| CTRI Number |
CTRI/2024/11/077415 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
09/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Exercise Impact on Weight, Waist-Hip Ratio, and Depression in Postpartum Women: RCT |
|
Scientific Title of Study
|
Effect of Exercise Regimen in Postpartum Females on
Weight, Waist Hip Ratio and Depression: Randomized
Control Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gargi Joshi |
| Designation |
Intern |
| Affiliation |
Dr D Y Patil College of Physiotherapy |
| Address |
Room number 3 3rd floor Cardiology department Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9021485170 |
| Fax |
|
| Email |
gargiij28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayuri Shah |
| Designation |
Faculty |
| Affiliation |
Dr D Y Patil College of Physiotherapy |
| Address |
Room number 3 3rd floor Cardiology department Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8087861628 |
| Fax |
|
| Email |
mayuri.shah@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayuri Shah |
| Designation |
Faculty |
| Affiliation |
Dr D Y Patil College of Physiotherapy |
| Address |
Room number 3 3rd floor Cardiology department Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar Pune
MAHARASHTRA
411018
India |
| Phone |
8087861628 |
| Fax |
|
| Email |
mayuri.shah@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune 411018. India |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil College of Physiotherapy |
| Address |
Room number 3 3rd floor cardiology department Dr D Y Patil college of Physiotherapy, Sant Tukaram Nagar, Pimpri, Pune 411018. India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Gargi Joshi |
Dr D Y PATIL COLLEGE OF PHYSIOTHERAPY |
Room number 3 3rd floor Cardiology department Dr D Y Patil college of Physiotherapy Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
9021485170
gargiij28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DY Patil Vidyapeeth |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Postpartum Females |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of Exercise Regimen |
exercises modified for postpartum females will be given for 6 weeks 3 times a week. the intensity of exercises will increase as the weeks progress |
| Comparator Agent |
EFFECT OF EXERCISE REGIMEN IN POSTPARTUM FEMALES ON WEIGHT, WAIST HIP RATIO AND DEPRESSION: RANDOMIZED CONTROL TRIAL |
Participant is asked to Brisk walk for 6 weeks, 3 times a week. in the end of 6 weeks the results will be compared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Post-partum females post 1month to 12 months
Females with Full term normal delivery Multiple deliveries as well as single delivery |
|
| ExclusionCriteria |
| Details |
Participants not willing
Participants with co morbidities like diabetes mellitus, hypertension,
hypotension, hyperthyroidism, hypothyroidism Participant with addictions like tobacco chewing, alcohol and cigarette smoking |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Weight
Waist hip ratio
Edinburgh depression scale |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BMI |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/12/2024 |
| Date of Study Completion (India) |
19/02/2025 |
| Date of First Enrollment (Global) |
09/12/2024 |
| Date of Study Completion (Global) |
19/02/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 term postpartum can be defined as the period following the birth of a child, which includes
physical and emotional recovery of the mother as well as the adjustment to the new role of
parenthood[1]. The amount of weight gained during pregnancy can significantly impact both
immediate and long-term health of the mother and her infant. According to the Institute of
Medicine (IOM), recommended weight gain during pregnancy varies based on the mother’s pre
pregnancy Body Mass Index (BMI):
ï‚· Underweight (BMI < 18.5): 12.7 to 18 kg
 Normal weight (BMI 18.5–24.9): 11.3 to 15.9 kg
 Overweight (BMI 25–29.9): 6.8 to 11.3 kg
 Obese (BMI ≥ 30): 5 to 9 kg
This weight gain is distributed across various body areas, reflecting the changes that support fetal
growth and prepare the body for childbirth. This weight gain is prominently seen in abdomen,
thighs, waist, arms and breasts [1,2]. It usually takes several months to a year to shed gestational
weight after delivery. Factors like diet, exercise, breastfeeding, physical activity and individual
metabolism all influence the rate of weight loss.
A study by AIIMS found that 5.6% of rural women experience postpartum depression or anxiety,
which impacted on their parenting stress and relationships. This mental health challenge is
largely influenced by societal norms, which increase the struggles faced by these women,
reflecting deep-rooted societal attitudes towards motherhood and mental health[3]. Despite the
availability of postnatal classes, many women still do not attend them. Traditional Indian
postpartum dietary habits often include foods like ghee and jaggery, aimed at enhancing milk
production and recovery. However, these practices may not fully align with the Medical Council
of India’s guidelines, which suggest a balanced diet rich in fruits, vegetables, lean proteins, and
whole grains to meet needful nutritional needs.
When factors such as limited support, traditional dietary practices, and insufficient nutritional
guidance combined, can contribute to postpartum depression[3].
The stress and anxiety associated with this mental health challenge often extend beyond
individual well-being, often affect marital relationships and sex life. Strain in partners may be
experienced due to the emotional and physical toll of postpartum depression, which leads to
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decreased intimacy and communication problems. Furthermore, traditional diets high in calorie
dense foods like ghee and jaggery can lead to obesity, which has long-term consequences on
health like obesity, mental health issues and chronic conditions [4].
Obesity increases the risk of chronic conditions such as diabetes, cardiovascular disease, and
hypertension, all of which can further impact a person’s quality of life, overall health, and
relationship dynamics [4]. Addressing these issues through both mental health support and
balanced nutrition, is crucial for improving both immediate and long-term well-being. Along
with these methods daily Physiotherapy can show some definite results. |