In this controlled trial, patients with peripheral arterial disease will be randomized to either maximal walking, submaximal walking, or usual care groups.
Exercise training (walking) is a recommended therapeutic intervention for patients with peripheral arterial disease (PAD). Studies have shown that exercise training improves walking distance, pain-free walking distance, endothelial function and quality of life in these patients. However, to date the most effective exercise training option in terms of improvement of cardiovascular parameters has not been clearly identified. In this controlled trial, patients with PAD will be randomized to either maximal walking group, submaximal walking group, or usual care. The aim of the study is to compare the effect of maximal vs. submaximal walking training programmes on i) walking ability, ii) vascular function, iii) arrhythmogenic potential, iv) parameters of inflammation, hemostasis and heart failure severity, v) health-related quality of life in individuals with PAD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Patients to be randomized to the 'maximal walking group' or 'submaximal group' will undergo exercise training sessions 3 times per week for a period of 12 weeks.
University Medical Centre Ljubljana
Ljubljana, Slovenia
Change of maximum walking distance, measured in metres
Determined by treadmill walking test.
Time frame: 3 months
Change of flow-mediated dilatation of the brachial artery, measured in %
Time frame: 3 months
Change of the arterial stiffness coefficient
Time frame: 3 months
Change of the value of blood C-reactive protein, measured in mg/l
Time frame: 3 months
Change of the value of blood fibrinogen, measured in g/l
Time frame: 3 months
Change of the value of blood D-dimer, measured in microg/l
Time frame: 3 months
Change of the value of blood N terminal-proBNP, measured in ng/l
Time frame: 3 months
Change of from-the-questionnaire-obtained quality of life, measured in points
Time frame: 3 months
Change of the ECG waves
Estimated with digital high-resolution ECG
Time frame: 3 months
Change of the heart rate variability
Estimated with digital high-resolution ECG
Time frame: 3 months
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