Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:52 AM
Study NCT ID:
NCT07422961
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response to Aerobic Training in Postmenopausal Women With Exercise Intolerance.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-23', 'studyFirstSubmitDate': '2026-02-12', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'Baseline', 'description': 'Age, and menopause age (in years)'}, {'measure': 'Number of children', 'timeFrame': 'Baseline', 'description': 'Self-reported'}, {'measure': 'Tobacco use', 'timeFrame': 'Baseline', 'description': 'Current, former, never'}, {'measure': 'Comorbidities', 'timeFrame': 'Baseline'}, {'measure': 'Medical treatment', 'timeFrame': 'Baseline'}, {'measure': 'Physical activity level', 'timeFrame': 'Baseline (5 minutes)', 'description': 'Ricci \\& Gagnon Questionnaire - Inclusion criteria'}, {'measure': 'Blood hormone concentrations', 'timeFrame': 'Baseline', 'description': '17-beta-estradiol, and follicle-stimulating hormone (ng/L) - Inclusion criteria'}, {'measure': 'NTproBNP', 'timeFrame': 'Baseline', 'description': 'Biomarker of cardiac insufficiency (pg/mL) - Inclusion criteria'}, {'measure': 'TSH', 'timeFrame': 'Baseline', 'description': 'Biomarker of uncontrolled thyroid (MUI/L) - Inclusion criteria'}, {'measure': 'Complete Blood Count', 'timeFrame': 'Baseline', 'description': 'Hemoglobin (g/dL), hematocrit (%) - Inclusion criteria'}, {'measure': 'Spirometry', 'timeFrame': 'At Visit 1 (baseline, 15 minutes)', 'description': 'FEV₁/FVC ratio - Inclusion criteria'}, {'measure': 'Stress echocardiography', 'timeFrame': 'At Visit 1 (baseline, 30 minutes)', 'description': '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'}], 'primaryOutcomes': [{'measure': 'Cardiorespiratory fitness', 'timeFrame': 'At Visit 1 and Visit 3 (30 minutes)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Exercise tolerance', 'timeFrame': 'At Visit 1 and Visit 3 (30 minutes)', 'description': 'Modified Borg scale during the cardiorespiratory exercise test (scored 0 to 10, higher score indicates lower exercise tolerance).'}, {'measure': 'Muscle oxygenation', 'timeFrame': 'At Visit 1 and Visit 3 (30 minutes)', 'description': 'Near-infrared spectroscopy is used to measure concentrations of oxygenated and desoxygenated hemoglobin (µmol/L) during the cardiorespiratory exercise test.'}, {'measure': 'Body composition', 'timeFrame': 'At Visit 2 and Visit 4 (5 minutes)', 'description': 'Percentage of body fat and fat-free mass using the Tanita impedance scale.'}, {'measure': 'Body mass index', 'timeFrame': 'At Visit 2 and Visit 4 (5 minutes)', 'description': 'Calculated from total body weight and height (kg/m²).'}, {'measure': 'Aortic systolic and diastolic blood pressure', 'timeFrame': 'At Visit 2 and Visit 4 (15 minutes)', 'description': 'At rest, using the SphygmoCor device, which measures central blood pressure (mmHg).'}, {'measure': 'Arterial stiffness (pulse wave velocity)', 'timeFrame': 'At Visit 2 and Visit 4 (15 minutes)', 'description': 'At rest, using the SphygmoCor device, which calculates carotid-femoral pulse wave velocity (m/s).'}, {'measure': 'Endothelial function (brachial artery dilation capacity)', 'timeFrame': 'At Visit 2 and Visit 4 (30 minutes)', 'description': 'At rest, the flow-mediated dilatation technique is used with high-resolution Doppler ultrasound (CX-50 Philipps).'}, {'measure': 'Systolic and diastolic blood pressure (ambulatory blood pressure measurement)', 'timeFrame': 'After Visit 2 and Visit 4 (during 24 hours)', 'description': 'Systolic and diastolic blood pressure profile using the Mobil-O-Graph (mmHg).'}, {'measure': 'The Menopause-specific Quality of Life Questionnaire (MENQOL)', 'timeFrame': 'At Visit 2 and Visit 4 (10 minutes)', 'description': 'Composed of 29 items rating the impact of self-reported climateric symptoms in four domains (vasomotor, psychosocial, physical, and sexual).'}, {'measure': 'SF-36 questionnaire', 'timeFrame': 'At Visit 2 and Visit 4 (10 minutes)', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Menopause', 'Physical Activity', 'Prevention', 'Cardiovascular (CV) Risk']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nSeveral 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.\n\nFor 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.\n\nThe aims of this study:\n\n* 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).\n* Second, evaluate the effects of 24 aerobic training sessions key indices of cardiovascular physiology (e.g., arterial stiffness, endothelial dysfunction, and muscle oxygenation).\n* Thirds, to evaluate the effects of the training sessions on the quality-of-life score of postmenopausal women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* COVID-19 vaccination.\n* Echocardiographic ejection fraction \\> 50% and NT-proBNP \\< 220 pg/mL.\n* Women in sinus rhythm or with paroxysmal or permanent atrial fibrillation.\n* 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.\n\nExclusion Criteria:\n\n* 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).\n* Women with significant obesity (BMI \\> 30 kg/m²).\n* Unstable women (systolic blood pressure \\< 100 mmHg, resting heart rate \\> 100 bpm) or women with clinical congestion (cardiac-related lower limb edema, pulmonary crackles).\n* Women with pulmonary function tests indicating significant respiratory disease (FEV₁/FVC \\< 0.7, TLC \\< LLN).\n* Women with chronic renal failure with creatinine clearance \\< 30 mL/min (MDRD) or on dialysis.\n* Women with anemia (Hb \\< 12 g/dL).\n* Women with uncontrolled hypo- or hyperthyroidism (abnormal TSH).\n* Women who have undergone left breast augmentation (implant).\n* Women under legal guardianship or conservatorship.'}, 'identificationModule': {'nctId': 'NCT07422961', 'acronym': 'WOMEN-EX-IC', 'briefTitle': 'Response to Aerobic Training in Postmenopausal Women With Exercise Intolerance.', 'organization': {'class': 'OTHER', 'fullName': 'University of Poitiers'}, 'officialTitle': 'Response to Endurance Training in Postmenopausal Women With Exercise Intolerance.', 'orgStudyIdInfo': {'id': '2021-A02337-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Training', 'description': '24 sessions of adapted physical activity at moderate intensity (aerobic exercise)', 'interventionNames': ['Other: Training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Maintaining lifestyle habits'}], 'interventions': [{'name': 'Training', 'type': 'OTHER', 'description': '24 sessions of adapted physical activity at moderate intensity (aerobic exercise)', 'armGroupLabels': ['Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'University of Poitiers - UFR STAPS - Laboratory MOVE', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Poitiers', 'class': 'OTHER'}, 'collaborators': [{'name': 'Elsan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Laurent Bosquet', 'investigatorAffiliation': 'University of Poitiers'}}}}