Response to Aerobic Training in Postmenopausal Women With Exercise Intolerance.

What this trial studies

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.

Conditions in scope

• Menopause
• Physical Activity
• Prevention
• Cardiovascular (CV) Risk

Interventions

• Training (Other) — 24 sessions of adapted physical activity at moderate intensity (aerobic exercise)

Who can join

Women only · Ages 40 Years to 70 Years · Accepts healthy volunteers.

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/dL).
• Women with uncontrolled hypo- or hyperthyroidism (abnormal TSH).
• Women who have undergone left breast augmentation (implant).

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Completed
• Study type: Interventional
• Phase: N/A
• Start date: 2022-09-21
• Primary completion: 2025-06-24
• Last update posted: 2026-02-27
• First posted: 2026-02-20

Sponsor & contact

Lead sponsor: University of Poitiers (Other)

Collaborators: Elsan

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Cardiorespiratory fitness (At Visit 1 and Visit 3 (30 minutes))
  Maximal cardiopulmonary exercise test (VO2 peak) on a cycloergometer using an incremental protocol, supervised by a cardiologist. The test started at 30 watts, increasing by 15 watts per minute until maximum capacity was reached.

Related ClearedRx care

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