Hemodynamic dysfunction and decreased blood flow to the extremities negatively affect patients' muscle oxygenation, balance, claudication pain, lower extremity muscle strength, and arterial stiffness. These negatively affect patients' exercise capacity. The six-minute stepper test (6 MST) is a simple, low-cost, and minimal space requirement assessment method used to evaluate functional exercise capacity and is known to be valid and reliable for various pulmonary and cardiovascular diseases. However, it is not known whether the 6 MST is valid and reliable in assessing functional exercise capacity in patients with PAD. It is known that muscle oxygen levels, balance levels, intermittent claudication, lower extremity muscle strength, and arterial stiffness have negative effects on exercise capacity. However, the extent to which these variables affect the 6 MST is unknown. The primary aim is to examine the validity and reliability of the 6 MST in patients with PAD. The secondary aim is to evaluate arterial stiffness, muscle oxygen levels, intermittent claudication, static and dynamic balance levels, lower extremity muscle strength, and examine their effects on the 6 MST.
Diagnosed with peripheral artery disease by the Department of Cardiovascular Surgery,
Ankle-brachial index (ABI) ≤1.40 or exercise ABI ≤0.73 or diagnosed with calcified vascular response, in remission and under follow-up,
Stable,
Ages between 18 and 80,
Previously underwent ischaemic amputation,
Unstable coronary artery disease,
Uncontrolled Diabetes Mellitus,
Pulmonary disease,
24 patients diagnosed with peripheral artery disease will be recruited
Case-only
Cross-sectional
Not listed
6-minute Stepper Test
The test will performed using the previously defined Borel et al. criteria and the adaptation of the ATS/ERS 6 MWT criteria. For the test, a standard resistance 'Stepper' device will used, positioned 20 cm above the ground. To enable the patient to receive support if they lose their balance, the stepper device will placed 10 cm away from a straight wall edge. Patients will asked to take as many steps as possible during 6 minutes. The test will be conducted for 2 minutes first for the patient to learn, and then 6 minutes of testing will be conducted after a 3-minute rest period. 6 MST will be re-applied to patients 24 hours later using the same protocol for reliability analysis.
Cardiopulmonary Exercise Test
CPET is the gold standard method used to assess maximal exercise capacity. For this reason, 6 MST will used to examine structural validity. CPET will be performed using a gradually increasing workload protocol with breath-by-breath measurement on a treadmill. Electrocardiography (ECG) assessment during the test will be performed using a 12-lead ECG trace. Oxygen consumption and metabolic equivalent will be measured.
6-minute Walk Test
The 6 MWT is a valid and reliable submaximal exercise test for patients with peripheral arterial disease. 6 MWT will be applied to examine the structural validity of 6 MST. It will be carried out in accordance with ATS criteria.The walking distance will be recorded in two ways: in metres and as a percentage of the expected walking distance.
Pulmonary function test
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), FEV1/FVC, peak expiratory flow rate (PEF), and flow rate 25-75% of forced expiratory volume (FEV25-75%) will be measured.
Classification Systems for Peripheral Artery Disease
It will be performed using the Fontaine and Rutherford classification systems. According to the Fontaine classification system, peripheral arterial disease in individuals is assessed as stage I: asymptomatic disease, stage Ia: mild claudication, stage Ib: moderate-severe claudication, stage II: pain at rest, stage IV: ulceration or gangrene. According to the Rutherford classification system, it is classified as follows: 0: Asymptomatic, 1: Mild claudication, 2: Moderate claudication, 3: Severe claudication, 4: Ischemic rest pain, 5: Minor tissue loss, 6: Major tissue loss.
Charlson Comorbidity Index
This index identifies and defines 19 comorbid chronic diseases accompanying patients' primary diseases and determines the mortality risk. The total score obtained from the index ranges from 0 to 37.
Arterial Stiffness
Arterial stiffness will be assessed using the SphygmoCor® XCEL device. The patient's peripheral blood pressure will be measured by partially inflating the cuff on the brachial artery. Then, to assess carotid PWV, carotid pulse waves will be measured with a tonometer. A cuff will be placed on the femoral area to measure femoral PWV. The device will measure carotid-femoral artery PWV, pulse transit time, augmented index (Aix) values.
Click on the lead sponsor to view all of their trials.
