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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Monocentric and Multidisciplinary Study of the Effects of an Intensive Rehabilitation by Interval Training With Active Recovery in Peripheral Arterial Disease With Claudication

Conditions
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Peripheral Arterial Disease, Claudication

Intervention / Treatment
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* Procedure: experimental rehabilitation program
* Procedure: conventional rehabilitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional rehabilitation program<br>conventional rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with complete rest. | Procedure: conventional rehabilitation program<br>* 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.<br>|
| Experimental: experimental rehabilitation program<br>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<br>* 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. Week 2 Walking speed = average of the walking speeds done on week 1 Walking slope = 1% Recovery slope = 0% Increase of the slope = 0.5% after each training without pain. Week 3 Walking speed = 70% of the maximal walking test's speed Recovery speed = 40 % of the maximal walking test's speed Slope = average of the slopes done on week 2 Increase of the speed = 0.1 km/h . Week 4 Speeds = average of the walking speeds done on week 3 Walking slope = 1% Recovery slope = 0% Increase of the slope is 0.5% .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery | Change in walking distance between day 0 and day 28, measured on a graded treadmill test | Between day 0 and day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation. | 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 | Between day 0 and day 28 | 
| Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation. | 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 | Between day 0 and day 28 | 
| One year follow-up | 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. | one year | 
| Reproducibility test of the walking graduated treadmill | 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. | Day 0 et day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Assessment, Rehabilitation, Walking Constant Test, Walking Graded test, Six minute Walking test, Walking Distance