Effects of Combined Aerobic and Resistance Training in Patients With Intermittent Claudication

University Of Perugia

Status: Unknown

Conditions: Endothelial Dysfunction; Peripheral Arterial Disease

Treatments: Behavioral: sham exercise; Behavioral: combined aerobic and resistance physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT04302571

APE-IC1

Details and patient eligibility

About

Exercise training improves walking capacity and regional perfusion in patients with Intermittent Claudication (IC). Endothelial Progenitor Cells (EPCs) and Endothelial Microparticles (EMPs) could play an important role in this process, promoting the healing of the diseased endothelium.

The investigators are going to measure EPCs and EMPs in a group of patients with IC and in a control group of healthy individuals before a treadmill test and 2, 24, and 48 hours after the test. Subsequently, a group of IC patients will be randomly assigned to perform a 12-week home-based exercise training program.

The investigators expect a significant increase of EMPs and EPCs after acute and chronic physical activity. We expect also a correlation between the increase of EMPs and EPCs and the improvement in walking capacity. Aim of the study is to demonstrate that acutely performed aerobic exercise could be able to promote the mobilization of EMPs and EPCs in patients with IC and that endothelial progenitor cells mobilization could play a pivotal role in exercise induced improvement of walking performance and endothelial function in subjects with IC.

Enrollment: 80 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• history of stable intermittent claudication (PAD, stage II Fontaine)
• resting ankle-brachial index (ABI) <0,9 and the presence of occlusion or significant stenosis at the color-Doppler duplex ultrasound scanning

Exclusion criteria

• lower-limb ischemic rest pain or gangrene (Fontaine stages III and IV)
• inability to obtain the ABI value or to perform a walking test
• exercise tolerance limited by factors other than claudication (i.e., arrhythmias, cardiac symptoms or exaggerated blood pressure rise, severe obesity)
• end-stage liver or renal failure
• acute or chronic inflammatory conditions
• history of recent (<6 months) acute coronary syndrome, cerebrovascular event or inducible myocardial ischemia
• treatment with drugs known to affect walking capacity, including calcium-channel blockers, β-blockers and angiotensin-converting enzyme inhibitors.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 3 patient groups

Healthy control

No Intervention group

Description:

Voluntary subjects without peripheral arterial disease

IC patients, no exercise

Sham Comparator group

Description:

Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, given advices to perform regular aerobic activity

Treatment:

Behavioral: sham exercise

IC patients, exercise

Active Comparator group

Description:

Patients with peripheral arterial disease stage II (intermittent claudication) on best medical treatment, home-based combined physical exercise

Treatment:

Behavioral: combined aerobic and resistance physical activity