| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|
|
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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 |
|
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Secondary Outcome
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- 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.
- 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. |