Postpartum Cardio-obstetric Rehabilitation After Hypertensive Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Office Blood Pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research team that will evaluate the participants will be blind to the group - intervention or control (conventional care).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Office Blood Pressure
时间窗: Baseline, immediately post-intervention, and 6-month post-intervention
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
时间窗: Baseline, immediately post-intervention, and 6-month post-intervention
24-hour Ambulatory Blood Pressure using OSCAR 2 equipment.
次要结局
- Insuline(Baseline, immediately post-intervention, and 6-month post-intervention)
- Static Retinal Vascular Analysis(Baseline, immediately post-intervention, and 6-month post-intervention)
- Peripheral artery stiffness - PWV(Baseline, immediately post-intervention, and 6-month post-intervention)
- Peripheral artery stiffness - PWA(Baseline, immediately post-intervention, and 6-month post-intervention)
- Physical capacity (6MWT)(Baseline, immediately post-intervention, and 6-month post-intervention)
- Physical activity levels(Baseline, immediately post-intervention, and 6-month post-intervention)
- Body composition(Baseline, immediately post-intervention, and 6-month post-intervention)
- Timed Up and Go (TUG)(Baseline, immediately post-intervention, and 6-month post-intervention)
- Handgrip strength(Baseline, immediately post-intervention, and 6-month post-intervention)
- Glucose(Baseline, immediately post-intervention, and 6-month post-intervention)
- Angiogenic and proliferative function of peripheral blood ECFCs(Baseline, immediately post-intervention, and 6-month post-intervention)
- Plasmatic levels of angiogenic factors - VEGF(Baseline, immediately post-intervention, and 6-month post-intervention)
- Heart rate variability(Baseline, immediately post-intervention, and 6-month post-intervention)
- Circulating Endothelial Cells (cEC) Function(Baseline, immediately post-intervention, and 6-month post-intervention)
- Total cholesterol(Baseline, immediately post-intervention, and 6-month post-intervention)
- Glycated hemoglobin (HbA1c)(Baseline, immediately post-intervention, and 6-month post-intervention)
- LDL cholesterol(Baseline, immediately post-intervention, and 6-month post-intervention)
- HDL cholesterol(Baseline, immediately post-intervention, and 6-month post-intervention)
- Triglycerides(Baseline, immediately post-intervention, and 6-month post-intervention)
- Brain Natriuretic Peptide (NT-PRO-BNP)(Baseline, immediately post-intervention, and 6-month post-intervention)
- C-reactive protein (CRP)(Baseline, immediately post-intervention, and 6-month post-intervention)
- Plasmatic levels of angiogenic factors - NO(Baseline, immediately post-intervention, and 6-month post-intervention)
研究者
Mariane Bertagnolli
Assistant Professor, Scientist
McGill University