Postpartum CO Rehabilitation

NCT06920537 | Not Yet Recruiting

• 1 other identifier: MP-32-2025-2963
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Hypertension; Preeclampsia (PE)

Keywords

postpartum rehabilitation; physical exercise; blood pressure; Pelvic Floor; gestational hypertension; pre-eclampsia; small vessels; endothelial function

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline, immediately post-intervention, and 6-month post-intervention

• 24-hour Ambulatory Blood Pressure

  24-hour Ambulatory Blood Pressure using OSCAR 2 equipment.

  Baseline, immediately post-intervention, and 6-month post-intervention

Secondary Outcomes (22)

• 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

Other Outcomes (10)

• SF-36 Quality of Life Questionnaire (SF-36).

  Baseline, immediately post-intervention, and 6-month post-intervention

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, immediately post-intervention, and 6-month post-intervention

• Edinburgh Postnatal Depression Scale (EPDS).

  Baseline, immediately post-intervention, and 6-month post-intervention

Study Arms (2)

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.

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.

Interventions

Postpartum Cardio-obstetric Rehabilitation Program OTHER

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.

Rehabilitation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hôpital du Sacre-Coer de Montréal - CIUSSS du Nord-de-l'Île-de-Montréal

Montreal, Quebec, Canada

Location

Related Publications (7)

• 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.

  PMID: 26103803 BACKGROUND

• Phan 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.

  PMID: 33971204 BACKGROUND

• 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.

  PMID: 26104418 BACKGROUND

• Lampinen 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.

  PMID: 16531805 BACKGROUND

• 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.

  PMID: 30343979 BACKGROUND

• 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.

  PMID: 17975258 BACKGROUND

• 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.

  PMID: 28170188 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Pre-Eclampsia; Motor Activity

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

Mariane Bertagnolli, PhD, Professor

CONTACT

514-388-2222; mariane.bertagnolli.cnmtl@ssss.gouv.qc.ca

Rafael O Fernandes, PhD

CONTACT

rafael.fernandes@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research team that will evaluate the participants will be blind to the group - intervention or control (conventional care).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Scientist

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 9, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)