NCT07169045 Validity and Reliability of the 6-minute Stepper Test in Patients With Peripheral Artery Disease
| NCT ID | NCT07169045 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Gazi University |
| Condition | Peripheral Artery Disease (PAD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-09-24 |
| Primary Completion | 2026-07-24 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 24 participants in total. It began in 2025-09-24 with a primary completion date of 2026-07-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Beyza BEKDEMİR
STUDY CHAIR
Gazi University
Frequently Asked Questions
Who can join the NCT07169045 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Peripheral Artery Disease (PAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07169045 currently recruiting?
Yes, NCT07169045 is actively recruiting participants. Contact the research team at merakbosnak@gazi.edu.tr for enrollment information.
Where is the NCT07169045 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT07169045 clinical trial?
NCT07169045 is sponsored by Gazi University. The principal investigator is Beyza BEKDEMİR at Gazi University. The trial plans to enroll 24 participants.