| CTRI Number |
CTRI/2025/02/080958 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of four Weeks Exercise Programme on Cardiorespiratory Endurance, Body Composition, Muscle Endurance and Quality of Life in Post partum Women: A Pre-Post Experimental Study |
|
Scientific Title of Study
|
The Effect of Four Weeks Exercise Programme on Cardiorespiratory Endurance, Body Composition, Muscle Endurance and Quality of Life in Post-Partum Women: A Pre-Post Experimental 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 |
Nainita Rane |
| Designation |
Student |
| Affiliation |
Goa Medical college |
| Address |
Faculty block,
Physiotherapy department,
Department of orthopaedic Goa Medical College ,Tiswadi,Bambolim Goa.
403202
Faculty block,
Physiotherapy department,
Department of orthopaedic,Goa medical College tiswadi bambolim goa
North Goa
GOA
403202
India |
| Phone |
7057685917 |
| Fax |
|
| Email |
nainita.rane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jorida Fernandes |
| Designation |
Associate Professor in Physiotherapy |
| Affiliation |
goa medical college |
| Address |
Faculty block,
Physiotherapy department,
Department of orthopaedic,
Goa Medical College,Tiswadi Bambolim Goa.
Faculty block,
Physiotherapy department,
Department of orthopaedics,
Goa medical College
Tiswadi bambolim goa
North Goa
GOA
403202
India |
| Phone |
9060778888 |
| Fax |
|
| Email |
jorida.fernandes@goa.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Jorida Fernandes |
| Designation |
Associate Professor in Physiotherapy |
| Affiliation |
goa medical college |
| Address |
Faculty block, physiotherapy department
Department of orthopaedic,Goa Medical College,Tiswadi Bambolim Goa.
Faculty block, physiotherapy department,
Department of orthopaedic Goa medical College tiswadi bambolim goa
North Goa
GOA
403202
India |
| Phone |
9060778888 |
| Fax |
|
| Email |
jorida.fernandes@goa.gov.in |
|
|
Source of Monetary or Material Support
|
| Goa Medical College, tiswadi Bambolim,Goa-India
403202 |
|
|
Primary Sponsor
|
| Name |
Nainita Rane |
| Address |
Faculty block, physiotherapy department, Department of orthopaedic,Goa Medical College Tiswadi, Bambolim India
403202 |
| 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 |
| nainita rane |
Goa Medical College |
Department of obstetrics and gynaecology,Goa Medical College ,Tiswadi-Bambolim ,Goa,India
North Goa
GOA |
7057685917
nainita.rane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOA MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Post partum exercises programme |
4 weeks of Exercise program consist of warm up, low impact cardio respiratory training, neuromotor training, strength training, stretching exercises, training and relaxation techniques followed by cool down. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. All participants who have undergone vaginal delivery.
2. All participants with day2 to 6 weeks between age group of 18 to 45 years.
3. Primigravida and multigravida post-partum women
4. Participants clearing Physical Activity Readiness Questionnaire score of zero and Fatigue Assessment Questionnaire score of less than twenty two and Roland -Morris Low Back Pain & Disability Questionnaire score of less than ten.
5. Participants willing to sign informed consent
|
|
| ExclusionCriteria |
| Details |
1. Medical contraindication like Hypertension, Type I and II Diabetes mellitus, Cardiac conditions like unstable angina, heart failure, stroke.
2. Other conditions like systemic illness or infection, postpartum anaemia, postpartum haemorrhage, placenta Previa, preeclampsia.
3. Diastasis recti with more than 5cm.
4. Women who have not exercise during pregnancy.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cardio respiratory using 6MWT |
It will be measured at baseline and after 4 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Muscular endurance
|
30 sec chair stand tests
|
| Flexibility |
V- sit reach test in cm |
| Body composition by using Omron hbf 214 |
calculate Fat mass % ,Muscle mass (kg) |
| Waist -hip ratio |
calculate waist hip ratio by using measuring tape |
| Quality of life using Rand SF scale |
assess change in QoL score after 4 weeks. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2025 |
| 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="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
|
It is a experimental study on effect of 4 week exercises programme on cardiorespiratory endurance ,body composition and quality of life in Post partum women.By promoting postpartum exercise, communities can potentially reduce healthcare costs associated with obesity, chronic diseases, can contribute to safer communities by enhancing physical strength, coordination, and mobility. |