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CTRI Number  CTRI/2024/04/066550 [Registered on: 30/04/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
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   Role of Integrative Breathing Therapy in restoring respiratory function in patients who underwent breast cancer surgery : 3 days follow up study. 
Scientific Title of Study   Effect of Integrative Breathing Therapy on pulmonary function, chest expansion and pain in post operative breast cancer surgery patients: A randomized controlled trial 
Trial Acronym  RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akshata Mane 
Designation  Postgraduate student 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, OPD-4, MGM Institute of Physiotherapy.

Aurangabad
MAHARASHTRA
431003
India 
Phone  9604339334  
Fax    
Email  akshatamanepg@mgmiop.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Dobhal 
Designation  Associate Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, OPD-4, MGM Institute of Physiotherapy.

Aurangabad
MAHARASHTRA
431003
India 
Phone  9923401079  
Fax    
Email  santoshdobhal@mgmiop.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Akshata Mane 
Designation  Postgraduate student 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, OPD-4, MGM Institute of Physiotherapy.

Aurangabad
MAHARASHTRA
431003
India 
Phone  9604339334  
Fax    
Email  akshatamanepg@mgmiop.edu.in  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy, N-6 CIDCO, Aurangabad 431003 MAHARASHTRA India. 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy 
Address  N-6 Cidco, Aurangabad 431003 MAHARASHTRA India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akshata Mane  MGM Medical College and Hospital  1. Female Surgery Ward-1 (ward no. 540) 2. Female Surgery Ward-2 (ward no. 520) 3. Female Surgery Ward-3 (ward no. 640), Department of Surgery
Aurangabad
MAHARASHTRA 		 9604339334

akshatamanepg@mgmiop.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy  Conventional Physiotherapy (Upper limb mobility exercises and diaphragmatic breathing exercise) will be given to post operative breast cancer surgery patients for three days. The patients will receive a single session of 30-40 minutes per day.  
Intervention  Integrative Breathing Therapy and Conventional Physiotherapy  Integrative Breathing Therapy (Diaphragm Proprioceptive Training and Facilitation of Diaphragm Doming) will be given along with conventional physiotherapy to post operative breast cancer surgery patients for three days. The patients will receive a single session of 30-40 minutes per day.  
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1) Age group: 35-55 years old females
2) Single-sided surgeries
3) Minimally invasive surgeries- lumpectomy, quadrantectomy, partial mastectomy and segmental mastectomy  
 
ExclusionCriteria 
Details  1) Unconscious patients
2) Recent abdomino-thoracic surgeries/ rib fractures
3) Patients diagnosed with pulmonary conditions
4) Patients who were taking drugs that could affect airway patency
5) Intubated patients
6) Patients who have received pre-operative chemotherapy and radiation therapy
7) Patients who have undergone radical mastectomy and simple mastectomy  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Pulmonary Function   Pulmonary function will be assessed using spirometry pre- and post- the intervention on the first and last day of the three days intervention period. 
 
Secondary Outcome  
Outcome  TimePoints 
Chest Expansion  Chest expansion will be assessed using measuring tape pre- & post-intervention on the first & last day of the three days intervention period.  
Pain   Pain will be assessed using Visual Analog Scale pre- & post-intervention on the first & last day of the three days intervention period. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 2 
Date of First Enrollment (India)   10/05/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [akshatamanepg@mgmiop.edu.in].

  6. For how long will this data be available start date provided 30-06-2025 and end date provided 31-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Patients who had undergone breast cancer surgery will be included in the study trial if they met the inclusion criteria. The written and oral consent of all patients will be taken, and procedure will be explained. Demographic data will be noted. Baseline data which include pulmonary function, chest expansion and pain will be assessed. The patients will be randomly divided into two study groups - intervention group and control group. The patients will receive intervention as per the group allocation for 3 days. The intervention group will receive Integrative Breathing Therapy in addition to the conventional physiotherapy whereas the control group will receive conventional physiotherapy only. Integrative Breathing Therapy includes diaphragmatic proprioceptive training and facilitation of diaphragm doming - 3-5 repetitions/3 sets each. Conventional Physiotherapy includes patient education, wand exercises, elbow winging, shoulder blade stretch, shoulder blade squeeze, Codman’s exercises, wall slide exercises and diaphragmatic breathing therapy - 5-7 repetitions each. All participants will be receiving one session of 30-40 minutes per day. Outcome measures will be assessed pre and post intervention on the first and third day of the intervention period. Statistical analysis of the collected data will be done. Conclusion will be established based on the obtained results of the study. 
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