About this trial
Some women who develop high blood pressure during pregnancy, such as gestational hypertension or preeclampsia, may continue to have slightly or moderately high blood pressure after giving birth. This can increase their risk of heart disease later in life. Managing blood pressure and adopting a healthy lifestyle after pregnancy could help lower this risk.
Right now, the investigators don't know much about how postpartum rehabilitation programs focused on heart and pregnancy-related health could help women with these conditions. However, a feasibility study suggests that exercise programs might help reduce blood pressure and encourage healthier lifestyles in these women.
In this study, the investigators are testing an 8-week exercise program to see how it affects blood pressure, fitness, and blood vessel health. The investigators will compare the results with a group of women who receive usual healthcare, which includes verbal advice on healthy living but no supervised exercise sessions.
This type of program, called cardio-obstetric rehabilitation, combines exercises for heart health with specialized care for women's health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
are 3 to 6 months postpartum, willing, and able to give informed consent for participation;
are more than 18 years old;
are able to access and use a computer, mobile phone and internet (for online sessions);
were diagnosed with GH (BP higher than 139/89 mmHg after 20 gestational weeks) or PE (BP higher than 139/89 mmHg and proteinuria after 20 gestational weeks) during pregnancy.
Disqualifiers
have chronic (pre-existing) hypertension (BP>139/89 mmHg pre-pregnancy, <20 weeks' gestation or after 6 weeks postpartum);
received antihypertensive drug therapy prior to pregnancy or after 6 weeks postpartum;
are taking beta-blockers for any reason;
participated in exercise activity programs regularly before 3-month postpartum (more than 2 hour of moderate-to-vigorous exercise per week);
Trial design
Parallel
Treatments tested in this trial
Postpartum Cardio-obstetric Rehabilitation Program
Other interventionThe intervention consists of an 8-week exercise and education program with a hybrid format (in person, virtual and pre-recorded sessions). The aerobic exercise intensity will progressively increase from 50 to 85% of Targeted Heart Rate Range (THRR), calculated for middle-aged women using the maximal heart rate (HR) estimated as 206 - (0.88 x age) . First and second weeks training will target an intensity of 50-65% THRR, third and fourth weeks will target 65 to 75% of THRR, fifth to seventh weeks will target 75 to 80%, and eighth week will target 85%. Participants will use Fitbit Charge-6 to monitor THRR during exercise sessions. Pelvic floor, body alignment/core stability, balance, and low back pain prevention exercises will be added to each in-person session and repeated during the online session. Participants from the intervention group will receive recommendations to progressively reach daily 10,000 steps throughout the intervention period.
Treatment groups
Trial outcomes
Primary outcomes
Office Blood Pressure
Resting office BP will be measured with the patient in the sitting position after 5 minutes at rest using a validated automated sphygmomanometer according to established practice guidelines . Three readings will be taken at intervals of 2 minutes.
24-hour Ambulatory Blood Pressure
24-hour Ambulatory Blood Pressure using OSCAR 2 equipment.
Secondary outcomes
Static Retinal Vascular Analysis
Retinal microvasculature imaging will be taken using Static Vessel Analyzer (SVA-T, Imedos) through non-invasive procedures described by Hanssen's team .
Peripheral artery stiffness - PWV
Peripheral artery stiffness will be measured using SphygmoCor XCEL system through pulse wave velocity (PWV) as described by Daskalopoulou's team.
Peripheral artery stiffness - PWA
The Sphygmocor XCEL system will be used to assess arterial stiffness through Pulse Wave Analysis (PWA), according to the instruction guidelines.
Physical capacity (6MWT)
Six-minute walk test will be performed following the protocol described by the American Thoracic Society.
Other outcomes
SF-36 Quality of Life Questionnaire (SF-36).
Health status will be evaluated based on: SF-36 Quality of Life Questionnaire (SF-36).
Patient Health Questionnaire-9 (PHQ-9)
Health status will be evaluated based on: Patient Health Questionnaire-9 (PHQ-9) for depression symptoms
Edinburgh Postnatal Depression Scale (EPDS).
Health status will be evaluated based on: Edinburgh Postnatal Depression Scale (EPDS).
Pittsburgh Sleep Quality Index (PSQI).
Health status will be evaluated based on: Pittsburgh Sleep Quality Index (PSQI).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead sponsor
McGill University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options: