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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | Other | 160 men and women with PAD will be recruited. |
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| Control session | Other | 40 patients (men and women) will complete this session. |
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| Exercise session | Other | 40 patients (men and women) will complete this session. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention (Observational study) | Other | 160 patients will be recruited to:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Cross-sectional study. This outcome will be measured through study completion, an average of 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Gender-specific differences in physical activity level measured by accelerometer | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Veronique Cornelissen, PhD | Contact | 003216329152 | veronique.cornelissen@kuleuven.be |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Control session | Other | 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. |
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| Exercise session | Other | 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. |
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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.
| 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. | Cross-sectional study. This outcome will be measured through study completion, an average of 18 months. |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |