The objective of this study was to evaluate whether a new simple isometric near infrared spectroscopy (NIRS) foot pedal test of lower leg muscles could be used for functional testing of patients suffering from peripheral arterial disease (PAD) in a daily clinical setting as an alternative to the treadmill test now being used. In a comparison of the new test and the existing treadmill test, we applied NIRS recording in both tests. We hypothesized that a pedal test would have an equal or better reproducibility than a standard treadmill test because the pedal test was designed to reduce factors that influence the reproducibility.The diagnosis and clinical staging of PAD is currently based on patient symptoms of muscle ischemia combined with ankle blood pressure (ankle brachial index [ABI]),
Keywords► near infrared spectroscopy ► peripheral arterial disease ► reproducibility of test measurements ► pedal ergometry ► treadmill ► dynamic and isometric exercise test
AbstractBackground The study aims to test a new, simple, and reliable apparatus and procedure for the diagnostics and treatment evaluation of peripheral arterial disease (PAD). The test apparatus involves near infrared spectroscopy (NIRS) of a main part of the lower leg muscles during isometric flexion and extension of the ankle joint performed with the foot strapped in a specially designed pedal ergometer. Design To evaluate the reproducibility of the new test compared with an existing testing method of treadmill walking. Methods Eleven patients participated in the study: nine patients with claudication and two age-matched patients without claudication. Each patient was tested with an isometric ergometer pedal test and a treadmill test applying NIRS measurements of the anterior tibial and the gastrocnemius muscles (GAS). Tests were repeated three times with randomly selected intervals between individual test runs. Intraclass correlation constant (ICC) was used to describe reproducibility. The ICC was calculated using the area under the NIRS oxygenated hemoglobin (Hb ox ) curve, the initial velocity of the Hb ox recovery curve, force measurements, and walking time.Results The ICC of the GAS was between 0.92-0.95 (foot-pedal) and 0.70-0.98 (tread mill) and of the anterior tibial muscle was between 0.87-0.96 (foot-pedal) and 0.67-0.79 (tread mill). Conclusion In this study, we contribute a new apparatus and test protocol for peripheral arterial disease (PAD) applying NIRS technique and controlled physical activity to evaluate the degree of muscle oxygenation under specific functionally relevant conditions. Thus, we have developed a clinically applicable "easy-to-do" exercise test of patients with chronic PAD which show high reproducibility.