Clinical trial NCT06920537: Postpartum CO Rehabilitation
Official title: Postpartum Cardio-obstetric Rehabilitation After Hypertensive Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gestational Hypertension
Preeclampsia (PE)
Keywords: postpartum rehabilitation
physical exercise
blood pressure
Pelvic Floor
gestational hypertension
pre-eclampsia
small vessels
endothelial function
Lead sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Office Blood Pressure
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: 24-hour Ambulatory Blood Pressure
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
Secondary outcomes:
measure: Static Retinal Vascular Analysis
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Peripheral artery stiffness - PWV
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Peripheral artery stiffness - PWA
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Physical capacity (6MWT)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Physical activity levels
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Body composition
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Timed Up and Go (TUG)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Handgrip strength
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Glucose
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Angiogenic and proliferative function of peripheral blood ECFCs
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Plasmatic levels of angiogenic factors - VEGF
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Heart rate variability
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Circulating Endothelial Cells (cEC) Function
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Total cholesterol
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Insuline
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: LDL cholesterol
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: HDL cholesterol
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Triglycerides
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Brain Natriuretic Peptide (NT-PRO-BNP)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: C-reactive protein (CRP)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Plasmatic levels of angiogenic factors - NO
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
Other outcomes:
measure: SF-36 Quality of Life Questionnaire (SF-36).
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Edinburgh Postnatal Depression Scale (EPDS).
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Pittsburgh Sleep Quality Index (PSQI).
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Pregnancy Physical Activity Questionnaire (PPAQ).
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Duke Activity Status Index (DASI)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: International Physical Activity Questionnaire (IPAQ).
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Pelvic Floor Distress Inventory (PFDI-20)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Urogenital Distress Inventory (UDI)
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
measure: Pelvic Floor Impact Questionnaire (PFIQ-7).
timeFrame: Baseline, immediately post-intervention, and 6-month post-intervention
Locations:
city: Montreal
country: Canada
facility: Hôpital du Sacre-Coer de Montréal - CIUSSS du Nord-de-l'Île-de-Montréal
state: Quebec
Study officials:
References:
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citation: Magee LA, Pels A, Helewa M, Rey E, von Dadelszen P; Canadian Hypertensive Disorders of Pregnancy (HDP) Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy. Pregnancy Hypertens. 2014 Apr;4(2):105-45. doi: 10.1016/j.preghy.2014.01.003. Epub 2014 Feb 25.
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citation: Davenport MH, Ruchat SM, Mottola MF, Davies GA, Poitras VJ, Gray CE, Garcia AJ, Barrowman N, Adamo KB, Duggan M, Barakat R, Chilibeck P, Fleming K, Forte M, Korolnek J, Nagpal T, Slater LG, Stirling D, Zehr L. 2019 Canadian Guideline for Physical Activity Throughout Pregnancy: Methodology. J Obstet Gynaecol Can. 2018 Nov;40(11):1468-1483. doi: 10.1016/j.jogc.2018.09.004. Epub 2018 Oct 18. No abstract available.
citation: Bellamy L, Casas JP, Hingorani AD, Williams DJ. Pre-eclampsia and risk of cardiovascular disease and cancer in later life: systematic review and meta-analysis. BMJ. 2007 Nov 10;335(7627):974. doi: 10.1136/bmj.39335.385301.BE. Epub 2007 Nov 1.
citation: Bertagnolli M, Nuyt AM, Thebaud B, Luu TM. Endothelial Progenitor Cells as Prognostic Markers of Preterm Birth-Associated Complications. Stem Cells Transl Med. 2017 Jan;6(1):7-13. doi: 10.5966/sctm.2016-0085. Epub 2016 Jul 27.