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

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ClinicalTrials.gov Identifier: NCT01734603
Recruitment Status : Completed
First Posted : November 27, 2012
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Study Description
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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).


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Claudication Procedure: experimental rehabilitation program Procedure: conventional rehabilitation program Phase 3

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 Design
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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

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Arms and Interventions
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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.

  • 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% .


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Handicap and Depression measures [ Time Frame: Between day 0 and day 28 ]
    • Walking Impairment Questionary WIQ
    • Hospital Anxiety and Depression Scale HADS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
France
CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation
Echirolles, France, 38434
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:
Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. Review.

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