Six-minute stepper test for people with peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will recruit adults aged 18–80 with diagnosed peripheral artery disease at Gazi University's Cardiopulmonary Rehabilitation Unit. Participants will perform the six-minute stepper test (6MST), likely with repeat testing for reliability, alongside reference measures of exercise capacity and related variables such as muscle oxygenation, balance, intermittent claudication pain, lower extremity strength, and arterial stiffness. The study will compare 6MST results with established measures (such as cardiopulmonary exercise testing or other functional tests) to examine agreement and correlations. Data analysis will focus on validity (how well the 6MST reflects true exercise capacity) and test-retest reliability in this patient group.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
  Ankara, Çankaya, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Nihan KATAYIFÇI — Gazi University
• Study coordinator: Meral BOŞNAK GÜÇLÜ
• Email: merakbosnak@gazi.edu.tr
• Phone: +90(312)2162647

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.