotherapy Oppo
Govt Milk Dairy MIDC
Ahmednagar
Ahmadnagar
MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
9834639928
1506singhsimran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DVVPFs COPT Institutional Ethical Committee |
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 |
Pilates Breathing Exercise |
Pilates breathing exercise is for strengthen the Inspiratory Muscle Strength,and works of diaphragmatic muscle alspoengages the core muscle |
| Comparator Agent |
Pranayama |
pranayama is for relaxation and works on expiratory muscles,also helps for relaxing and calming the mind and also can be use as mindfulness breathing to reduce respiratory rate |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Age 40-64 years
2.Patient diagnosed with Breast Cancer.
3.Patients who are undergoing for adjuvant chemotherapy.
|
|
| ExclusionCriteria |
| Details |
1.Subject already diagnosed with any neuromuscular diseases, cardiac disease, pulmonary complication.
2.Patient who are operated for breast cancer.
3.Patients with any anatomical & physiological problems which will alter the outcome measures.
4.Any surgical condition which will enhance or suppress the outcome measures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Diaphragm mobility,
Pulmonary Function,
Vital Capacity,
Inspiratory Muscle Strength |
pre and post Assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Age |
pre and post Assessment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/07/2024 |
| 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) |
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 is to see the effect of pilates breathing compared to pranayama on patient with breast cancer who are not operated.30 patients diagnose with breast cancer undergoing chemotherapy will be recruited based on inclusion and exclusion criteria. After the recruitment the outcome measure such as Pulmonary Function Test, Diaphragm Mobility ,Inspiratory Muscle Strength ,and Functional Capacity will be taken as per and post assessment, pilates breathing exercise and pranayama will be given to patient for 4 weeks 3 times a week. |