Assessment of Exercise Capacity, Muscle Oxygenation and Aortic Stiffness in Patients With Mitral Stenosis
ConditionMitral Stenosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorGazi University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Between the ages of 18 and 80
Disqualifiers
Patients who have undergone aortic valve intervention other than mitral valve intervention
Acute infection
Orthopedic, neurological or psychological disorders that will affect functional capacity
diagnosed chronic disease,
Trial population
30 patients with a history of mitral valve intervention for mitral stenosis and 30 healthy individuals will be recruited.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
40 Participants
are grouped into 2 trial groupsGroup A: Patients group
Group B: Healthy Controls Group
Trial outcomes
Primary outcomes
1
Maximal Exercise Capacity
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.
Time frame
Through study completion, an average of 1 year2
Muscle Oxygenation
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.
Time frame
Through study completion, an average of 1 year3
Aortic Stiffness
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).
Time frame
Through study completion, an average of 1 year4
Quality of Life (Short Form 36)
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.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
Respiratory Muscle Strength
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.
Time frame
Through study completion, an average of 1 year2
Respiratory Muscle Endurance
Respiratory muscle endurance will be assessed using the incremental threshold loading test.
Time frame
Through study completion, an average of 1 year3
Pulmonary Function (Forced vital capacity (FVC))
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.
Time frame
Through study completion, an average of 1 year4
Pulmonary Function (Forced expiratory volume in first second (FEV1))
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.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov