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Completed

NCT Number: NCT07422961

Response to Aerobic Training in Postmenopausal Women With Exercise Intolerance.

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.

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Key information

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Poitiers - UFR STAPS - Laboratory MOVE

Poitiers, 86000, France

About this study

Cardiovascular diseases (CVDs) remain the leading cause of morbidity and mortality worldwide and represent a major public health challenge. Importantly, growing evidence highlights significant sex-related differences in the epidemiology, clinical presentation, and pathophysiology of cardiovascular diseases. In particular, postmenopause represents a period of life associated with an increased risk of CVD.

Several physiological mechanisms may underlie these sex-related disparities. Differences in cardiac structure and function, vascular properties, and metabolic regulation contribute to distinct cardiovascular health between men and women. Moreover, the transition to menopause and the associated decline in circulating sex hormones are thought to play a key role in cardiovascular remodeling and functional alterations.

For many years, physical activity has been considered a first-line non-pharmacological strategy in the prevention and treatment of cardiovascular diseases. More specifically, aerobic training has been shown to improves exercise tolerance and quality of life in patients. Indeed, sentinel studies highlight an improvement in aerobic power (VO2 peak) linked to peripheral adaptations (increase in the arteriovenous difference in O2 in the muscles used) and not to central adaptations (no changes in systolic and diastolic functions). However, these studies did not assess the effects of hormonal status , whereas numerous studies on healthy subjects have highlighted the influence of sex hormones on cardiovascular responses to acute and chronic exercise.

The aims of this study:

  • Evaluate the effects of 24 aerobic training sessions (over 8-12 weeks) on exercise tolerance in postmenopausal women (peak VO2 and exercise dyspnea using the Borg scale).
  • Second, evaluate the effects of 24 aerobic training sessions key indices of cardiovascular physiology (e.g., arterial stiffness, endothelial dysfunction, and muscle oxygenation).
  • Thirds, to evaluate the effects of the training sessions on the quality-of-life score of postmenopausal women.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).
  • Women under legal guardianship or conservatorship.

Treatment and study plan

Training

Other

24 sessions of adapted physical activity at moderate intensity (aerobic exercise)

Primary outcomes

  1. Cardiorespiratory fitness

    Time frame: 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.

Secondary outcomes

  1. Exercise tolerance

    Time frame: At Visit 1 and Visit 3 (30 minutes)

    Modified Borg scale during the cardiorespiratory exercise test (scored 0 to 10, higher score indicates lower exercise tolerance).

  2. Muscle oxygenation

    Time frame: At Visit 1 and Visit 3 (30 minutes)

    Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L) during the cardiorespiratory exercise test.

  3. Body composition

    Time frame: At Visit 2 and Visit 4 (5 minutes)

    Percentage of body fat and fat-free mass using the Tanita impedance scale.

  4. Body mass index

    Time frame: At Visit 2 and Visit 4 (5 minutes)

    Calculated from total body weight and height (kg/m²).

  5. Aortic systolic and diastolic blood pressure

    Time frame: At Visit 2 and Visit 4 (15 minutes)

    At rest, using the SphygmoCor device, which measures central blood pressure (mmHg).

  6. Arterial stiffness (pulse wave velocity)

    Time frame: At Visit 2 and Visit 4 (15 minutes)

    At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s).

  7. Endothelial function (brachial artery dilation capacity)

    Time frame: At Visit 2 and Visit 4 (30 minutes)

    At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps).

  8. Systolic and diastolic blood pressure (ambulatory blood pressure measurement)

    Time frame: After Visit 2 and Visit 4 (during 24 hours)

    Systolic and diastolic blood pressure profile using the Mobil-O-Graph (mmHg).

  9. The Menopause-specific Quality of Life Questionnaire (MENQOL)

    Time frame: At Visit 2 and Visit 4 (10 minutes)

    Composed of 29 items rating the impact of self-reported climateric symptoms in four domains (vasomotor, psychosocial, physical, and sexual).

  10. SF-36 questionnaire

    Time frame: At Visit 2 and Visit 4 (10 minutes)

    36-item self-report questionnaire measuring health-related quality of life across eight domains (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health)

Other outcomes

  1. Age

    Time frame: Baseline

    Age, and menopause age (in years)

  2. Number of children

    Time frame: Baseline

    Self-reported

  3. Tobacco use

    Time frame: Baseline

    Current, former, never

  4. Comorbidities

    Time frame: Baseline

  5. Medical treatment

    Time frame: Baseline

  6. Physical activity level

    Time frame: Baseline (5 minutes)

    Ricci & Gagnon Questionnaire - Inclusion criteria

  7. Blood hormone concentrations

    Time frame: Baseline

    17-beta-estradiol, and follicle-stimulating hormone (ng/L) - Inclusion criteria

  8. NTproBNP

    Time frame: Baseline

    Biomarker of cardiac insufficiency (pg/mL) - Inclusion criteria

  9. TSH

    Time frame: Baseline

    Biomarker of uncontrolled thyroid (MUI/L) - Inclusion criteria

  10. Complete Blood Count

    Time frame: Baseline

    Hemoglobin (g/dL), hematocrit (%) - Inclusion criteria

  11. Spirometry

    Time frame: At Visit 1 (baseline, 15 minutes)

    FEV₁/FVC ratio - Inclusion criteria

  12. Stress echocardiography

    Time frame: At Visit 1 (baseline, 30 minutes)

    A progressive incremental exercise test performed on a supine ergometer, combined with echocardiographic measurements taken before, during, and after exercise in order to detect ischemia, contractile abnormalities, valvular dysfunction. - Inclusion criteria

Sponsors and collaborators

Lead sponsor

University of Poitiers

Other

Collaborators

  • Elsan

Registry information

Official study title

Response to Endurance Training in Postmenopausal Women With Exercise Intolerance.

Acronym: WOMEN-EX-IC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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