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

Official title

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

Overview

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.

Detailed description

Peripheral artery disease (PAD) is a common condition that carries a high risk of cardiovascular morbidity and mortality. PAD is an atherosclerotic process that causes occlusion of peripheral arteries. 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 and increase the risk of mortality. To prevent this, patients' exercise capacity should be properly assessed and increased with an appropriate exercise programme. Several tests are available to assess exercise capacity. The cardiopulmonary exercise test (CPET) is the gold standard method for measuring exercise capacity. However, due to its high cost, the need for qualified personnel and complex equipment, it cannot be used in every clinic. Therefore, field tests have been developed to assess functional 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. If this is known, clinicians and researchers will interpret this exercise test more carefully, and its use in individuals with PAD will become more effective. Therefore, 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. A minimum of 24 individuals with PAD will be included in the study. Patients' demographic and clinical information will be recorded. Pulmonary function (spirometry), PAD classification (Fonteine classification and Rutherford classification), and comorbidity (Charlson Comorbidity Index) will be assessed and recorded. The gold standard methods for assessing exercise capacity for structural validity, CPET and the 6-minute walk test (6 MWT), will be performed. For reliability, 6 MST will administered a second time at 24-hour intervals. Arterial stiffness (pulse wave analysis and brachial and aortic pulse wave velocity), muscle oxygenation (near-infrared spectrometer), peripheral muscle strength (dynamometer), static balance (Kinvent PLATES v3), dynamic balance (timed up and go test), intermittent claudication (Walking Impairment Questionnaire and Borg Scale) will assessed. The results will be analysed and interpreted using appropriate statistical analysis methods.

Primary outcome measures

• 6-minute Stepper Test [Time frame: Trough study completion, an average of 1 year]
• Cardiopulmonary Exercise Test [Time frame: Trough study completion, an average of 1 year]
• 6-minute Walk Test [Time frame: Trough study completion, an average of 1 year]

Secondary outcome measures (12)

• Pulmonary function test [Time frame: Trough study completion, an average of 1 year]
• Classification Systems for Peripheral Artery Disease [Time frame: Trough study completion, an average of 1 year]
• Charlson Comorbidity Index [Time frame: Trough study completion, an average of 1 year]
• Arterial Stiffness [Time frame: Trough study completion, an average of 1 year]
• Peripheral Muscle Oxygenation [Time frame: Trough study completion, an average of 1 year]
• Peripheral Muscle Strength [Time frame: Trough study completion, an average of 1 year]
• Static Balance [Time frame: Trough study completion, an average of 1 year]
• Dynamic Balance [Time frame: Trough study completion, an average of 1 year]
• Walking Impairment Questionnaire (WIQ) [Time frame: Trough study completion, an average of 1 year]
• Intermittent Claudication [Time frame: Trough study completion, an average of 1 year]
• Dyspnea Perception [Time frame: Trough study completion, an average of 1 year]
• Fatigue Perception [Time frame: Trough study completion, an average of 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Case-only

Study locations

Turkey (Türkiye) · 1 center

• Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitatio — Ankara

Publications

• Schieber MN, Hasenkamp RM, Pipinos II, Johanning JM, Stergiou N, DeSpiegelaere HK, Chien JH, Myers SA. Muscle strength and control characteristics are altered by peripheral artery disease. J Vasc Surg. 2017 Jul;66(1):178-186.e12. doi: 10.1016/j.jvs.2017.01.051. PMID 28647034
• Gohil RA, Mockford KA, Mazari F, Khan J, Vanicek N, Chetter IC, Coughlin PA. Balance impairment, physical ability, and its link with disease severity in patients with intermittent claudication. Ann Vasc Surg. 2013 Jan;27(1):68-74. doi: 10.1016/j.avsg.2012.05.005. Epub 2012 Oct 18. PMID 23084732
• Parmenter BJ, Dieberg G, Smart NA. Exercise training for management of peripheral arterial disease: a systematic review and meta-analysis. Sports Med. 2015 Feb;45(2):231-44. doi: 10.1007/s40279-014-0261-z. PMID 25230780
• Collins EG, McBurney C, Butler J, Jelinek C, O'Connell S, Fritschi C, Reda D. The Effects of Walking or Walking-with-Poles Training on Tissue Oxygenation in Patients with Peripheral Arterial Disease. Int J Vasc Med. 2012;2012:985025. doi: 10.1155/2012/985025. Epub 2012 Sep 25. PMID 23050152
• Catalano M, Scandale G, Carzaniga G, Cinquini M, Minola M, Dimitrov G, Carotta M. Increased aortic stiffness and related factors in patients with peripheral arterial disease. J Clin Hypertens (Greenwich). 2013 Oct;15(10):712-6. doi: 10.1111/jch.12167. Epub 2013 Jul 16. PMID 24088278
• Durukan BN, Ozcan EB, Saglam M, Sener YZ, Vardar-Yagli N, Ince DI, Tokgozoglu L, Calik-Kutukcu E. Validity and reliability of the 6-min stepper test in hypertensive individuals. J Hypertens. 2025 May 1;43(5):880-886. doi: 10.1097/HJH.0000000000003996. Epub 2025 Mar 5. PMID 40079829
• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. PMID 12091180
• American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available. PMID 12524257

Identifiers

NCT: NCT07169045 · 2025 - 1240

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗