| CTRI Number |
CTRI/2025/10/096045 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological Preventive |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Aerobic exercise program on knowledge, attitude, practice and blood pressure control among pregnant women at risk of pre-eclampsia. |
|
Scientific Title of Study
|
A study to evaluate the effectiveness of prenatal aerobic exercise program on knowledge, attitude,exercise practices and blood pressure control among pregnant women at risk of pre-eclampsia attending outpatient department of Obstetrics and Gynecology in a tertiary care hospital. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debashruti Bera |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 103,
College of Nursing,
AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
8334078841 |
| Fax |
|
| Email |
debashrutibera@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Danasu R |
| Designation |
Principal cum Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 414,
4th floor,
College of Nursing,
AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
8946093068 |
| Fax |
|
| Email |
drdanasu@aiimsmangalagiri.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Debashruti Bera |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Room no 103,
College of Nursing,
AIIMS Mangalagiri
Guntur ANDHRA PRADESH 522503 India |
| Phone |
8334078841 |
| Fax |
|
| Email |
debashrutibera@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing,
AIIMS Mangalagiri,
Mangalagiri,
Guntur,
Postal Code 522503 |
|
|
Primary Sponsor
|
| Name |
Debashruti Bera |
| Address |
Room no 103,
First Floor,
College of Nursing,
AIIMS Mangalagiri,
Guntur,
Andhra Pradesh,
Postal Code 522503 |
| 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 |
| Dr Danasu R |
AIIMS Mangalagiri. |
Room no 301,
Third Floor,
OBG OPD,
OPD Block Guntur ANDHRA PRADESH |
8946093068
drdanasu@aiimsmangalagiri.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Prenatal aerobic exercise program |
Administration of systematically designed, structured two session interventions, of which session one will be an educational session for 35 minutes to provide knowledge about the preeclampsia, benefits, safety, and recommended practices of aerobic exercise during pregnancy. It will be delivered through interactive lecture cum discussion with the help of audio-visual aids. Session two will be demonstration of selected aerobic exercises like side bends, hip circles, hamstring curls, tap and punch and shoulder press jerk for 25 minutes. The participants will be provided a information containing leaflet for further study. |
| Comparator Agent |
Treatment as usual(TAU) along with information containing leaflet. |
The participants will receive routine care and information containing leaflet. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women at risk of preeclampsia according to Gestosis score.
2.Pregnant women having gestational period more than 20 weeks and less than 28 weeks.
3.Pregnant women who are willing to participate in the study.
4.Pregnant women within the reproductive age group (age group of 18-49 years).
5.Pregnant women who are able to read, write and comprehend one language either English or Telugu.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women who have contraindication of aerobic exercise according to ACOG guidelines like hemodynamically significant heart disease, restrictive lung disease incompetent cervix/cerclage, multiple gestation at risk for premature labor, persistent 2nd or 3rd trimester bleeding, placenta previa after 26 weeks gestation, premature labor during the current pregnancy, ruptured membranes, pre-eclampsia/pregnancy-induced hypertension.
2.Pregnant women developing any obstetric complications or labor pain during the study period.
3.Pregnant women who are already doing exercise daily for more than 30 minutes per day including walking.
4.Pregnant women having cognitive impairment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge, Attitude, Practice, Control of Blood pressure |
Baseline (Day 1),Posttest Day (Day 30) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="58" Sample Size from India="58"
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)
|
10/11/2025 |
| 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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Pregnancy is characterized by significant physiological adaptations, and maladaptive changes can increase the risk of gestational hypertensive conditions like pre-eclampsia (PE) and gestational hypertension (GHTN), which are leading causes of maternal and fetal morbidity and mortality globally. While exercise during pregnancy is generally recommended and has shown benefits for weight management and reduced risk of gestational diabetes mellitus (GDM), there’s a need for more research on its specific effects on blood pressure in at-risk populations and the optimal exercise parameters. The study aims to address the underutilization of preventive measures and effective management strategies for pre-eclampsia in India, where it contributes to approximately 15-20% of maternal deaths. The proposed non-pharmacological intervention, prenatal aerobic exercise, titled “A study to evaluate the effectiveness of prenatal aerobic exercise program on knowledge, attitude, exercise practices and blood pressure control among pregnant women at risk of pre-eclampsia attending outpatient department of Obstetrics & Gynecology in a tertiary care hospital” can be effective in controlling blood pressure. This study will employ a quantitative research approach with an quasi-experimental design involving an experimental and a control group. The target population is pregnant women at risk of pre-eclampsia, with a sample size of 58 antenatal women (29 in each group) to be recruited from the outpatient department of Obstetrics & Gynecology at AIIMS Mangalagiri. Participants will be selected based on inclusion criteria such as gestational age between 20 to 28 weeks and Gestosis score 3 or more than 3. The intervention group will receive a systematically designed prenatal aerobic exercise program, including educational sessions for 35 minutes and demonstration of selected aerobic exercises like side bends, hip circles, hamstring curls, tap and punch, and shoulder press jerk for 25 minutes followed by providing information leaflet for further study. The control group will receive routine care and same information containing leaflet given to the interventional group. Data on knowledge, attitude, and blood pressure will be collected at baseline (Day 1) and the same data with data on practice of those selected aerobic exercise on Day 30. The data will be analyzed using descriptive and inferential statistics to find out if there are any significant differences in knowledge, attitude, practice, and blood pressure between the experimental and control groups, and an association of knowledge, attitude, and practice with selected sociodemographic variables. This research is expected to provide evidence-based recommendations for integrating prenatal aerobic exercise into routine care for high-risk pregnant women, potentially improving maternal and neonatal outcomes. |