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

Phase 3

Completed

• Conditions: Peripheral Arterial Disease; Claudication

• Registration Number: NCT01734603
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Primary Completion: 2014-05
• Study Completion: 2014-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery	Between day 0 and day 28	Change in walking distance between day 0 and day 28, measured on a graded treadmill test

Secondary Outcome Measures

Name	Time	Method
Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.	Between day 0 and day 28	* Measure of ABI(Ankle-to- Brachial systolic blood pressure Index) and recovery time; * Measure of the transcutaneous oxygen pression; * Measure of the maximal cardiac frequency; * Measure of peak oxygen consumption and lactatemy
One year follow-up	one year	All patients included are invited to be assessed at a one year. Interview, Clinical Examination, and Assessemnts are performed in day hospital (half a day).; Criteria are: Patients 'satisfaction about protocole using an ad hoc ordinal scale Medical and duplex scan examinations Vascular risk factors and comorbidities Occurence of any medical event during the year Changes in WIQ and HADS changes in walking distance at the Graduated Treadmill Test.
Reproducibility test of the walking graduated treadmill	Day 0 et day 1	The fifteen last patients are invited to perform the consecutive graduated treadmill test on day 0 et day 1. Reproducibility of the walking distance assess by this novel test is quantified.

Trial Locations

Locations (1)

CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation; 🇫🇷 Echirolles, France