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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients With Peripheral Artery Disease |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary function test | Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), FEV1/FVC, peak expiratory flow rate (PEF), and flow rate 25-75% of forced expiratory volume (FEV25-75%) will be measured. |
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Inclusion Criteria:
Exclusion Criteria:
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24 patients diagnosed with peripheral artery disease will be recruited
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meral BOŞNAK GÜÇLÜ | Contact | +90(312)2162647 | merakbosnak@gazi.edu.tr | |
| Beyza BEKDEMİR | Contact | +90(554)8394211 | beyzabekdemir.bb@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Beyza BEKDEMİR | Gazi University | Study Chair |
| Nihan KATAYIFÇI | Gazi University | Principal Investigator |
| Abdullah ÖZER |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit | Recruiting | Ankara | Çankaya | 06490 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28647034 | Background | 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. | |
| 23084732 | 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. |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Trough study completion, an average of 1 year |
| Classification Systems for Peripheral Artery Disease | It will be performed using the Fontaine and Rutherford classification systems. According to the Fontaine classification system, peripheral arterial disease in individuals is assessed as stage I: asymptomatic disease, stage Ia: mild claudication, stage Ib: moderate-severe claudication, stage II: pain at rest, stage IV: ulceration or gangrene. According to the Rutherford classification system, it is classified as follows: 0: Asymptomatic, 1: Mild claudication, 2: Moderate claudication, 3: Severe claudication, 4: Ischemic rest pain, 5: Minor tissue loss, 6: Major tissue loss. | Trough study completion, an average of 1 year |
| Charlson Comorbidity Index | This index identifies and defines 19 comorbid chronic diseases accompanying patients' primary diseases and determines the mortality risk. The total score obtained from the index ranges from 0 to 37. | Trough study completion, an average of 1 year |
| Arterial Stiffness | Arterial stiffness will be assessed using the SphygmoCor® XCEL device. The patient's peripheral blood pressure will be measured by partially inflating the cuff on the brachial artery. Then, to assess carotid PWV, carotid pulse waves will be measured with a tonometer. A cuff will be placed on the femoral area to measure femoral PWV. The device will measure carotid-femoral artery PWV, pulse transit time, augmented index (Aix) values. | Trough study completion, an average of 1 year |
| Peripheral Muscle Oxygenation | CPET and the second time applied 6 MST before, during, and recovery, the patients' dominant side gastrocnemius and quadriceps femoris muscles' oxygen percentage (SmO2%), oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb) levels, the difference between O2Hb and HHb (HbDiff), and total haemoglobin concentration (THb) levels will be measured using a near-infrared spectrometer (NIRS) device. | Trough study completion, an average of 1 year |
| Peripheral Muscle Strength | Patients' knee extensor and plantar flexor muscle strength will be assessed using the Kinvent K-Push dynamometer. | Trough study completion, an average of 1 year |
| Static Balance | Static balance assessment will be performed using Kinvent PLATES v3. On the PLATES, with eyes open and closed, three repetitions will be performed first on double leg and then single leg. The average of the three tests will be used for analysis. | Trough study completion, an average of 1 year |
| Dynamic Balance | Dynamic balance will be assessed using the timed up and go test. The duration will be recorded in seconds. The test will be repeated three times, and the best time will be used in the analysis. | Trough study completion, an average of 1 year |
| Walking Impairment Questionnaire (WIQ) | The 21-item 'Walking Impairment Questionnaire (WIQ)' developed by Regensteiner et al. (1995) will be used in its Turkish adaptation. WIQ consists of the parameters of claudication, differential diagnosis, walking distance, walking speed, and the ability to climb stairs. A high score indicates high performance. | Trough study completion, an average of 1 year |
| Intermittent Claudication | Intermittent claudication will recorded using the modified Borg scale. The total number of steps at the end of the 6 MST, the time when claudication pain began, the number of steps at which claudication pain began, the duration of the test in minutes, and whether absolute claudication pain was present will recorded. The onset time and distance of intermittent claudication and absolute claudication will be recorded in the CPET and 6 MWT tests. | Trough study completion, an average of 1 year |
| Dyspnea Perception | Dyspnea perception will be measured with Modified Borg Scale. The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath. before, during, and after the The perception of dyspnea will be assessed before, during, and recovery of the 6 MST, CPET, and 6 MWT. | Trough study completion, an average of 1 year |
| Fatigue Perception | Fatigue perception will be evaluated with Modified Borg Scale. The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means fatigue. The perception of fatigue will be assessed before, during, and recovery of the 6 MST, CPET, and 6 MWT. | Trough study completion, an average of 1 year |
| Gazi University |
| Principal Investigator |
| Meral BOŞNAK GÜÇLÜ | Gazi University | Study Director |
|
| 25230780 | Result | 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. |
| 23050152 | 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. |
| 24088278 | 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. |
| 40079829 | 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. |
| 12091180 | 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. |
| 12524257 | 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. |
| 20053721 | 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. |
| 28886620 | 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. |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |