Response to Aerobic Training in Postmenopausal Women With Exercise Intolerance.

NCT07422961 | Completed

• 1 other identifier: 2021-A02337-34
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  At Visit 1 and Visit 3 (30 minutes)

Secondary Outcomes (10)

• Exercise tolerance

  At Visit 1 and Visit 3 (30 minutes)

• Muscle oxygenation

  At Visit 1 and Visit 3 (30 minutes)

• Body composition

  At Visit 2 and Visit 4 (5 minutes)

• Body mass index

  At Visit 2 and Visit 4 (5 minutes)

• Aortic systolic and diastolic blood pressure

  At Visit 2 and Visit 4 (15 minutes)

Other Outcomes (12)

• Age

  Baseline

• Number of children

  Baseline

• Tobacco use

  Baseline

Study Arms (2)

Training

EXPERIMENTAL

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

Other: Training

Control

NO INTERVENTION

Maintaining lifestyle habits

Interventions

Training OTHER

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

Training

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Poitiers: lead
• Elsan: collaborator

Study Sites (1)

University of Poitiers - UFR STAPS - Laboratory MOVE

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 20, 2026
• Study Start: September 21, 2022
• Primary Completion: June 24, 2025
• Study Completion: July 7, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

FR (1)