CompletedNot Applicable

Response to Aerobic Training in Postmenopausal Women With Exercise Intolerance.

France43 participantsStarted 2022-09-21

Plain-language summary

Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide and represent a major public health challenge, with growing evidence highlighting important sex-related differences in their epidemiology, clinical presentation, and pathophysiology. In particular, menopause is associated with an increased cardiovascular risk, likely due to the decline in sex hormones and related changes in cardiac structure and function, vascular properties, and metabolic regulation. Several studies show that physical activity and, more specifically, aerobic training improves exercise tolerance and quality of life in patients. However, no studies have evaluated the effects of hormonal status, despite numerous studies on healthy subjects highlighting the influence of sex hormones on cardiovascular responses to acute and chronic exercise.

Who can participate

Age range

40 Years – 70 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Postmenopausal women under 70 years of age (absence of menstruation for 12 consecutive months and estradiol \< 20 pg/mL and/or FSH \> 40 mIU/mL), presenting with unexplained exertional dyspnea. * COVID-19 vaccination. * Echocardiographic ejection fraction \> 50% and NT-proBNP \< 220 pg/mL. * Women in sinus rhythm or with paroxysmal or permanent atrial fibrillation. * Women considered physically inactive according to WHO recommendations (150 minutes of moderate-intensity endurance activity per week, or at least 75 minutes of vigorous-intensity endurance activity, or an equivalent combination of moderate- and vigorous-intensity activity. Exclusion Criteria: * Women with significant coronary heart disease, severe valvular disease (grade III or IV/IV), significant hypertrophic or hypertensive heart disease (LVH with wall thickness ≥ 13 mm), infiltrative disease (amyloidosis, Fabry disease, etc.), constrictive disease, or significant and/or progressive arrhythmic disease (ventricular arrhythmia). * Women with significant obesity (BMI \> 30 kg/m²). * Unstable women (systolic blood pressure \< 100 mmHg, resting heart rate \> 100 bpm) or women with clinical congestion (cardiac-related lower limb edema, pulmonary crackles). * Women with pulmonary function tests indicating significant respiratory disease (FEV₁/FVC \< 0.7, TLC \< LLN). * Women with chronic renal failure with creatinine clearance \< 30 mL/min (MDRD) or on dialysis. * Women with anemia (Hb \< 12 g…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiorespiratory fitness

Timeframe: At Visit 1 and Visit 3 (30 minutes)

Trial details

NCT IDNCT07422961

SponsorUniversity of Poitiers

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-24

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