Intensive Rehabilitation in Peripheral Arterial Disease With Claudication: Effects of a Treadmill Training With Active Recovery (ARTEX)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01734603 |
Recruitment Status
:
Completed
First Posted
: November 27, 2012
Last Update Posted
: June 25, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peripheral Arterial Disease Claudication | Procedure: experimental rehabilitation program Procedure: conventional rehabilitation program | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | October 2011 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | September 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: conventional rehabilitation program
conventional rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with complete rest.
|
Procedure: conventional rehabilitation program
Duration of the training 40 minutes (time excluding rest and warm up) Initial intensity = 3.2 km per hour and slope at 0% Walking until pain 3/5, then stop until pain completely subsides.Resume of walking as soon as possible. Increase : Week 1: if the walking is possible during 8 minutes, increase of the slope of 0.5% in each training until 10% Week 2 :if the walking is possible during 8 minutes, increase of the speed 0.2 mile per hour until 3 mph Week 3 :if the walking is possible during 8 minutes, increase of the slope 2% at each training until 15% Week 4 : if the walking is possible during 8 minutes, increase the speed 0.2mph at each training as long as it is possible. |
Experimental: experimental rehabilitation program
experimental rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with active recovery (no stop walking).
|
Procedure: experimental rehabilitation program
Duration training = 40 min : 5 cycles of 6 min each Week 1 speed of the walking exercise fixed at 70% of the max walking test's speed done on the initial walking test speed of the walking recovery fixed at 40% Walking slope : 0% Increase of the speed = 0.1 km/h after each training without pain.
|
- Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery [ Time Frame: Between day 0 and day 28 ]Change in walking distance between day 0 and day 28, measured on a graded treadmill test
- Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation. [ Time Frame: Between day 0 and day 28 ]
- Change in walking distance between day 0 and day 28, measured with the 6 MWT and the Strandness test.
- 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
- Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Handicap and Depression measures [ Time Frame: Between day 0 and day 28 ]
- Walking Impairment Questionary WIQ
- Hospital Anxiety and Depression Scale HADS

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734603
France | |
CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation | |
Echirolles, France, 38434 |
Principal Investigator: | Béatrice VILLEMUR, MD | Unité de rééducation vasculaire - Clinique médecine physique de rééducation - CHU Grenoble - Hôpital Sud | |
Study Chair: | Dominic Perennou, MD, PhD | Rehabilitation Department, Universitary Hospital Grenoble |
Publications:
Responsible Party: | University Hospital, Grenoble |
ClinicalTrials.gov Identifier: | NCT01734603 History of Changes |
Other Study ID Numbers: |
DCIC 12 |
First Posted: | November 27, 2012 Key Record Dates |
Last Update Posted: | June 25, 2015 |
Last Verified: | June 2015 |
Keywords provided by University Hospital, Grenoble:
Assessment Rehabilitation Walking Constant Test |
Walking Graded test Six minute Walking test Walking Distance |
Additional relevant MeSH terms:
Peripheral Arterial Disease Peripheral Vascular Diseases Intermittent Claudication Atherosclerosis Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Signs and Symptoms |