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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01734603
First received: November 21, 2012
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Peripheral Arterial Disease
Claudication
Procedure: experimental rehabilitation program
Procedure: conventional rehabilitation program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery [ Time Frame: Between day 0 and day 28 ] [ Designated as safety issue: No ]
    Change in walking distance between day 0 and day 28, measured on a graded treadmill test


Secondary Outcome Measures:
  • Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation. [ Time Frame: Between day 0 and day 28 ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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:
  • Handicap and Depression measures [ Time Frame: Between day 0 and day 28 ] [ Designated as safety issue: No ]
    • Walking Impairment Questionary WIQ
    • Hospital Anxiety and Depression Scale HADS


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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% .

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734603

Contacts
Contact: Jean-Luc BOSSON, PhD 0033476765047 JLBosson@chu-grenoble.fr

Locations
France
CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation Recruiting
Echirolles, France, 38434
Contact: Béatrice VILLEMUR, MD    0033476766025    BVillemur@chu-grenoble.fr   
Sub-Investigator: Marie-Pierre DE ANGELIS, MD         
Sub-Investigator: Michel GUINOT, MD         
Sub-Investigator: Patrick CARPENTIER, MD         
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

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
Study First Received: November 21, 2012
Last Updated: October 11, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: The Commission nationale de l’informatique et des libertés
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 29, 2014