Exercise in Peripheral Artery Disease (GrEnADa)

Catholic University (KU) of Leuven

Status: Unknown

Conditions: Peripheral Artery Disease; Intermittent Claudication

Treatments: Other: Exercise session; Other: Control session; Other: No intervention (Observational study)

Study type: Interventional

Funder types: Other

Identifiers

NCT02878954

13072016_Grenada

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 3 patient groups

No intervention

Other group

Description:

160 men and women with PAD will be recruited.

Treatment:

Other: No intervention (Observational study)

Other: Exercise session

Other: Control session

Control session

Other group

Description:

40 patients (men and women) will complete this session.

Treatment:

Other: Control session

Exercise session

Other group

Description:

40 patients (men and women) will complete this session.

Treatment:

Other: Exercise session