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NCT Number: NCT07394998

Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral Stenosis

Heart valve diseases are the most common cause of mortality and morbidity after coronary artery disease, hypertension, and heart failure. In patients with mitral stenosis, the narrowed valve restricts blood flow, causing symptoms such as shortness of breath, fatigue, exertional dyspnea, orthopnea, and paroxysmal nocturnal dyspnea. These patients may experience decreased exercise capacity and physical activity levels, deterioration in quality of life, and deterioration in respiratory function. When reviewing the literature, we see that the study groups evaluating these factors are generally not homogeneous, and most studies conducted in patients with mitral stenosis evaluate patients who have undergone percutaneous mitral balloon valvuloplasty.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, 06490, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ebrar TÜLÜMENOĞLU, Pt

CONTACT

[email protected]

+905434157799

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

[email protected]

+90(312)2162647

About this study

In mitral valve stenosis, blood flow from the left atrium to the left ventricle is mechanically restricted, resulting in increased pressure in the left atrium, pulmonary vascular bed, and right chambers of the heart. The narrowed mitral valve obstructs the flow of blood from the lungs to the heart, causing shortness of breath in patients. Increased blood volume in the left atrium may cause palpitations. Other symptoms include fatigue, exertional dyspnea, orthopnea, paroxysmal nocturnal dyspnea, chest pain, and dizziness.

Patients with mitral stenosis are expected to have decreased exercise capacity due to restrictive lung function, chronotropic insufficiency, limited stroke volume, and the effects of peripheral factors. Studies evaluating the exercise capacity of patients who have undergone surgery for mitral stenosis are limited.

After cardiac surgery, oxygen saturation decreases in the acute period, and hemodynamic and systemic oxygenation are often impaired. It has been suggested that muscle deoxygenation may also occur in patients with mitral stenosis due to these reasons. Studies investigating skeletal muscle oxygenation after mitral valve surgery are limited in the literature. While surgery for heart valve lesions improves cardiac function, changes in the thoracic compartment are major causes of mortality and morbidity. These changes reduce cardiorespiratory capacity, leading to physical inactivity, loss of muscle strength, and loss of fitness in patients.

Inspiratory muscle performance is impaired in patients who have undergone valve replacement surgery. Better inspiratory muscle performance in these patients is associated with better physical function. This relationship between respiratory muscle strength and exercise capacity demonstrates the importance of assessing respiratory muscle strength. Mitral valve stenosis is associated with impaired aortic stiffness. In patients with heart failure, aortic stiffening plays a role in hemodynamic deterioration due to its adverse effect on left ventricular function and coronary artery perfusion. In conclusion, aortic stiffness has been shown to exacerbate the disease through multiple mechanisms. Inadequate physical activity after heart valve surgery is associated with a higher mortality rate, while adequate physical activity prevents cardiovascular events and reduces mortality in the long term. Physical activity is an important prognostic factor in patients who have undergone cardiac surgery. The quality of life of patients improves after heart valve surgery. The extent of improvement may vary depending on the surgical method used.

The primary objective of the study is to compare exercise capacity, muscle oxygenation, aortic stiffness, and quality of life in patients who have undergone surgery for mitral stenosis with those in healthy individuals.

The secondary objective of the study is to compare respiratory muscle strength and endurance, pulmonary function, and physical activity levels in patients who have undergone surgery for mitral stenosis with those in healthy individuals.

Primary outcomes are exercise capacity, muscle oxygenation, aortic stiffness, and quality of life.

Secondary outcomes are respiratory muscle strength, respiratory muscle endurance, pulmonary function and physical activity level.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patients;

  • Between the ages of 18-80
  • Patients who have undergone mitral valve intervention due to mitral stenosis
  • At least 3 months have passed since the intervention

Healthy controls;

  • Between the ages of 18 and 80
  • Agreeing to participate voluntarily in the study

Exclusion criteria

Patients;

  • Patients who have undergone aortic valve intervention other than mitral valve intervention
  • Acute infection
  • Orthopedic, neurological or psychological disorders that will affect functional capacity

Healthy Controls;

  • diagnosed chronic disease,
  • acute infection
  • A smoking history of at least 10 packs×years or more

Treatment and study plan

Primary outcomes

  1. Maximal Exercise Capacity

    Time frame: Through study completion, an average of 1 year

    Maximal Exercise capacity will be evaluated with Cardiopulmonary Exercise testing. The Cardiopulmonary Exercise Testing will be applied according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  2. Muscle Oxygenation

    Time frame: Through study completion, an average of 1 year

    Peripheral muscle oxygen will be measured by near-infrared spectrometry. The device probes will be placed on the trunk and lower extremities. The device allows to display of the percentage of oxygen, the concentration of oxyhemoglobin, and deoxyhemoglobin, the difference between oxyhemoglobin and deoxyhemoglobin, and the total hemoglobin. These parameters will be evaluated in our study.

  3. Aortic Stiffness

    Time frame: Through study completion, an average of 1 year

    Aortic stiffness will be assessed non-invasively using the SphygmoCor XCEL® device, whose validity and reliability have been proven. The device measures carotid-femoral pulse wave velocity (cfPWV).

  4. Quality of Life (Short Form 36)

    Time frame: through study completion, an average of 1 year

    Health-related quality of life will be assessed using the valid and reliable Short Form 36 (SF-36). The SF-36 consists of a total of 36 items across 8 health domains. The 8 health domains assessed are general health, physical functioning, social functioning, physical limitations due to health problems, emotional limitations due to health problems, pain, mental health, and energy/vitality. It assesses the individual's last month using a Likert scale. Each health domain is scored between 0 and 100. A higher score indicates better health status.

Secondary outcomes

  1. Respiratory Muscle Strength

    Time frame: Through study completion, an average of 1 year

    Maximal inspiratory (MIP) and maximal expiratory (MEP) pressures expressing respiratory muscle strength were measured using a portable mouth pressure measuring device according to American Thoracic Society and European Respiratory Society criteria.

  2. Respiratory Muscle Endurance

    Time frame: Through study completion, an average of 1 year

    Respiratory muscle endurance will be assessed using the incremental threshold loading test.

  3. Pulmonary Function (Forced vital capacity (FVC))

    Time frame: Through study completion, an average of 1 year

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced vital capacity (FVC)was evaluated.

  4. Pulmonary Function (Forced expiratory volume in first second (FEV1))

    Time frame: Through study completion, an average of 1 year

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, forced expiratory volume in first second (FEV1) was evaluated.

  5. Pulmonary Function (FEV1/FVC)

    Time frame: Through study completion, an average of 1 year

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, FEV1/FVC was evaluated.

  6. Pulmonary Function (Flow rate 25-75% of forced expiratory volume (FEF25-75%))

    Time frame: Through study completion, an average of 1 year

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, Flow rate 25-75% of forced expiratory volume (FEF25-75%)was evaluated.

  7. Pulmonary Function (Peak flow rate (PEF))

    Time frame: Through study completion, an average of 1 year

    Pulmonary function was evaluated using the spirometry. Dynamic lung volume measurements were conducted according to ATS and ERS criteria. With the device, peak flow rate (PEF) was evaluated.

  8. Physical Activity Level

    Time frame: Through study completion, an average of 1 year

    Physical activity level will be assessed using a multi-sensor activity monitor. The patient will wear the multi-sensor activity monitor continuously for 4 days using a belt at hip level on the non-dominant side.

Study contacts

Contact information is provided by the study sponsor or research team.

Ebrar TÜLÜMENOĞLU, Pt

CONTACT

[email protected]

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

[email protected]

+90(312)2162647

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

Comparison of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With a History of Mitral Valve Intervention for Mitral Stenosis With Healthy Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 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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