Intensive Rehabilitation in Peripheral Arterial Disease With Claudication: Effects of a Treadmill Training With Active Recovery (ARTEX)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: Claudication; Peripheral Arterial Disease

Treatments: Procedure: experimental rehabilitation program; Procedure: conventional rehabilitation program

Study type: Interventional

Funder types: Other

Identifiers

NCT01734603

DCIC 12

Details and patient eligibility

About

Rehabilitation is the first intention treatment of peripheral arterial disease (PAD) with claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to patients with PAD have recently been proved effective and defined in many guidelines. Supervised walking training on treadmill is recommended. Usually patients walk up to a mild or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then stop until pain completely subsides and walk again .

The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by alternating short sequences of intensive training and active recovery (without rest).

Full description

Fractionated mode of training with active recovery has been proved effective in sport training as well as in Cardiac rehabilitation. We hypothesized it might be also interesting in the rehabilitation of patients with a peripheral arterial disease. The active recovery period might magnified the beneficial effect of a short intensive training.

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient (male/female) between 18 and 80 years
• Patient with Fontaine stage II PAD confirmed by clinic, duplex ultrasound and ankle-to-brachial systolic blood pressure index
• Cardiac status compatible with an intensive gait rehabilitation (checked by a consultation with a cardiologist, including interview, clinical examination, electrocardiograph, and effort test on ergocycle).
• Volunteer to take part in the study, having sign the consent form after receiving sufficient information and the information leaflet
• Person affiliated to social security or the recipient of a similar scheme

Not Inclusion Criteria:

• Exercise tolerance limited by other factors than claudication (eg, coronary artery disease, dyspnea, poorly controlled blood pressure
• walking limited by other pathology
• osteoarticular lower limbs pathology
• abdominal aortic aneurysm > 4 cm
• pseudo-flu-like feverish syndromes in evolution (myocarditis or pericarditis)
• Person deprived of liberty by a legal or administrative decision, person under legal protection
• Person currently participating in a clinical trial or having taken part in a clinical trial in the month preceding inclusion
• Patient presenting with a history of mental or psychiatric illness or any other factor restricting his/her ability to participate in an informed manner and in compliance with the protocol

Exclusion criteria

Impossibility to perform protocol whatever reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

conventional rehabilitation program

Active Comparator group

Description:

conventional rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with complete rest.

Treatment:

Procedure: conventional rehabilitation program

experimental rehabilitation program

Experimental group

Description:

experimental rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with active recovery (no stop walking).

Treatment:

Procedure: experimental rehabilitation program