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Validity and Reliability of the 6-minute Stepper Test in Patients With Peripheral Artery Disease

Recruitingn/aAges 18 Years - 80 YearsAllGazi University
NCT07169045 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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, * Patients who volunteer to participate in the study will be included. Exclusion Criteria: * Patients will be excluded if they have: * Previously underwent ischaemic amputation, * Unstable coronary artery disease, * Uncontrolled Diabetes Mellitus, * Pulmonary disease, * Acute infection, * Weight \>110 kg because it is the upper limit of the stepper device, * Contraindications to exercise testing per the American Sports Medicine Association, * Pregnant and breastfeeding women, * Patients with PAD who have undergone major surgery or had a myocardial infarction within the last 3 months.
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What it tests

  • Not listed
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Where

1 site
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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