MenopauseWOMEN-EX-ICNCT07422961
Response to Aerobic Training in Postmenopausal Women With Exercise Intolerance.
A study testing Training in people with Menopause and Physical Activity, run by University of Poitiers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Physical Activity, Prevention
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 21 Sep 2022to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- Women with uncontrolled hypo- or hyperthyroidism (abnormal TSH).
- Women who have undergone left breast augmentation (implant).
- Women under legal guardianship or conservatorship.
Trial locations and contacts
1 site in 1 country.
France1 site
University of Poitiers - UFR STAPS - Laboratory MOVE
Poitiers, 86000
About this study
Official title: Response to Endurance 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.
Read the detailed description
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.
- Conditions
- Menopause, Physical Activity, Prevention, Cardiovascular (CV) Risk
- Being tested
- Training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
24 sessions of adapted physical activity at moderate intensity (aerobic exercise)
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | 24 sessions of adapted physical activity at moderate intensity (aerobic exercise) Receives: Other: Training |
| Control | No intervention | Maintaining lifestyle habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
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.
Measured: At Visit 1 and Visit 3 (30 minutes)
Secondary outcomes (10)
Exercise tolerance
Modified Borg scale during the cardiorespiratory exercise test (scored 0 to 10, higher score indicates lower exercise tolerance).
Measured: At Visit 1 and Visit 3 (30 minutes)
Muscle oxygenation
Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L) during the cardiorespiratory exercise test.
Measured: At Visit 1 and Visit 3 (30 minutes)
Body composition
Percentage of body fat and fat-free mass using the Tanita impedance scale.
Measured: At Visit 2 and Visit 4 (5 minutes)
Body mass index
Calculated from total body weight and height (kg/m²).
Measured: At Visit 2 and Visit 4 (5 minutes)
Aortic systolic and diastolic blood pressure
At rest, using the SphygmoCor device, which measures central blood pressure (mmHg).
Measured: At Visit 2 and Visit 4 (15 minutes)
Arterial stiffness (pulse wave velocity)
At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s).
Measured: At Visit 2 and Visit 4 (15 minutes)
Endothelial function (brachial artery dilation capacity)
At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps).
Measured: At Visit 2 and Visit 4 (30 minutes)
Systolic and diastolic blood pressure (ambulatory blood pressure measurement)
Systolic and diastolic blood pressure profile using the Mobil-O-Graph (mmHg).
Measured: After Visit 2 and Visit 4 (during 24 hours)
The Menopause-specific Quality of Life Questionnaire (MENQOL)
Composed of 29 items rating the impact of self-reported climateric symptoms in four domains (vasomotor, psychosocial, physical, and sexual).
Measured: At Visit 2 and Visit 4 (10 minutes)
SF-36 questionnaire
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)
Measured: At Visit 2 and Visit 4 (10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start21 Sep 2022
- Primary completion24 Jun 2025
- Study completion7 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Poitiers
- Sponsor type
- University, hospital or other
- Collaborators
- Elsan
- Responsible party
- Principal investigator, Laurent Bosquet, University of Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422961
- Sponsor's protocol ID
- 2021-A02337-34
- Acronym
- WOMEN-EX-IC
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response to Endurance Training in Postmenopausal Women With Exercise Intolerance.
- ClinicalTrials.gov ID
- NCT07422961
- Acronym / sponsor ID
- WOMEN-EX-IC / 2021-A02337-34
- Conditions
- Menopause, Physical Activity, Prevention, Cardiovascular (CV) Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of PoitiersUniversity, hospital or other
- Collaborators
- Elsan
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 20 Feb 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: Training24 sessions of adapted physical activity at moderate intensity (aerobic exercise) |
| Control | No intervention | –Maintaining lifestyle habits |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Training24 sessions of adapted physical activity at moderate intensity (aerobic exercise) | Other | Training |
Primary outcome
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.
10 secondary outcomes
Exercise tolerance
Time frame: At Visit 1 and Visit 3 (30 minutes)
Muscle oxygenation
Time frame: At Visit 1 and Visit 3 (30 minutes)
Body composition
Time frame: At Visit 2 and Visit 4 (5 minutes)
Body mass index
Time frame: At Visit 2 and Visit 4 (5 minutes)
Aortic systolic and diastolic blood pressure
Time frame: At Visit 2 and Visit 4 (15 minutes)
Arterial stiffness (pulse wave velocity)
Time frame: At Visit 2 and Visit 4 (15 minutes)
Endothelial function (brachial artery dilation capacity)
Time frame: At Visit 2 and Visit 4 (30 minutes)
Systolic and diastolic blood pressure (ambulatory blood pressure measurement)
Time frame: After Visit 2 and Visit 4 (during 24 hours)
The Menopause-specific Quality of Life Questionnaire (MENQOL)
Time frame: At Visit 2 and Visit 4 (10 minutes)
SF-36 questionnaire
Time frame: At Visit 2 and Visit 4 (10 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Menopause and Physical Activity, run by University of Poitiers at 1 site in France.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 27 Feb 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: At Visit 1 and Visit 3 (30 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.