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

Peripheral Arterial Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734603
• Other study ID #: DCIC 12
• Status: Completed
• Phase: Phase 3
• First received: November 21, 2012
• Last updated: June 24, 2015
• Start date: October 2011
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: The Commission nationale de l’informatique et des libertésFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Claudication
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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% .
• 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.

Locations

Country	Name	City	State
France	CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation	Echirolles

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Handicap and Depression measures	Walking Impairment Questionary WIQ; Hospital Anxiety and Depression Scale HADS	Between day 0 and day 28	No
Primary	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	No
Secondary	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	Between day 0 and day 28	Yes
Secondary	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	Between day 0 and day 28	Yes
Secondary	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.	one year	Yes
Secondary	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.	Day 0 et day 1	No