| CTRI Number |
CTRI/2024/07/071100 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| 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
|
To compare the effectiveness of Plank Exercise with Traditional Core Exercise in women After Delivery to increase quality of life. |
|
Scientific Title of Study
|
The Effectiveness of Plank Exercises Versus Traditional Supine Core Stability Exercise In Quality of Life In Women With Postpartum Diastasis of Recti - Abdominis: A Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhumi Davara |
| Designation |
Post Graduation Student |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences. |
| Address |
Room no. 4, Department Of Physiotherapy, North Block, Basement, Shri Mahant Indiresh Hospital, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
6359379383 |
| Fax |
|
| Email |
bhoomidavara2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Tabassum Azmi |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences. |
| Address |
Room no. 4, Department Of Physiotherapy, North Block, Basement, Shri Mahant Indiresh Hospital, Dehradun
Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
drtabassumazm22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Tabassum Azmi |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical Sciences and Allied Health Sciences. |
| Address |
Room no. 4, Department Of Physiotherapy, North Block, Basement, Shri Mahant Indiresh Hospital, Dehradun
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
drtabassumazm22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Guru Ram Rai University, School Of Paramedical And Allied Sciences, Pathribagh, Dehradun-248001 |
|
|
Primary Sponsor
|
| Name |
Bhumi Davara |
| Address |
Room no. 4, Department Of Physiotherapy, Shri Guru Ram Rai University, School of Paramedical and Allied Sciences, Pathribag, Dehradun-248001 |
| 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 |
| DR TABASSUM AZMI |
Shri Mahan Indiresh Hospital |
Shri Mahant Indriresh Hospital Department of of Physiotherapy North block, Basement, Dehardun
Dehradun
UTTARANCHAL |
9340473424
drtabassumazm22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE (IEC) SHRI GURU RAM RAIO INSTITUTE OF MEDICAL AND HEALTH SCIENCE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94-O9A||Other obstetric conditions, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Plank Exercise in postpartum women with diastasis recti |
Each subjects will receive the treatment for 3dayper week/6 weeks.
duration will be 50 minutes and rest for 5-7 minutes in between each set.
treatment include:
Fore arm Plank, Hand Plank, Knee Plank, Plank with Hip Dip
Maintain and hold this position for 10 seconds while core engage |
| Comparator Agent |
Traditional Supine Core Stability Exercise in Postpartum women with Diastasis Recti |
Each subjects will receive Traditional Supine core stability exercise include Bridging, Supine Abdominal Crunch, Supine Posterior Pelvic Tilt, Russian Twist, A Kegel.
duration will be 50 minutes for 3 times per week for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
patient have vaginal and caesarean section delivery or 3 month to 3 year postpartum period and BMI under or equal to 29kg/m2 and distance between rectus abdominis is more than 2.5 cm. |
|
| ExclusionCriteria |
| Details |
Patient who have participated in postpartum gymnastics and other physical activity or have cardiac and respiratory problems or have pelvic and abdominal surgery or have neurological disease or bowel/ bladder trauma during delivery. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Digital Nylon Caliper |
1st day,21st day,42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Two Finger Width Palpation Test
|
1st day,21st day,42nd day |
| Pelvis Floor Distress Inventory |
1st day,21st day,42nd day |
| WHO Quality of life scale |
1st day,21st day,42nd day |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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
|
Diastasis Recti Abdominis Term used for Increased inter rectus abdominis muscle because of so many reasons but mainly after pregnancy, During Pregnancy rectus abdominis muscle stretch out in order to make space for growing fetus, This condition lead after multiple deliveries in postpartum women. Therefore Physiotherapy play major beneficial role in Diastasis recti. Plank exercise are renowned for their effectiveness in strengthening core muscles, They involve maintaining a position similar to a push up but with body weight supported on the forearms, elbows and tows. Planks engage multiple muscle groups and improve endurance throughout the core. Core stability exercises aims to improve the body’s ability to control and stabilize movements, focusing on deep core muscles and back muscles. By enhancing core stability- core stability exercises like Bridging, Russian Twist, A Kegel, Supine abdominal crunch, Supine posterior pelvic tilt these exercises can help alleviate symptoms of diastasis recti and reduce the risk of related complications. |