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CTRI Number  CTRI/2025/07/091437 [Registered on: 22/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of Transverse Abdominis Muscle activation along With Breathing Maneuvers On Inter-Recti Distance In Post Natal Women With Diastasis Recti: 
Scientific Title of Study   Effectiveness of Transverse Abdominis Muscle activation along With Breathing Maneuvers On Inter-Recti Distance In Post Natal Women With Diastasis Recti: A Randomized Control Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEHA DESHPANDE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  D.Y.PATIL COLLEGE OF PHYSIOTHERAPY, PIMPRI, PUNE 
Address  D.Y. Patil College of Physiotherapy, Department of Community Based Rehabilitation, 4th Floor 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018

Pune
MAHARASHTRA
411018
India 
Phone  9561587022  
Fax    
Email  drkulkarni.neha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NEHA DESHPANDE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  D.Y.PATIL COLLEGE OF PHYSIOTHERAPY, PIMPRI, PUNE 
Address  D.Y. Patil College of Physiotherapy, Department of Community Based Rehabilitation, 4th Floor, 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018


MAHARASHTRA
411018
India 
Phone  9561587022  
Fax    
Email  drkulkarni.neha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NEHA DESHPANDE 
Designation  ASSOCIATE PROFESSOR 
Affiliation  D.Y.PATIL COLLEGE OF PHYSIOTHERAPY, PIMPRI, PUNE 
Address  D.Y. Patil College of Physiotherapy, Department of Community Based Rehabilitation, 4th Floor, 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018


MAHARASHTRA
411018
India 
Phone  9561587022  
Fax    
Email  drkulkarni.neha@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  NEHA DESHPANDE 
Address  190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 
Type of Sponsor  Other [Self] 
 
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 
NEHA DESHPANDE  Dr. D.Y.PATIL COLLEGE OF PHYSIOTHERAPY  Dr. D.Y. Patil College of Physiotherapy, 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA 
9561587022

drkulkarni.neha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Post Partum Females having Diastasis Recti Abdominis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional exercises for diastasis recti.  Conventional exercises such as abdominal binding, static abdominal exercises, pelvic bridging etc will be administered 
Intervention  Transverse Abdominis Muscle Activation along With Breathing Maneuvers  Different Core Muscles Strengthening Exercises along with breathing maneuvers will be administered. The recommended duration of exercise will be 3 days per week, for 8 weeks 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Primiparous and Multiparous women with Post natal period of 6weeks to 6 months. women with Normal vaginal delivery as well as Caesarean section. Women with Mild to severe Diastasis Recti, measured on digital caliper.
 
 
ExclusionCriteria 
Details  Women with obstetric complications which will preclude participating in exercise program. Women with chronic respiratory disorders. Women with recent musculoskeletal injuries. Women with spontaneous abortion, stillbirth or premature birth before gestation week 32. Women presenting with third- and fourth-degree perineal tears after vag¬inal delivery. Women with positive signs of nerve root compression and sensory deficit. Women practicing any other exercise program.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Inter-Recti Distance by Digital Caliper
2.Transverse Abdominis Muscle Thickness using Ultra sonographic Measurements
3.Diaphragm Excursion using Ultra sonographic Measurements 
Baseline and at the end of 8th week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   25/08/2025 
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="4"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 02-01-2027 and end date provided 02-12-2033?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Diastasis recti abdominis (DRA) refers to the separation between the rectus abdominis along the linea alba due to increased abdominal internal pressure, which commonly occurs during and after pregnancy. Martin Eriksson Crommert (2020) had interviewed patients about their experience living with diastasis recti, and he found out that many women reported that the increased IRD affected their daily lives and that they felt discomfort or painful sensations mostly from the belly, but also from the lumbopelvic region. Some used the words ‘muscle cramp’ to describe the sensation, whereas others thought it was a more diffuse sensation that was hard to describe. They expressed sadness because it hindered them from many everyday activities, such as lifting heavier loads, e.g. laundry baskets, or playing around with their children in such a way that they could get pushed in their bellies. Furthermore, many of the women, regardless of whether or not they experienced discomfort or pain, described a sensation of heaviness in their pelvic region or of their belly falling out, already at relatively low loads. Most of the women described that they had difficulties recruiting their abdominal muscles properly; they expressed that they did not ‘find’ them, leaving them with a sense of instability in the mid-section of the body. Among other things, the women described it like they lacked a centre, that they could not keep their belly together, that their mid-section was ‘dead’, and that they lacked support in the middle. Several women described that they constantly needed to think about activating their abdominal muscles in order to get at least some sense of stability since they experienced no automatic activation anymore. During daily activities and exercise, the body felt wobbly. During e.g. physical exercises, they preferred to use seated or lying positions due to the perceived lack of muscular control/stability in standing positions. Some women felt that an elastic belt gave them a positive sense of support, others did not. While diastasis recti itself doesn’t directly cause breathing problems, the condition can significantly impact breathing patterns by altering the way abdominal muscles engage, potentially leading to shallow breathing and making it harder to recover from a separation due to improper core engagement; essentially, the weakened abdominal muscles can affect the movement of diaphragm, which is crucial for breathing properly.  Persistent DRA can potentially lead to a range of symptoms and dysfunctions. These can manifest as altered trunk mechanics, impaired pelvic stability, and altered posture, which can make the lumbar spine and pelvis more susceptible to injury. That is why diagnosing and treating Diastasis Recti at earliest and will help in improving the quality of life of post natal women. This study hypothesize that Strengthening core muscles along with breathing maneuver will improve Inter-recti Distance among post natal women. 


 
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