This research project aims to investigate the gender-based difference in patients with peripheral artery disease. To attend this, this study has two specific objectives: Objective 1: To identify gender-specific barriers towards exercise and physical activity in patients with peripheral artery disease (PAD). Objective 2: To evaluate gender-specific differences in functional capacity and cardiovascular function and regulation in patients with PAD at rest, during and following a single session of maximal exercise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
160
160 patients will be recruited to: * Fill in questionnaires related to demographic characteristics, severity of disease and physical activity. * Perform a six-minute walk test Comparison between men and women will be performed.
Out of the 160 participants of the observational study, at least 40 (20 men and 20 women) will be recruited. In the control session participants will be seated in resting position for 15 minutes.
40 patients will perform a single maximal exercise test on a treadmill. Speed will be maintained at 3.2 km/h and the grade will be increased with 2% every 2 min following Gardner's protocol.
Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.
After completion of the 6-minute walking test, patients will be asked to fill in the following questionnaires: walking impairment questionnaire, walking estimated-limitation calculated by history (WELCH), San Diego Claudication Questionnaire, SF-36 and two questionnaires for personal and environmental barriers to physical activity.
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in walk capacity in patients with peripheral artery disease
The measurements of this outcome will be performed in a second visit day, separated by at least 48h from visit 1 (outcome 1). Patients will perform a maximal exercise test to determine claudication onset distance (m) defined as the distance walked until the patients first reported pain in the leg during the treadmill test and total walk distance (m) defined as the total distance that the patient was able to walk during the test.
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in functional capacity in patients with peripheral artery disease
Walking economy defined as VO2 measured during the first stage of the treadmill test and functional capacity defined as VO2 peak obtained during the test will be obtained.
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in physical activity level measured by accelerometer
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in autonomic modulation at rest and after a maximal exercise test
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Autonomic modulation: assessed by spectral analysis of heart rate and systolic blood pressure variabilities. Heart rate (electrocardiogram) and beat-by-beat blood pressure (finometer) will be recorded for 10 min at a sample frequency of 500Hz/channel.
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test
Blood flow and blood flow response after reactive hyperemia.
Time frame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.