Postpartum CO Rehabilitation

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Status: Not yet enrolling

Conditions: Gestational Hypertension; Preeclampsia (PE)

Treatments: Other: Postpartum Cardio-obstetric Rehabilitation Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06920537

MP-32-2025-2963

Details and patient eligibility

About

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.

Full description

Women with severe hypertensive disorders during pregnancy, such as preeclampsia (PE), have a higher risk of heart disease and stroke within five to 10 years of their pregnancy. Because their blood pressure (BP) drops in the postpartum period in comparison to the values they had during pregnancy, the hypertensive disorder can be considered resolved. However, recent studies have shown that their postpartum BP may be higher than before pregnancy. Hypertensive pregnancy has been associated with endothelial and microvascular dysfunction and capillary rarefaction, which could be the key mechanism leading to elevated BP in the postpartum period. Studies have shown that physical exercise promotes BP reduction, stimulates angiogenesis and improves microcirculation in healthy subjects, but also in patients with cardiovascular and metabolic diseases. Therefore, interventions to better monitor BP combined with a healthy lifestyle could help reduce the risk of heart disease in later years. The effects of postpartum cardio-obstetric rehabilitation in women with gestational hypertension (GH) or PE are still unknown. It is of interest to determine whether a postpartum cardio-obstetric rehabilitation program could reduce BP, identifying the possible mechanisms, and stimulate the adoption of a healthy lifestyle with potential long-term health benefits for women.

The main objective of this study is to describe the effects of an 8-week rehabilitation program combining aerobic exercise with obstetric rehabilitation starting between 3 to 6 months postpartum on BP changes, vascular structure and physical activity levels, which could lead to long term health benefits compared to usual care in women with previous GH and PE. The 8-week rehabilitation program will include cardiac (aerobic exercise) and obstetric (pelvic floor training, core and balance) exercises, as well as online education courses about healthy lifestyle. The outcomes will be compared with participants submitted to the usual care in the postpartum. At the end of the study participation period, participants of the control group will be offered to participate in the intervention program (crossing study).

The following outcomes will be evaluated, before and immediately after the intervention: ambulatory and 24-hour BP, arterial stiffness, pulse wave velocity, static retinal vessels analysis, body composition (including body mass index), physical capacity (6-minute walk test), physical activity level (number of daily steps), lipid and glucose profiles, quality of life (SF-36), as well as plasmatic angiogenic biomarkers and the angiogenic function of circulating endothelial cells. Moreover, 6-months post-intervention, participants will be submitted again only to physical evaluation to assess the long-term effects of the intervention program.

Cardio-obstetric rehabilitation is a new field, lacking the description and evaluation of effective programs. The investigators expect that the results obtained from this study will contribute to the design of a patient-oriented rehabilitation program. Our findings will provide the first evidence to support postpartum rehabilitation services in clinics which in turn could lead to long term health benefits to women.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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);
• have any musculoskeletal injury that can limit or contraindicate the practice of exercise;
• have any major contraindications to exercise such as cardiomyopathy, cardiac arrhythmias and conduction abnormalities or congenital heart disease.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Rehabilitation Group

Experimental group

Description:

The rehabilitation Group will be submitted to an 8-week exercise and education program with a hybrid format, delivered by a professional physiotherapist at the Centre Jean-Jacques Gauthier (CJJG). Briefly, one in-person session (60 minutes of aerobic exercise and full-body strength exercise), one online session (30-35 minutes - focus on pelvic floor muscle training, core/abdominals, balance, and stretching exercises), and one pre-recorded video (30 minutes - exercise instructions) will be delivered per week. Participants will use Fitbit Charge-6 to progressively reach daily 10,000 steps throughout the intervention period. Four online educational workshops on healthy lifestyle will be delivered.

Treatment:

Other: Postpartum Cardio-obstetric Rehabilitation Program

Control group

No Intervention group

Description:

Control group participants will received the usual care, together with information about the guidelines for physical activity practice, nutritional and risk factor monitoring instructions, pelvic floor exercise instructions, and recommendations to progressively reach daily 10,000 steps according to guidelines . Participants will also receive a Fitbit device.