| CTRI Number |
CTRI/2024/04/065994 [Registered on: 19/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Effect of pelvic floor muscle training in women with abdominal gap(Diastasis recti) |
|
Scientific Title of Study
|
Effectiveness of pelvic floor muscle training in women with Diastasis recti using digital method |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Pooja |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Sri Ramachandra Faculty Of Physiotherapy ,Sri Ramachandra medical college ,Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9790778633 |
| Fax |
|
| Email |
pooja02.diya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J Pooja |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute Of Higher Education and Research |
| Address |
Sri Ramachandra Faculty Of Physiotherapy ,Sri Ramachandra medical college ,Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai.
Chennai
TAMIL NADU
600116
India |
| Phone |
9790778633 |
| Fax |
|
| Email |
pooja02.diya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Ponmathi P |
| Designation |
Assistant professor |
| Affiliation |
Sri ramachandra institute of higher education and research |
| Address |
Sri Ramachandra Faculty Of Physiotherapy ,Sri Ramachandra medical college ,Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri ramachandra institute of higher education and research |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Self funding] |
|
|
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 J POOJA |
Sri ramachandra institute of higher education and research |
Sri Ramachandra Faculty Of Physiotherapy ,Sri Ramachandra medical college ,Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai
Chennai
TAMIL NADU |
9790778633
pooja02.diya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diastasis recti |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Abdominal exercise |
The exercise program consisted of three simple exercises for duration of 16 WEEKS,which combined a long exhalation and the given movement. Each repetition lasted 10 seconds and was performed 10 times. The starting position was supine lying with lower limbs bent in the hip and knee joints. The frst exercise consisted of CURL UP . The second exercise consisted of TRANSVERSE ABDOMINAL CONTRACTION along with CURL UP . The last exercise consisted of TRANSVERSE ABDOMINAL CONTRACTION with SLR with a long calm exhalation. This exercise was repeated 10 times for each lower limb. |
| Intervention |
Pelvic floor muscle training |
The exercise program consisted of three simple exercises for period duration of 16 weeks, which combined a long exhalation and the given movement. Each repetition lasted 10 seconds and was performed 10 times. The starting position was supine lying with lower limbs bent in the hip and knee joints. The first exercise consisted of CURL UP + PFM . The second exercise consisted of TRANSVERSE ABDOMINAL CONTRACTION with CURL UP + PFM . The last exercise consisted of TRANSVERSE ABDOMINIS CONTRACTION with SLR + PFM with a long calm exhalation. This exercise was repeated 10 times for each lower limb. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Primi and multi para
Women with DR postpartum
BMI under or equal to 29kg/m2
Diastasis recti more than 2.5 cm
Assisted vaginal breech, or instrumental delivery
Early (3 weeks) postpartum period |
|
| ExclusionCriteria |
| Details |
Spinal disorders or lower limb deformities that might hinder the abdominal exercises.
Presence of chronic mental illness/ postpartum depression
Third and fourth degree perineal tears after vaginal delivery
Women having their child delivered by caesarean section /Previous cesarean section
Women suffering from any heart or respiratory condition, including excessive coughing or sneezing
Serious illness to mother or child
Any pelvic /abdominal or back surgery
multiple pregnancies pregnancy-related complications such as polyhydramnios, fetal macrosomia, diabetes, or hypertension; abdominal skin diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Finger width method
|
Pre and post intervention values of 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Digital calliper |
Pre & post intervention values of 16 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
29/04/2024 |
| 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="0"
Months="6"
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
|
Women with Diastasis recti volunteering for this study from the obstetrics and gynaecology ward of ramachandra hospital have been taken for this Study . The participants are randomized into 2 groups and experimental group and a control group . Women’s are recruited based on the inclusion and exclusion criteria.Intervention group The first part was a 20-minute posture position . For women after childbirth, was recommended laying in prone. Cushions were placed under their abdomen such that lumbar lordosis was neutralized . The second part of the program consisted of three simple exercises which combined a long exhalation and the given movement. Each repetition lasted 10 seconds and was performed 10 times. The starting position was supine lying with lower limbs bent in the hip and knee joints. The first exercise consisted of curl up + PFM . The second exercise consisted of TRANSVERSE ABDOMINAL CONTRACTION with CURL UP + PFM . The last exercise consisted of TRANSVERSE ABDOMINAL CONTRACTION with SLR + PFM with a long calm exhalation. This exercise was repeated 10 times for each lower limb. The third part of the program was educational and focused on preventing further increasing of the DRAM. The education included: getting out of bed, sitting, breastfeeding and lifting the baby. Control group: The first part was a 20-minute posture position . For women after childbirth, was recommended laying in prone. Cushions were placed under their abdomen such that lumbar lordosis was neutralized. The second part of the program consisted of three simple exercises which combined a long exhalation and the given movement. Each repetition lasted 10 seconds and was performed 10 times. The starting position was supine lying with lower limbs bent in the hip and knee joints. The frst exercise consisted of CURL UP . The second exercise consisted of TRANSVERSE ABDOMINAL CONTRACTION along with CURL UP . The last exercise consisted of TRANSVERSE ABDOMINAL CONTRACTION with SLR with a long calm exhalation. This exercise was repeated 10 times for each lower limb. The third part of the program was educational and focused on preventing further increasing of the DRAM. The education included: getting out of bed, sitting, breastfeeding and lifting the baby. |