Clinical trial NCT01734603: Intensive Rehabilitation in Peripheral Arterial Disease With Claudication: Effects of a Treadmill Training With Active Recovery
Official title: Randomized, Monocentric and Multidisciplinary Study of the Effects of an Intensive Rehabilitation by Interval Training With Active Recovery in Peripheral Arterial Disease With Claudication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Arterial Disease
Claudication
Keywords: Assessment
Rehabilitation
Walking Constant Test
Walking Graded test
Six minute Walking test
Walking Distance
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery
timeFrame: Between day 0 and day 28
Secondary outcomes:
measure: Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.
timeFrame: Between day 0 and day 28
measure: Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.
timeFrame: Between day 0 and day 28
measure: One year follow-up
timeFrame: one year
measure: Reproducibility test of the walking graduated treadmill
timeFrame: Day 0 et day 1
Other outcomes:
measure: Handicap and Depression measures
timeFrame: Between day 0 and day 28
Locations:
city: Echirolles
country: France
facility: CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation
Study officials:
affiliation: Unité de rééducation vasculaire - Clinique médecine physique de rééducation - CHU Grenoble - Hôpital Sud
name: Béatrice VILLEMUR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehabilitation Department, Universitary Hospital Grenoble
name: Dominic Perennou, MD, PhD
role: STUDY_CHAIR
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