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CTRI Number  CTRI/2026/03/106951 [Registered on: 27/03/2026] Trial Registered Prospectively
Last Modified On: 26/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Can Regular Exercise Improve Sleep, Stress, Anxiety, and Quality of Life in Mothers After Childbirth? 
Scientific Title of Study   Efficacy of structured exercise regimen on sleep quality, perceived stress, body image, quality of life, and anxiety in postpartum depression (PPD) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ritika Saini 
Designation  PG Student (MPT-Neurology) 
Affiliation  SGT University, Gurugram 
Address  75-B,Rail Nagar, Nirman Nagar, Kings Road , Jaipur , Rajasthan, India

Jaipur
RAJASTHAN
302019
India 
Phone  9116402789  
Fax    
Email  ritikasaini68545@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Himanshu Gakhar 
Designation  Assistant Professor, Faculty of Physiotherapy 
Affiliation  SGT University, Gurugram 
Address  SGT University,Budhera, Gurugram-Badli Road, Haryana, India

Gurgaon
HARYANA
122505
India 
Phone  9871863033  
Fax    
Email  himanshu.gakhar_fphy@sgtuniversity.org  
 
Details of Contact Person
Public Query  
Name  Ritika Saini 
Designation  PG Student (MPT-Neurology) 
Affiliation  SGT University, Gurugram 
Address  75-B,Rail Nagar, Nirman Nagar, Kings Road , Jaipur , Rajasthan, India

Jaipur
RAJASTHAN
302019
India 
Phone  9116402789  
Fax    
Email  ritikasaini68545@gmail.com  
 
Source of Monetary or Material Support  
SGT University, Gurgaon - Badli Road, Chandu, Budhera, Gurugram, Haryana 122505 
 
Primary Sponsor  
Name  SGT University 
Address  SGT University, Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ritika Saini PT  Obstetrics and Gynaecology OPD, SGT Hospital  SGT University, Budhera, Gurugram, Haryana
Gurgaon
HARYANA 		 9116402789

ritikasaini68545@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Faculty of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  Education,counselling, role of exercise,precaution and usual care  
Intervention  MOMCORE Protocol  This work presents a structured, evidence-informed multimodal rehabilitation protocol for postpartum women aimed at improving pelvic floor function, core stability, sleep quality, and psychological well-being. The protocol integrates diaphragmatic breathing, pelvic floor activation, mobility, strengthening, relaxation, and functional exercises. It is designed as a 4-week intervention, performed 30 minutes per session, 5 days per week, and incorporates validated outcome measures to ensure clinical applicability and reproducibility. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1. A diagnosis of depression according to ICD-10, confirmed through screening with the
EPDS at 10-14 and 12–16 weeks, and the CIS-R at 13–17 weeks postpartum. Women
with a combined diagnosis of anxiety and depression are also eligible.
2. Currently inactive (defined as engaging in less than 150 minutes of moderate-intensity
physical activity per week, as recommended by current public health guidelines, during
the past 7 days).
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3. Women in the postpartum period (4 to 38 weeks) who are experiencing symptoms of
postpartum depression (PPD).
4. Had no history of current alcohol or substance abuse.  
 
ExclusionCriteria 
Details  1. Engaging in more than 60 minutes of exercise per week.
2. Pregnant at the time of initial assessment.
3. Pre –existing hypertension or diabetes
4. Currently receiving antidepressant medication
5. Musculoskeletal issues that could hinder participation in exercise.
6. Exercise induced asthma. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
sleep quality
perceived stress
body image
anxiety 		 baseline, 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1)quality of life
2)relationship between physical activity and mental well-being 		 baseline, 4 weeks 
 
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)   07/04/2026 
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="1"
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   This study aims to evaluate the effectiveness of a structured exercise regimen on sleep quality perceived stress body image quality of life and anxiety in women with postpartum depression. Postpartum depression is a common mental health condition that affects women after childbirth and can negatively influence both maternal wellbeing and mother child bonding. The study uses an experimental pre and post test control group design. Participants will be divided into an exercise group and a control group receiving usual care. The intervention consists of a structured exercise program for four weeks. Outcomes will be measured using standardized tools. The findings may support exercise as a safe cost effective and non pharmacological approach for improving physical and psychological health in postpartum women. 
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