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

Primary Purpose

Peripheral Arterial Disease, Claudication

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
experimental rehabilitation program
conventional rehabilitation program
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Assessment, Rehabilitation, Walking Constant Test, Walking Graded test, Six minute Walking test, Walking Distance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional rehabilitation program

experimental rehabilitation program

Arm Description

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

experimental rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with active recovery (no stop walking).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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.
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.

Full Information

First Posted
November 21, 2012
Last Updated
June 24, 2015
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01734603
Brief Title
Intensive Rehabilitation in Peripheral Arterial Disease With Claudication: Effects of a Treadmill Training With Active Recovery
Acronym
ARTEX
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Claudication
Keywords
Assessment, Rehabilitation, Walking Constant Test, Walking Graded test, Six minute Walking test, Walking Distance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional rehabilitation program
Arm Type
Active Comparator
Arm Description
conventional rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with complete rest.
Arm Title
experimental rehabilitation program
Arm Type
Experimental
Arm Description
experimental rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with active recovery (no stop walking).
Intervention Type
Procedure
Intervention Name(s)
experimental rehabilitation program
Intervention Description
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% .
Intervention Type
Procedure
Intervention Name(s)
conventional rehabilitation program
Intervention Description
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 Outcome Measure Information:
Title
Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery
Description
Change in walking distance between day 0 and day 28, measured on a graded treadmill test
Time Frame
Between day 0 and day 28
Secondary Outcome Measure Information:
Title
Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.
Description
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
Time Frame
Between day 0 and day 28
Title
Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.
Description
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
Time Frame
Between day 0 and day 28
Title
One year follow-up
Description
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.
Time Frame
one year
Title
Reproducibility test of the walking graduated treadmill
Description
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.
Time Frame
Day 0 et day 1
Other Pre-specified Outcome Measures:
Title
Handicap and Depression measures
Description
Walking Impairment Questionary WIQ Hospital Anxiety and Depression Scale HADS
Time Frame
Between day 0 and day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Béatrice VILLEMUR, MD
Organizational Affiliation
Unité de rééducation vasculaire - Clinique médecine physique de rééducation - CHU Grenoble - Hôpital Sud
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dominic Perennou, MD, PhD
Organizational Affiliation
Rehabilitation Department, Universitary Hospital Grenoble
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation
City
Echirolles
ZIP/Postal Code
38434
Country
France

12. IPD Sharing Statement

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

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