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NCT Number: NCT01734603

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

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).

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Claudication Intermittent Claudication Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation

Échirolles, 38434, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

experimental rehabilitation program

Procedure

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% .

conventional rehabilitation program

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Other outcomes

  1. Handicap and Depression measures

    Time frame: Between day 0 and day 28

    • Walking Impairment Questionary WIQ
    • Hospital Anxiety and Depression Scale HADS

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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

Acronym: ARTEX

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2012
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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