Six-minute stepper test for people with peripheral artery disease
Examination of the Validity and Reliability of 6-minute Stepper Test in Patients With Peripheral Artery Disease
This project will test whether the six-minute stepper test can measure exercise ability in adults with peripheral artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Gazi University Academic / other |
| Locations | 1 site (Ankara, Çankaya) |
| Trial ID | NCT07169045 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are stable adults (18–80 years) with diagnosed peripheral artery disease (ABI criteria or calcified vessels), weighing ≤110 kg, who can safely perform stepper exercise and who volunteer to participate.
Not a fit: Patients with recent major cardiac events or surgery, unstable coronary disease, uncontrolled diabetes, pulmonary disease, active infection, prior ischemic amputation, pregnancy/breastfeeding, or those unable to step safely (including weight >110 kg) are unlikely to benefit from this test or be eligible for participation.
Why it matters
Potential benefit: If successful, the 6MST could offer a simple, low-cost way to measure exercise capacity and help guide exercise programs for patients with PAD.
How similar studies have performed: The 6MST has shown validity and reliability in various pulmonary and cardiovascular populations, but its use specifically in PAD patients is largely untested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ankara, Çankaya
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.