Clinical trial NCT02878954: Exercise in Peripheral Artery Disease
Official title: Exercise in Peripheral Artery Disease - Gender-specific Differences and Unexplored Opportunities in Women: the GrEnADa-project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Intermittent Claudication
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Ankle-brachial index (ABI) ≤ 0.9 in one or two legs
* Fontaine stage II of PAD
* Body mass index \<35 kg/m2
* Resting systolic blood pressure (BP) \<160 mmHg and diastolic BP \<105 mmHg
* Ability to walk at least 2min at 3.2 km/h
* Ability to undertake an incremental treadmill test
* Decrease of at least 15% in ABI after a maximal treadmill test
* Not currently engaging in any regular exercise program

Exclusion Criteria:

* Exercise induced signs of myocardial ischemia or complex ventricular arrhythmias
* Cardiovascular autonomic neuropathy
* Use of beta-blocker
* Nondihydropyridine calcium antagonists or insulin and hormone replacement therapy

Primary outcomes:
measure: Barriers towards exercise assessed by questionnaires in patients with peripheral artery disease.
timeFrame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
measure: Gender-specific differences in walk capacity in patients with peripheral artery disease
timeFrame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
measure: Gender-specific differences in functional capacity in patients with peripheral artery disease
timeFrame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Secondary outcomes:
measure: Gender-specific differences in physical activity level measured by accelerometer
timeFrame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
measure: Gender-specific differences in autonomic modulation at rest and after a maximal exercise test
timeFrame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
measure: Gender-specific differences in vascular function in patients with peripheral artery disease at rest and after a maximal exercise test
timeFrame: Cross-sectional study. This outcome will be measured through study completion, an average of 18 months.
Other outcomes:
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