Gestational HypertensionNCT06920537
Postpartum CO Rehabilitation
A study testing Postpartum Cardio-obstetric Rehabilitation Program in people with Gestational Hypertension and Preeclampsia (PE), run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Hypertension, Preeclampsia (PE)
- What is being tested?
- Postpartum Cardio-obstetric Rehabilitation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mariane Bertagnolli, PhD, Professor contact
Rafael O Fernandes, PhD contact
Canada1 site
Hôpital du Sacre-Coer de Montréal - CIUSSS du Nord-de-l'Île-de-Montréal
Montreal, Quebec
Julie Hammamji, (514) 384-2000 ext. 3316, julie.hammamji.cnmtl@ssss.gouv.qc.ca
About this study
Official title: Postpartum Cardio-obstetric Rehabilitation After Hypertensive Pregnancy
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.
Read more
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.
Read the 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.
- Conditions
- Gestational Hypertension, Preeclampsia (PE)
- Being tested
- Postpartum Cardio-obstetric Rehabilitation Program
- Keywords
- postpartum rehabilitation, physical exercise, blood pressure, Pelvic Floor, gestational hypertension, pre-eclampsia, small vessels, endothelial function
- Medical subject headings
- Hypertension, Pregnancy-Induced, Pre-Eclampsia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Cardio-obstetric Rehabilitation ProgramOther
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Group | Experimental | 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. Receives: Other: Postpartum Cardio-obstetric Rehabilitation Program |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
24-hour Ambulatory Blood Pressure
24-hour Ambulatory Blood Pressure using OSCAR 2 equipment.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Secondary outcomes (22)
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 .
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
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.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
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.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Physical capacity (6MWT)
Six-minute walk test will be performed following the protocol described by the American Thoracic Society.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Physical activity levels
All participants will receive a wrist worn heart rate and accelerometer monitor (Fitbit Charge 6). This device will be used to monitor physical activity levels (total steps per week) and targeted heart rates during exercise training.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Body composition
Body composition will be measure using a bioimpedance scale InBody 570.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Timed Up and Go (TUG)
TUG test: The objective of TUG test is to assess mobility, balance and fall-risk. It consists of the participant stand-up from a chair, walk 3 meters, turn, walk back and sit down again. Interpretation: test performed ≤10 seconds indicates normal mobility.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Handgrip strength
The maximal handgrip strength will be performed using a manual Jamar Hydraulic Hand Dynamometer.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Glucose
Blood draw by venipuncture will be collected to measure glucose at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Angiogenic and proliferative function of peripheral blood ECFCs
Endothelial cell function will be assessed by the procedures described by Bertagnolli's team . ECFCs = Endothelial colony forming cell
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Plasmatic levels of angiogenic factors - VEGF
Serum concentration of angiogenic factors by ELISA following manufacturer instructions - Vascular endothelial growth factor (VEGF)
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Heart rate variability
R-R intervals will be recorded using a Vantage V2 Polar heart rate monitor at a sampling rate of 1,000 Hz. HRV will be recorded during deep breathing maneuver (continuous cycles) for 4 min in a supine position. HRV will be analyzed using Kubios HRV software following guidelines from the Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Circulating Endothelial Cells (cEC) Function
cEC tube formation capacity on matrigel, proliferation, and migration capacities.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Total cholesterol
Blood draw by venipuncture will be collected to measure total cholesterol at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Insuline
Blood draw by venipuncture will be collected to measure total cholesterol at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Glycated hemoglobin (HbA1c)
Blood draw by venipuncture will be collected to measure HbA1c at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
LDL cholesterol
Blood draw by venipuncture will be collected to measure LDL-cholesterol at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
HDL cholesterol
Blood draw by venipuncture will be collected to measure HDL cholesterol at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Triglycerides
Blood draw by venipuncture will be collected to measure triglycerides at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Brain Natriuretic Peptide (NT-PRO-BNP)
Blood draw by venipuncture will be collected to measure NT-PRO-BNP at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
C-reactive protein (CRP)
Blood draw by venipuncture will be collected to measure C-reactive protein (CRP) at the Biochemistry laboratory of the MUHC.
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Plasmatic levels of angiogenic factors - NO
Serum concentration of angiogenic factors by ELISA following manufacturer instructions - Nitric Oxide (NO).
Measured: Baseline, immediately post-intervention, and 6-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start15 Jun 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariane Bertagnolli, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920537
- Sponsor's protocol ID
- MP-32-2025-2963
- Status last verified
- May 2025
- First submitted
- 14 Mar 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Visser VS, Hermes W, Franx A, Koopmans CM, van Pampus MG, Mol BW, de Groot CJ. High blood pressure six weeks postpartum after hypertensive pregnancy disorders at term is associated with chronic hypertension. Pregnancy Hypertens. 2013 Oct;3(4):242-7. doi: 10.1016/j.preghy.2013.07.002. Epub 2013 Aug 9.
PubMed 26103803Phan K, Schiller I, Dendukuri N, Gomez YH, Gorgui J, El-Messidi A, Gagnon R, Daskalopoulou SS. A longitudinal analysis of arterial stiffness and wave reflection in preeclampsia: Identification of changepoints. Metabolism. 2021 Jul;120:154794. doi: 10.1016/j.metabol.2021.154794. Epub 2021 May 8.
PubMed 33971204Magee 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.
PubMed 26104418Lampinen KH, Ronnback M, Kaaja RJ, Groop PH. Impaired vascular dilatation in women with a history of pre-eclampsia. J Hypertens. 2006 Apr;24(4):751-6. doi: 10.1097/01.hjh.0000217859.27864.19.
PubMed 16531805Davenport 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.
PubMed 30343979Bellamy 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.
PubMed 17975258Bertagnolli 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.
PubMed 28170188
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Cardio-obstetric Rehabilitation After Hypertensive Pregnancy
- ClinicalTrials.gov ID
- NCT06920537
- Acronym / sponsor ID
- MP-32-2025-2963
- Conditions
- Gestational Hypertension, Preeclampsia (PE)
- Keywords
- postpartum rehabilitation, physical exercise, blood pressure, Pelvic Floor, gestational hypertension, pre-eclampsia, small vessels, endothelial function
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Group | Experimental | Other: Postpartum Cardio-obstetric Rehabilitation ProgramThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum Cardio-obstetric Rehabilitation ProgramThe 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. | Other | Rehabilitation Group |
Primary outcome
Office Blood Pressure
Time frame: 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
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
24-hour Ambulatory Blood Pressure using OSCAR 2 equipment.
22 secondary outcomes
Static Retinal Vascular Analysis
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Peripheral artery stiffness - PWV
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Peripheral artery stiffness - PWA
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Physical capacity (6MWT)
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Physical activity levels
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Body composition
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Timed Up and Go (TUG)
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Handgrip strength
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Glucose
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Angiogenic and proliferative function of peripheral blood ECFCs
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Plasmatic levels of angiogenic factors - VEGF
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Heart rate variability
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Circulating Endothelial Cells (cEC) Function
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Total cholesterol
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Insuline
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Glycated hemoglobin (HbA1c)
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
LDL cholesterol
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
HDL cholesterol
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Triglycerides
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Brain Natriuretic Peptide (NT-PRO-BNP)
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
C-reactive protein (CRP)
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Plasmatic levels of angiogenic factors - NO
Time frame: Baseline, immediately post-intervention, and 6-month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 26103803Visser VS, Hermes W, Franx A, Koopmans CM, van Pampus MG, Mol BW, de Groot CJ. High blood pressure six weeks postpartum after hypertensive pregnancy disorders at term is associated with chronic hypertension. Pregnancy Hypertens. 2013 Oct;3(4):242-7. doi: 10.1016/j.preghy.2013.07.002. Epub 2013 Aug 9.
- Background: PubMed 33971204Phan K, Schiller I, Dendukuri N, Gomez YH, Gorgui J, El-Messidi A, Gagnon R, Daskalopoulou SS. A longitudinal analysis of arterial stiffness and wave reflection in preeclampsia: Identification of changepoints. Metabolism. 2021 Jul;120:154794. doi: 10.1016/j.metabol.2021.154794. Epub 2021 May 8.
- Background: PubMed 26104418Magee 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.
- Background: PubMed 16531805Lampinen KH, Ronnback M, Kaaja RJ, Groop PH. Impaired vascular dilatation in women with a history of pre-eclampsia. J Hypertens. 2006 Apr;24(4):751-6. doi: 10.1097/01.hjh.0000217859.27864.19.
- Background: PubMed 30343979Davenport 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.
- Background: PubMed 17975258Bellamy 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.
- Background: PubMed 28170188Bertagnolli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariane Bertagnolli, PhD, Professor contact
Rafael O Fernandes, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Cardio-obstetric Rehabilitation Program in people with Gestational Hypertension and Preeclampsia (PE), run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariane Bertagnolli, PhD, Professor (514-388-2222 ext. 2501, mariane.bertagnolli.cnmtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Office Blood Pressure (time frame: Baseline, immediately post-intervention, and 6-month post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06920537, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.