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

NCT01734603 | Completed Phase 3 DMC

• 1 other identifier: DCIC 12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease; Claudication

Keywords

Assessment; Rehabilitation; Walking Constant Test; Walking Graded test; Six minute Walking test; Walking Distance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.

  Between day 0 and day 28

• Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.

  Between day 0 and day 28

• One year follow-up

  one year

• Reproducibility test of the walking graduated treadmill

  Day 0 et day 1

Other Outcomes (1)

• Handicap and Depression measures

  Between day 0 and day 28

Study Arms (2)

conventional rehabilitation program

ACTIVE COMPARATOR

conventional rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with complete rest.

Procedure: conventional rehabilitation program

experimental rehabilitation program

EXPERIMENTAL

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

Interventions

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% .

experimental rehabilitation program

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.

conventional rehabilitation program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• Impossibility to perform protocol whatever reason

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation

Échirolles, 38434, France

Location

Related Publications (27)

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  PMID: 32272287 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Béatrice VILLEMUR, MD

  Unité de rééducation vasculaire - Clinique médecine physique de rééducation - CHU Grenoble - Hôpital Sud

  PRINCIPAL INVESTIGATOR

• Dominic Perennou, MD, PhD

  Rehabilitation Department, Universitary Hospital Grenoble

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

FR (1)