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

NCT07169045 | Recruiting

• 1 other identifier: 2025 - 1240
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease (PAD)

Keywords

Peripheral Artery Disease; Exercise Testing; Validity and Reliability

Outcome Measures

Primary Outcomes (3)

• 6-minute Stepper Test

  The test will performed using the previously defined Borel et al. criteria and the adaptation of the ATS/ERS 6 MWT criteria. For the test, a standard resistance 'Stepper' device will used, positioned 20 cm above the ground. To enable the patient to receive support if they lose their balance, the stepper device will placed 10 cm away from a straight wall edge. Patients will asked to take as many steps as possible during 6 minutes. The test will be conducted for 2 minutes first for the patient to learn, and then 6 minutes of testing will be conducted after a 3-minute rest period. 6 MST will be re-applied to patients 24 hours later using the same protocol for reliability analysis.

  Trough study completion, an average of 1 year

• Cardiopulmonary Exercise Test

  CPET is the gold standard method used to assess maximal exercise capacity. For this reason, 6 MST will used to examine structural validity. CPET will be performed using a gradually increasing workload protocol with breath-by-breath measurement on a treadmill. Electrocardiography (ECG) assessment during the test will be performed using a 12-lead ECG trace. Oxygen consumption and metabolic equivalent will be measured.

  Trough study completion, an average of 1 year

• 6-minute Walk Test

  The 6 MWT is a valid and reliable submaximal exercise test for patients with peripheral arterial disease. 6 MWT will be applied to examine the structural validity of 6 MST. It will be carried out in accordance with ATS criteria.The walking distance will be recorded in two ways: in metres and as a percentage of the expected walking distance.

  Trough study completion, an average of 1 year

Secondary Outcomes (12)

• Pulmonary function test

  Trough study completion, an average of 1 year

• Classification Systems for Peripheral Artery Disease

  Trough study completion, an average of 1 year

• Charlson Comorbidity Index

  Trough study completion, an average of 1 year

• Arterial Stiffness

  Trough study completion, an average of 1 year

• Peripheral Muscle Oxygenation

  Trough study completion, an average of 1 year

Study Arms (1)

Patients With Peripheral Artery Disease

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

24 patients diagnosed with peripheral artery disease will be recruited

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, Çankaya, 06490, Turkey (Türkiye)

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Borel B, Fabre C, Saison S, Bart F, Grosbois JM. An original field evaluation test for chronic obstructive pulmonary disease population: the six-minute stepper test. Clin Rehabil. 2010 Jan;24(1):82-93. doi: 10.1177/0269215509343848.

  PMID: 20053721 RESULT

• Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 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). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.

  PMID: 28886620 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Beyza BEKDEMİR

  Gazi University

  STUDY CHAIR

• Nihan KATAYIFÇI

  Gazi University

  PRINCIPAL INVESTIGATOR

• Abdullah ÖZER

  Gazi University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ

  Gazi University

  STUDY DIRECTOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ

CONTACT

+90(312)2162647; merakbosnak@gazi.edu.tr

Beyza BEKDEMİR

CONTACT

+90(554)8394211; beyzabekdemir.bb@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: September 24, 2025
• Primary Completion (Estimated): July 24, 2026
• Study Completion (Estimated): July 24, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)