| CTRI Number |
CTRI/2025/07/091254 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of exercises on sleep quality of women during pregnancy |
|
Scientific Title of Study
|
Effect of Moderate intensity exercises on
sleep quality of women in Second and
Third trimester of pregnancy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ritu Deshpande |
| Designation |
MPT student |
| Affiliation |
Shri Dharmasthala Manjunatheswara University |
| Address |
OPD number 13 OBG Physiotherapy Department SDM College of Physiotherapy Manjushree nagar sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9739283808 |
| Fax |
|
| Email |
rituaddeshpande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ritu Deshpande |
| Designation |
MPT student |
| Affiliation |
Shri Dharmasthala Manjunatheswara University |
| Address |
OPD number 13 OBG Physiotherapy Department SDM College of Physiotherapy Manjushree nagar sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9739283808 |
| Fax |
|
| Email |
rituaddeshpande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Bhatbolan |
| Designation |
Associate professor and pg guide |
| Affiliation |
Shri Dharmasthala Manjunatheswara University |
| Address |
OPD number 13 OBG Physiotherapy Department SDM College of Physiotherapy Manjushree nagar sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9916067268 |
| Fax |
|
| Email |
shweta.bhatbolan@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| OPD no 13 SDM College of Physiotherapy Manjushree nagar sattur Dharwad 580009 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Ritu A Deshpande |
| Address |
SDM College of Physiotherapy SDM College of Medical Sciences And Hospital Manjushree Nagar sattur Dharwad 580009 |
| 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 |
| Ritu A Deshpande |
SDM college of Physiotherapy |
SDM college of Physiotherapy Manjushree nagar sattur Dharwad 580009
Dharwad
KARNATAKA |
9739283808
rituaddeshpande@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM College of Medical Sciences and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pregnant Women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 2 |
Then after 4 weeks of duration participants will be divided into two groups adherent and non-adherent based on the adherence to the exercise regime at the time of follow up and PSQI of both
the groups will be reassessed.
|
| Intervention |
Group one |
The identified participants and who consent for the study will be prescribed Moderate Intensity exercises to women with self-reported sleep disturbance by PSQI in Second and Third trimester of pregnancy for 4 weeks of duration
The protocol will emphasize mainly on: Incorporating proper sleep position Relaxation technique
Upper body stretches General body fitness Chair based exercises
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Women in their Second and Third trimester of pregnancy
2. Women with no known complications
3. Age of participants: 21 years to 35 years
4. Participants who are willing to give written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Age of participants above 35 years
2. Participants with any other medical condition which contradicts them from participating in physical activity
3. Participants not getting clearance to participate in physical activity as per PARmed X checklist
4. Women who are in first trimester of pregnancy
5. Women with known complications
6. Uncooperative patients
7.Women not planning their delivery in SDM Hospital |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pittsburg sleep quality index |
At baseline and after 4 weeks of Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Type of delivery, Karada scan of mother, APGAR score, Weight of the baby |
Karada of the mother at baseline and after 4 weeks of intervention , type of delivery, APGAR score , Weight of the baby after 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
12/09/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - The link will be generated after completion of data collection
- For how long will this data be available start date provided 10-07-2026 and end date provided 10-07-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Regular physical activity can improve overall sleep quality and lowers sleep latency. Furthermore, regular moderate-intensity physical activity has shown potential in treating sleep disorders such as insomnia. There is substantial evidence supporting the use of exercise as an effective nonpharmacological treatment option for disrupted sleep. Recent study, however, has found that poor sleep may contribute to low levels of physical activity, highlighting a strong bidirectional link between exercise and sleep. Moderate intensity exercises, in particular, can give a multitude of physiological and psychological maternal advantages while also helping to increase functional abilities over time. A pregnant woman can participate in a complete resistance training program safely if she follows the proper guidelines Further research is needed to determine the impact of physical exercises on sleep during Second and third trimester of pregnancy including type, mode, duration, intensity, and time. Aim of the study is to evaluate the effect of moderate intensity exercise on sleep quality of women in Second and Third trimester of pregnancy and secondary objective is to see the effects of moderate intensity exercise program on Maternal and fetal outcomes. |