| CTRI Number |
CTRI/2024/06/069651 [Registered on: 28/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the effect of Physiotherapy Program (Education and Structure Exercise Program) which benefit the pregnant women. |
|
Scientific Title of Study
|
Efficacy of Physiotherapy interventions - Education and structured exercise program to optimize postural alignment and muscle balance of lumbo-pelvic hip complex on physical performance in pregnant women.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijaya Bagade |
| Designation |
Professor |
| Affiliation |
St Andrews college of Physiotherapy |
| Address |
St. andrews College of Physiotherapy,Manjari Phata, Indraprashtha Society, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9890481166 |
| Fax |
|
| Email |
vijayabagade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaya Bagade |
| Designation |
Professor |
| Affiliation |
St Andrews college of Physiotherapy |
| Address |
St. andrews College of Physiotherapy,Manjari Phata, Indraprashtha Society, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9890481166 |
| Fax |
|
| Email |
vijayabagade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijaya Bagade |
| Designation |
Professor |
| Affiliation |
St Andrews college of Physiotherapy |
| Address |
St. andrews College of Physiotherapy,Manjari Phata, Indraprashtha Society, Hadapsar, Pune, Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9890481166 |
| Fax |
|
| Email |
vijayabagade@gmail.com |
|
|
Source of Monetary or Material Support
|
| St. Andrews college Of Physiotherapy, Pune 411028,Mharashtra, India |
|
|
Primary Sponsor
|
| Name |
St Andrews College of Physiotherapy |
| Address |
Manjari Phata, Indraprashtha Society, Hadapsar, Pune, Maharashtra 411028 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Vijaya Bagade |
St. Andrews College of Physotherapy |
Physiotherapy OPD , Ground Floor Manjari Phata, Indraprashtha Society, Hadapsar, Pune
Pune
MAHARASHTRA |
9890481166
vijayabagade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, St. Andrews college of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant women |
| Patients |
(1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
controlled group |
exercises will not be given to this group. Participants are instructed to do their routine activities |
| Intervention |
Structure exercise program |
1.Education and Posture correction exercises
2.Activation of core muscles
a. Activation of transvers abdominus
b. Activation of multifidus with transvers abdominus
c. Activation of pelvic floor muscles.
3. Posterior pelvic tilt exercise
4. Bridging exercises
This is to activate hip extensor that is glutei muscle
5. Mini squat with wall support
To strengthen hip and knee muscles
6.Hip clams
7.Side way walking for 20 feets
To strengthen the abductor of hip
8. Backward walking for 20 feets
9.Forward walking for 5 minutes twice or thrice in day
10. 5 minutes relaxation
45 minutes a session, 6 sessions a week between 3rd to 9th months of pregnancy |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. 3 months pregnant females
2. Females without back pain 3. Primigravida
|
|
| ExclusionCriteria |
| Details |
1. Any neurological condition
2. Females with back pain
3. Other back conditions PIVD, lysthesis
4. Any inflammatory and infective conditions.
5. Multigravida
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Performance
i. 6 minute walk test
ii. Figure of 8 walking test:
iii. Chair Rise test:
|
1. end of 3rd month of pregnancy
2.end of 5th month of pregnancy
3. end of 7th month of Pregnancy
4. post one month of delivery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pregnancy-Related Anxiety questionnaire
2. General self-efficacy Scale
|
1. end of 3rd month of pregnancy
2.end of 5th month of pregnancy
3. end of 7th month of Pregnancy
4. post one month of delivery
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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 Applicable |
| 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 study design
is Randomized controlled trial involving pregnant women. The Participants will
be randomly divided in to two groups as experimental and control group.
Experimental group receives intervention in the form of activation of core
muscles, general mobility exercises and posture correction. The control group
participants receives routine activities. The outcome measures used were 6
minute walk test, chair raise test and figure of eight walking. These outcome
measures were captured at 3rd month, 5th month and 7th month during pregnancy
and 1 month post-delivery. The purpose of the study is to design clinical
guidelines for exercises during pregnancy. The Study is going to be conducted
in India. The recruitment is not yet started. It’s planned to be started from
1st of July 2024. The attempt of publications will start after the completion
of statistical analysis. |