Peripheral Arterial Disease Clinical Trial
— ARTEXOfficial 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
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).
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation | Echirolles |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Handicap and Depression measures | Walking Impairment Questionary WIQ Hospital Anxiety and Depression Scale HADS |
Between day 0 and day 28 | No |
Primary | 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 | No |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | Yes |
Secondary | 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 | No |
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