Actively Recruiting

Age: 18Years - 80Years
All Genders
ID07169045

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

Led by Gazi University · Updated on 2026-02-03

24

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Peripheral artery disease (PAD) affects blood flow to the limbs and can cause problems like low muscle oxygen, balance issues, pain during walking, weak leg muscles, and stiff arteries. These problems reduce exercise ability and increase health risks. The study aims to check if the six-minute stepper test (6 MST), a simple and low-cost exercise test, is accurate and consistent for measuring exercise ability in people with PAD. It also looks at how factors like arterial stiffness, muscle oxygen, pain, balance, and muscle strength influence the 6 MST results. Participants with PAD will undergo several assessments including the 6 MST, cardiopulmonary exercise test (CPET), and six-minute walk test (6 MWT) to compare exercise capacity measures. The 6 MST will be repeated after 24 hours to test consistency. Additional tests will measure arterial stiffness, muscle oxygen levels, leg muscle strength, static and dynamic balance, and pain related to walking. Participants' health data and lung function will also be recorded. During the study, participants will complete these tests and questionnaires to evaluate how their condition affects exercise ability. Measurements will be taken at regular intervals throughout the study, which lasts about one year. Researchers will analyze the results to understand the relationship between physical factors and exercise capacity, helping improve how exercise tests are used for people with PAD.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with peripheral artery disease by the Department of Cardiovascular Surgery
  • Ankle-brachial index (ABI) 1.40 or less, or exercise ABI 0.73 or less, or diagnosed with calcified vascular response
  • Stable condition
  • Ages between 18 and 80 years
  • Volunteered to participate in the study
Not Eligible

You will not qualify if you...

  • Previous ischemic amputation
  • Unstable coronary artery disease
  • Uncontrolled diabetes mellitus
  • Pulmonary disease
  • Acute infection
  • Weight over 110 kg (due to device limits)
  • Contraindications to exercise testing
  • Pregnant or breastfeeding women
  • Major surgery or myocardial infarction within the last 3 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 year

Participants undergo assessments including pulmonary function tests, peripheral artery disease classification, comorbidity evaluation, and exercise capacity tests such as the cardiopulmonary exercise test, 6-minute walk test, and 6-minute stepper test to evaluate their functional exercise capacity and related health measures.

Multiple visits over the study period

Monitoring

Duration - Up to 1 year

Participants are observed over time to assess arterial stiffness, muscle oxygenation, muscle strength, balance, intermittent claudication, and symptom perception to examine their effects on exercise capacity and reliability of tests.

Assessments repeated at 24-hour intervals and periodically during the study

Trial Site Locations

Total: 1 location

1

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, Çankaya, Turkey (Türkiye), 06490

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Research Team

M

Meral BOŞNAK GÜÇLÜ

B

Beyza BEKDEMİR

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Balance impairment, physical ability, and its link with disease severity in patients with intermittent claudication.

Risha A Gohil, Katherine A Mockford, Fayyaz Mazari...

https://pubmed.ncbi.nlm.nih.gov/23084732

The Effects of Walking or Walking-with-Poles Training on Tissue Oxygenation in Patients with Peripheral Arterial Disease.

Eileen G Collins, Conor McBurney, Jolene Butler...

https://pubmed.ncbi.nlm.nih.gov/23050152

An original field evaluation test for chronic obstructive pulmonary disease population: the six-minute stepper test.

Benoit Borel, Claudine Fabre, Sylvain Saison...

https://pubmed.ncbi.nlm.nih.gov/20053721

2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS).

Victor Aboyans, Jean-Baptiste Ricco, Marie-Louise E L Bartelink...

https://pubmed.ncbi.nlm.nih.gov/28886620