| CTRI Number |
CTRI/2024/05/066765 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
29/04/2024 |
| 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
|
A Comparative Study on Effect of pelvic floor exercises and diaphragmatic activation versus split tummy exercise program on improving Outcome Measures such as inter-recti distance, strength and quality of life in participants of Post-partum women having diastasis recti |
|
Scientific Title of Study
|
Effect of Pelvic Floor Exercises and Diaphragmatic Activation v/s Split Tummy Exercises on Inter-Recti Distance, Strength and Quality of life in Diastasis Recti:A Comparative 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 |
Vaishnavi Chawake |
| Designation |
Junior Resident |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha.
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
8830297335 |
| Fax |
|
| Email |
vaishnavichawake25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Lashkari |
| Designation |
Professor community health physiotherapy department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Community Health Physiotherapy Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha.
Department of Community Health Physiotherapy,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422865300 |
| Fax |
|
| Email |
drravilashkari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ravi Lashkari |
| Designation |
Professor Community Health Physiotherapy Department |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha.
Department of Community Health Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422865300 |
| Fax |
|
| Email |
drravilashkari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha-442001. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Vaishnavi Chawake |
Acharya Vinobha Bhave Rural Hospital |
OPD Department of community health physiotherapy and department of obsteric and gynaecology ward and OPD, Acharya Vinobha Bhave Rural Hospital,Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe), Wardha.
Wardha
MAHARASHTRA |
8830297335
vaishnavichawake25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta meghe institute of higher education and research (D.U.). |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P968||Other specified conditions originating in the perinatal period, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pelvic Floor Exercises with Abdominal Activation |
The patients in the first group A underwent aerobic training and pelvic floor exercises combining with abdominal activation having 4 weeks of rehabilitation. Week 1 Pelvic floor muscle contraction Supine lying position Maximal contractions for 6 sec followed by 3 fast contractions followed by 6 sec rest 10 repetitions 1 set Week 2 Pelvic floor muscle contraction Kneeling position Maximal contractions for 10 sec followed by 5 fast contractions followed by 10 sec rest 10 repetitions 1set Week 3 Pelvic floor muscle contractions Sitting position Maximal contractions for 10 sec followed by 5 fast contractions followed by 10 sec rest Add weighted vaginal coned 15 repetitions 1 set Week 4 Pelvic floor muscle contraction Standing position Maximal contractions for 15 sec followed by 10 fast contractions with added weighted vaginal cones followed by 15 sec rest 10 repetitions 1 set The Intervention will be given for 4 weeks. Along with pelvic floor this group was also instructed about how to perform Diaphragmatic aspiration (DA): a slow diaphragmatic inspiration, followed to a total expiration followed by gradual contraction of the TrA and intercostal muscles with the rise of the hemidiaphragm (diaphragmatic aspiration). Thus, were taught about how to contract the PFM at the same time of diaphragmatic aspiration in lying positions. In four week intervention program aerobic traning has also been given. |
| Intervention |
Slipt Tummy Exercise Program |
Group included 30 participants in it and having 4 weeks of rehabilitation. The baseline findings of all the participants were recorded by using digital caliper which measured diastasis recti, sphygmomanometer for strength for Measuring abdominal muscle strength, Visual analogue scale (VAS) which measured pain, Posterior pelvic pain provocation test which assessed lumbopelvic instability. Before starting the intervention, each woman was given the consent forms which were filled by them and prior to this procedure participants were guided by the therapist about the way to fill the consent form and the entire procedure was explained to the participant by the therapist. Once the baseline readings or findings were obtained by the assessor under the guidance of Professor, they were noted in a data collection sheet. This group B also given Aerobic training and split tummy exercise program:
The STEP module consists of three phases, facilitation, integration, and strengthening of abdominal muscles, to be implemented during postpartum, at a minimum frequency of 3 times a week involving at least three sets at 10 repetitions each. No specific time frame or regression of exercises in case the participant was unable to perform the proposed exercises, were given. The exercises focused on abdominal muscle strengthening with crunches, planks, and Russian twists.
For the crunch exercise, participants were asked to lift their head and focus both eyes between both thighs while in a supine position, with both legs bent.
For the plank exercise, participants were required to lie down using the support of both elbows and to hold the position as long as possible.
Finally, to complete a Russian twist, the participant had to sit back slightly while keeping her spine straight and both legs bent and then turning the body to the right and left.
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 25 to 40 years
2. Multipara (two or more deliveries)
3. Full term normal delivery
4. Up to 6 weeks postpartum
|
|
| ExclusionCriteria |
| Details |
Female with previous history of abdominal surgeries
Female with BMI less than 40 kilogram
Subjects suffering from any heart or respiratory condition
Any injury or fracture to back or fracture of Vertebra
Any neurological problem having cognitive impairment that impended their comprehension of instructions. |
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Digital Calliper
2. Posterior pelvic pain provocation test.
3. Visual Analogue Scale
4. Sphygmomanometer
5. Health-Related Quality of Life Scale (HRQOL) |
Baseline and After 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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 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
|
The aim of the study is to evaluate effect of pelvic floor exercises and diaphragmatic activation versus split tummy exercises on inter-recti distance, strength and quality of life in diastasis recti in postpartum women. |