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CTRI Number  CTRI/2025/07/090824 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
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   "Effect of an 8-Week Exercise and Abdominal Bracing Program on Reducing Abdominal Muscle Separation in First-Time Mothers" 
Scientific Title of Study   Impact of Early Abdominal Bracing with exercises on Diastasis Recti in Primiparous Women: A Eight-Week Intervention 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  Brinda Dcosta 
Designation  Assistant Professor 
Affiliation  KLE College of Physiotherapy  
Address  Department of Orthopedic Physiotherapy, KLE College of Physiotherapy, Near Kundgol cross, Kotagundhshi, Gabbur

Dharwad
KARNATAKA
580028
India 
Phone  9588442600  
Fax    
Email  drbrindad24@kledeemeduniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Brinda Dcosta 
Designation  Assistant Professor 
Affiliation  KLE College of Physiotherapy  
Address  Hubballi

Dharwad
KARNATAKA
580028
India 
Phone  9588442600  
Fax    
Email  drbrindad24@kledeemeduniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  Brinda Dcosta 
Designation  Assistant Professor 
Affiliation  KLE College of Physiotherapy  
Address  Department of Orthopedic Physiotherapy, KLE College of Physiotherapy, Near Kundgol cross, Kotagundhshi, Gabbur

Dharwad
KARNATAKA
580028
India 
Phone  9588442600  
Fax    
Email  drbrindad24@kledeemeduniversity.edu.in  
 
Source of Monetary or Material Support  
KLE Cooperative Hospital, Shree shakti Rd, opposite Apsara Theatre, New Hubli, Karnataka 580020 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 
Suma Prakashgouda Patil  KLE Cooperative Hospital   Physiotherapy OPD, KLE Cooperative Hospital, Shree shakti Rd, opposite Apsara Theatre, New Hubli, Karnataka 580020
Dharwad
KARNATAKA 		 8310212992

sumapatilkcpt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JGMM Medical College Institution Ethics Committie  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Abdominal Binder and BATER  Participants receive the same abdominal exercise protocol but with the use of an abdominal binder during the 8-week intervention. 
Intervention  Binder Augmented Therapeutic exercise for Postnatal Recovery (BATER)  Abdominal breathing Posterior Pelvic tilt Static abdominal exercise Head lifting in crook lying Bridging Heel slides Abdominal breathing Posterior Pelvic tilt Static abdominal exercise Head lifting in crook lying Bridging: Heel slides Lumbar rotation TA ACTIVATION Hamstring stretch Piriformis stretch  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Primigravidae
Puerperium
Early postnatal
Vaginal delivery
Primiparous women identified with greater than or equal to 2 finger width of IRD during routine postpartum physiotherapy care
 
 
ExclusionCriteria 
Details  Multi gravidae
Complication of pregnancy
Preeclampsia, Eclampsia
LSCS
Cardio respiratory conditions
Cancer
Any recent surgery
Abdominal hernia (non reducible)
Musculoskeletal complication (disc prolapse, disc bulge,)
Gestational diabetes mellites
Diagnosed Neurological conditions
Fracture/arthritis
Unable to follow instruction
Not willing to participate
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction of diastastis Recti   2 Points  
 
Secondary Outcome  
Outcome  TimePoints 
Compliance with the Exercise Protocol  2 Points  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/08/2025 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 This study aims to evaluate the efficacy of combining abdominal exercises with abdominal bracing in managing Diastasis Recti (DRA) among first-time mothers during the early postpartum period. Diastasis Recti is a common musculoskeletal complication experienced by pregnant and postpartum women, marked by the separation of the rectus abdominis muscles. The condition can affect core stability, posture, and quality of life. Its prevalence can be as high as 82 percent during pregnancy, with many cases persisting postpartum. Despite its frequency, effective clinical interventions remain limited, especially in resource-constrained settings. This Study will be conducted over eight months with an intervention period of eight weeks. A total of 60 primiparous women identified with an inter-recti distance (IRD) greater then or equal to 25 mm will be randomly assigned to two groups: Group A (exercise only) and Group B (exercise with abdominal binder). The sampling will be done using through  Computer Generated Randomization method. The study will record data at baseline, the 6th week, and the 8th week. The outcome measures include changes in inter-recti distance (IRD), assessed through finger width and caliper method. Statistical analysis will involve unpaired t-tests for between-group comparisons and paired t-tests for within-group comparisons. An Intention-to-Treat (ITT) analysis will handle participant dropout. 
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