Examination of the Validity and Reliability of 6-minute Stepper Test in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 6-minute Stepper Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •Ages between 18 and 80,
- •Patients who volunteer to participate in the study will be included.
排除标准
- •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.
研究组 & 干预措施
Patients With Peripheral Artery Disease
结局指标
主要结局
6-minute Stepper Test
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- Static Balance(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)
- Peripheral Muscle Strength(Trough study completion, an average of 1 year)
- Dynamic Balance(Trough study completion, an average of 1 year)
- Walking Impairment Questionnaire (WIQ)(Trough study completion, an average of 1 year)
- Intermittent Claudication(Trough study completion, an average of 1 year)
- Fatigue Perception(Trough study completion, an average of 1 year)
- Dyspnea Perception(Trough study completion, an average of 1 year)
研究者
Meral Boşnak Güçlü
Study director, PT, PhD, Prof.Dr. Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Head of Cardiopulmonary Rehabilitation Clinic
Gazi University
