Peripheral Artery Disease (PAD)NCT07169045
Validity and Reliability of the 6-minute Stepper Test in Patients With Peripheral Artery Disease
An observational study of Peripheral Artery Disease (PAD), run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Artery Disease (PAD)
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Sep 2025to 24 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 24 patients diagnosed with peripheral artery disease will be recruited
Who may be able to join
- 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.
Who cannot join
- Patients will be excluded if they have:
- Previously underwent ischaemic amputation,
- Unstable coronary artery disease,
- Uncontrolled Diabetes Mellitus,
- Pulmonary disease,
- Acute infection,
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490
Meral BOŞNAK GÜÇLÜ, +90(312)2162647, meralbosnak@gazi.edu.tr
About this study
Official title: Examination of the Validity and Reliability of 6-minute Stepper Test in Patients With Peripheral Artery Disease
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.
Read the 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.
- Conditions
- Peripheral Artery Disease (PAD)
- Keywords
- Peripheral Artery Disease, Exercise Testing, Validity and Reliability
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Peripheral Artery Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Trough study completion, an average of 1 year
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Trough study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start24 Sep 2025
- Primary completion24 Jul 2026 (estimated)
- Study completion24 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery Disease (PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Beyza BEKDEMİR, Study chair, Gazi UniversityNihan KATAYIFÇI, Principal investigator, Gazi UniversityAbdullah ÖZER, Principal investigator, Gazi UniversityMeral BOŞNAK GÜÇLÜ, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169045
- Sponsor's protocol ID
- 2025 - 1240
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28647034Gohil 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.
PubMed 23084732Parmenter 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.
PubMed 25230780Collins 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.
PubMed 23050152Catalano 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.
PubMed 24088278Durukan 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.
PubMed 40079829ATS 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.
PubMed 12091180American 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.
PubMed 12524257Borel 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.
PubMed 20053721Aboyans 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.
PubMed 28886620
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of the Validity and Reliability of 6-minute Stepper Test in Patients With Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT07169045
- Acronym / sponsor ID
- 2025 - 1240
- Conditions
- Peripheral Artery Disease (PAD)
- Keywords
- Peripheral Artery Disease, Exercise Testing, Validity and Reliability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 24 Sep 2025 (actual)
- Primary completion
- 24 Jul 2026 (estimated)
- Study completion
- 24 Jul 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients With Peripheral Artery Disease | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 24 patients diagnosed with peripheral artery disease will be recruited
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Patients will be excluded if they have:
- Previously underwent ischaemic amputation,
- Unstable coronary artery disease,
- Uncontrolled Diabetes Mellitus,
- Pulmonary disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-minute Stepper Test
Time frame: Trough study completion, an average of 1 year
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.
Cardiopulmonary Exercise Test
Time frame: Trough study completion, an average of 1 year
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.
6-minute Walk Test
Time frame: Trough study completion, an average of 1 year
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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Background: PubMed 28647034Schieber 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.
- Background: PubMed 23084732Gohil 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.
- Results publication: PubMed 25230780Parmenter 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.
- Results publication: PubMed 23050152Collins 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.
- Results publication: PubMed 24088278Catalano 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.
- Results publication: PubMed 40079829Durukan 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.
- Results publication: PubMed 12091180ATS 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.
- Results publication: PubMed 12524257American 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.
- Results publication: PubMed 20053721Borel 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.
- Results publication: PubMed 28886620Aboyans 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.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Active, not recruiting
IV-X Medical First-in-Human Peripheral Intravascular Lithotripsy Study for PAD
Peripheral Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beyza BEKDEMİR study chair
Gazi University
Nihan KATAYIFÇI principal investigator
Gazi University
Abdullah ÖZER principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease (PAD), run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meral BOŞNAK GÜÇLÜ (+90(312)2162647, merakbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute Stepper Test (time frame: Trough study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07169045, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.