| CTRI Number |
CTRI/2020/12/029870 [Registered on: 17/12/2020] Trial Registered Prospectively |
| Last Modified On: |
15/12/2020 |
| 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
|
Effect of abdominal hypopressive exercise on sexual dysfunction and pelvic floor muscle strength in parous women |
|
Scientific Title of Study
|
Effect of abdominal hypopressive exercise on pelvic floor muscle strength and sexual dysfunction in parous women: A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rekha Prajapati |
| Designation |
PG student |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
OBG DEPARTMENT of Physiotherapy NO.28 DR.PRABHAKAR KORE HOSPITAL
JNMC Campus Nehru nagar BELAGAVI
OBG DEPARTMENT of Physiotherapy NO.28 DR.PRABHAKAR KORE HOSPITAL
JNMC Campus Nehru nagar BELAGAVI
Belgaum
KARNATAKA
590010
India |
| Phone |
8867006537 |
| Fax |
|
| Email |
raykhaprazapati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrArati Mahishale |
| Designation |
Professor |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
OBG DEPARTMENT of Physiotherapy NO.28 DR.PRABHAKAR KORE HOSPITAL
JNMC Campus Nehru nagar BELAGAVI JNMC Campus Nehru nagar BELAGAVI
OBG DEPARTMENT of Physiotherapy NO.28 DR.PRABHAKAR KORE HOSPITAL
JNMC Campus Nehru nagar BELAGAVI JNMC Campus Nehru nagar BELAGAVI
Belgaum
KARNATAKA
590010
India |
| Phone |
96322822622 |
| Fax |
|
| Email |
mphysioarati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rekha Prajapati |
| Designation |
PG student |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
OBG DEPARTMENT of Physiotherapy NO.28 DR.PRABHAKAR KORE HOSPITAL
JNMC Campus Nehru nagar BELAGAVI JNMC Campus Nehru nagar BELAGAVI
OBG DEPARTMENT of Physiotherapy NO.28 DR.PRABHAKAR KORE HOSPITAL
JNMC Campus Nehru nagar BELAGAVI JNMC Campus Nehru nagar BELAGAVI
Belgaum
KARNATAKA
590010
India |
| Phone |
8867006537 |
| Fax |
|
| Email |
raykhaprazapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| OBG DEPARTMENT of Physiotherapy NO.28 DR.PRABHAKAR KORE HOSPITAL
JNMC Campus Nehru nagar BELAGAVI JNMC Campus Nehru nagar BELAGAVI |
|
|
Primary Sponsor
|
| Name |
Rekha Prajapati |
| Address |
JNMC NEHRU NAGAR BELGAUM |
| 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 |
| Rekha Prajapati |
OBG DEPARTMENT of Physiotherapy NO.28 DR.PRABHAKAR KORE HOSPITAL |
JNMC Campus Nehru nagar BELAGAVI JNMC Campus Nehru nagar BELAGAVI
Belgaum
KARNATAKA |
8867006537
raykhaprazapati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KLE institute if physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N899||Noninflammatory disorder of vagina, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abdominal hypopressive exercise |
abdominal hypopressive exrecise was proposed by Marcel Caufriez. These exercises lead to pelvic floor toning, abdominal wall toning and normalization of tension structures and muscle aponeurotic antagonists. It will be given in crook lying, sitting and standing postion for 10 secs hold and 10 repetition in each position once a day. |
| Comparator Agent |
pelvic floor muscle training |
pelvic floor muscle training is described by kegel and was the first to repots its benefits achieving the gold standard denomination.
It will be given in crook lying postion, sitting and standing postion for 10 sec hold and 10 repetition in each position once a day. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parous women between 25 to 40 years
Female sexual function index questionnaire score is equal to or less than 23.6 out of 30
Pelvic organ prolapse grade 1 and 2
Subjects Willing to participate |
|
| ExclusionCriteria |
| Details |
Pregnant women
Presence of cognitive impairment
Neurological conditions or degenerative diseases that could interfere muscle activation
Pelvic organ prolapse garde 3 and 4
Active urinary tract infection |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Oxford scale for pelvic floor muscle
Female sexual function index |
Baseline and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
25/12/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There will be 2 groups . One group will receive pelvic floor muscle training whereas other group will receive abdominal hypopressive exercise and pelvic floor muscle training. Both group will receive the intervention for a duration of 35 to 40 mins for 2 months. Pre and post intervention individuals will be assessed for pelvic floor muscle strength and they will be asked to fill female sexual function index questionnaire. |