Peripheral Arterial DiseasePhase 3ARTEXNCT01734603
Intensive Rehabilitation in Peripheral Arterial Disease With Claudication: Effects of a Treadmill Training With Active Recovery
A Phase 3 study testing experimental rehabilitation program and conventional rehabilitation program in people with Peripheral Arterial Disease and Claudication, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Claudication
- What is being tested?
- experimental rehabilitation program and conventional rehabilitation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Sep 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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
Who cannot join
- Impossibility to perform protocol whatever reason
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Grenoble - Hôpital Sud - Clinique médecine physique de rééducation
Échirolles, 38434
About this study
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
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).
Read the 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.
- Conditions
- Peripheral Arterial Disease, Claudication
- Being tested
- experimental rehabilitation program, conventional rehabilitation program
- Keywords
- Assessment, Rehabilitation, Walking Constant Test, Walking Graded test, Six minute Walking test, Walking Distance
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental rehabilitation programProcedure or surgery
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 programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| conventional rehabilitation program | Active comparator | conventional rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with complete rest. Receives: 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). Receives: Procedure: experimental rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Between day 0 and day 28
Secondary outcomes (4)
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
Measured: Between day 0 and day 28
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
Measured: Between day 0 and day 28
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.
Measured: one year
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.
Measured: Day 0 et day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Béatrice VILLEMUR, MD, Principal investigator, Unité de rééducation vasculaire - Clinique médecine physique de rééducation - CHU Grenoble - Hôpital SudDominic Perennou, MD, PhD, Study chair, Rehabilitation Department, Universitary Hospital Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01734603
- Sponsor's protocol ID
- DCIC 12
- Acronym
- ARTEX
- Status last verified
- Jun 2015
- First submitted
- 21 Nov 2012
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Villemur B, Marquer A, Gailledrat E, Benetreau C, Bucci B, Evra V, Rabeau V, De Angelis MP, Bouchet JY, Carpentier P, Perennou D. New rehabilitation program for intermittent claudication: Interval training with active recovery: pilot study. Ann Phys Rehabil Med. 2011 Jul;54(5):275-81. doi: 10.1016/j.rehab.2011.05.003. Epub 2011 Jun 12. English, French.
PubMed 21704582Tisi PV, Hulse M, Chulakadabba A, Gosling P, Shearman CP. Exercise training for intermittent claudication: does it adversely affect biochemical markers of the exercise-induced inflammatory response? Eur J Vasc Endovasc Surg. 1997 Nov;14(5):344-50. doi: 10.1016/s1078-5884(97)80283-3.
PubMed 9413374Strandness DE Jr. Exercise testing in the evaluation of patients undergoint direct arterial surgery. J Cardiovasc Surg (Torino). 1970 May-Jun;11(3):192-200. No abstract available.
PubMed 5470199Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997 Mar;27(2):363-70. doi: 10.1017/s0033291796004382.
PubMed 9089829Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662Nicolai SP, Viechtbauer W, Kruidenier LM, Candel MJ, Prins MH, Teijink JA. Reliability of treadmill testing in peripheral arterial disease: a meta-regression analysis. J Vasc Surg. 2009 Aug;50(2):322-9. doi: 10.1016/j.jvs.2009.01.042.
PubMed 19631868Meijer WT, Hoes AW, Rutgers D, Bots ML, Hofman A, Grobbee DE. Peripheral arterial disease in the elderly: The Rotterdam Study. Arterioscler Thromb Vasc Biol. 1998 Feb;18(2):185-92. doi: 10.1161/01.atv.18.2.185.
PubMed 9484982McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962.
PubMed 19141764Le Faucheur A, Abraham P, Jaquinandi V, Bouye P, Saumet JL, Noury-Desvaux B. Measurement of walking distance and speed in patients with peripheral arterial disease: a novel method using a global positioning system. Circulation. 2008 Feb 19;117(7):897-904. doi: 10.1161/CIRCULATIONAHA.107.725994. Epub 2008 Feb 4.
PubMed 18250268Lechat P, Priollet P. [Prevention of major ischemic events in lower limb arterial disease: does aspirin play a role?]. J Mal Vasc. 2006 Jul;31(3):129-34. doi: 10.1016/s0398-0499(06)76531-3. French.
PubMed 16840949Kruidenier LM, Nicolai SP, Hendriks EJ, Bollen EC, Prins MH, Teijink JA. Supervised exercise therapy for intermittent claudication in daily practice. J Vasc Surg. 2009 Feb;49(2):363-70. doi: 10.1016/j.jvs.2008.09.042. Epub 2008 Nov 22.
PubMed 19028059Hirsch 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. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
PubMed 16549646Harvey SB, Hotopf M, Overland S, Mykletun A. Physical activity and common mental disorders. Br J Psychiatry. 2010 Nov;197(5):357-64. doi: 10.1192/bjp.bp.109.075176.
PubMed 21037212Montgomery PS, Gardner AW. The clinical utility of a six-minute walk test in peripheral arterial occlusive disease patients. J Am Geriatr Soc. 1998 Jun;46(6):706-11. doi: 10.1111/j.1532-5415.1998.tb03804.x.
PubMed 9625185Gardner AW, Skinner JS, Smith LK. Effects of handrail support on claudication and hemodynamic responses to single-stage and progressive treadmill protocols in peripheral vascular occlusive disease. Am J Cardiol. 1991 Jul 1;68(1):99-105. doi: 10.1016/0002-9149(91)90719-2.
PubMed 2058566
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01734603
- Acronym / sponsor ID
- ARTEX / DCIC 12
- Conditions
- Peripheral Arterial Disease, Claudication
- Keywords
- Assessment, Rehabilitation, Walking Constant Test, Walking Graded test, Six minute Walking test, Walking Distance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 27 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional rehabilitation program | Active comparator | Procedure: conventional rehabilitation programconventional rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with complete rest. |
| experimental rehabilitation program | Experimental | Procedure: experimental rehabilitation programexperimental rehabilitation program 20 patients are expected in this arm. Patients perform walking treadmill exercises with active recovery (no stop walking). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (1 listed)
- Impossibility to perform protocol whatever reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental rehabilitation programDuration 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% . | Procedure or surgery | experimental rehabilitation program |
| conventional rehabilitation programDuration 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. | Procedure or surgery | conventional rehabilitation program |
Primary outcome
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
4 secondary outcomes
Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.
Time frame: Between day 0 and day 28
Determine vascular and respiratory parameters which participate to improve the walking abilities after rehabilitation.
Time frame: Between day 0 and day 28
One year follow-up
Time frame: one year
Reproducibility test of the walking graduated treadmill
Time frame: Day 0 et day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Background: PubMed 21704582Villemur B, Marquer A, Gailledrat E, Benetreau C, Bucci B, Evra V, Rabeau V, De Angelis MP, Bouchet JY, Carpentier P, Perennou D. New rehabilitation program for intermittent claudication: Interval training with active recovery: pilot study. Ann Phys Rehabil Med. 2011 Jul;54(5):275-81. doi: 10.1016/j.rehab.2011.05.003. Epub 2011 Jun 12. English, French.
- Background: PubMed 9413374Tisi PV, Hulse M, Chulakadabba A, Gosling P, Shearman CP. Exercise training for intermittent claudication: does it adversely affect biochemical markers of the exercise-induced inflammatory response? Eur J Vasc Endovasc Surg. 1997 Nov;14(5):344-50. doi: 10.1016/s1078-5884(97)80283-3.
- Background: PubMed 5470199Strandness DE Jr. Exercise testing in the evaluation of patients undergoint direct arterial surgery. J Cardiovasc Surg (Torino). 1970 May-Jun;11(3):192-200. No abstract available.
- Background: PubMed 9089829Spinhoven P, Ormel J, Sloekers PP, Kempen GI, Speckens AE, Van Hemert AM. A validation study of the Hospital Anxiety and Depression Scale (HADS) in different groups of Dutch subjects. Psychol Med. 1997 Mar;27(2):363-70. doi: 10.1017/s0033291796004382.
- Background: PubMed 12914662Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Background: PubMed 19631868Nicolai SP, Viechtbauer W, Kruidenier LM, Candel MJ, Prins MH, Teijink JA. Reliability of treadmill testing in peripheral arterial disease: a meta-regression analysis. J Vasc Surg. 2009 Aug;50(2):322-9. doi: 10.1016/j.jvs.2009.01.042.
- Background: PubMed 9484982Meijer WT, Hoes AW, Rutgers D, Bots ML, Hofman A, Grobbee DE. Peripheral arterial disease in the elderly: The Rotterdam Study. Arterioscler Thromb Vasc Biol. 1998 Feb;18(2):185-92. doi: 10.1161/01.atv.18.2.185.
- Background: PubMed 19141764McDermott MM, Ades P, Guralnik JM, Dyer A, Ferrucci L, Liu K, Nelson M, Lloyd-Jones D, Van Horn L, Garside D, Kibbe M, Domanchuk K, Stein JH, Liao Y, Tao H, Green D, Pearce WH, Schneider JR, McPherson D, Laing ST, McCarthy WJ, Shroff A, Criqui MH. Treadmill exercise and resistance training in patients with peripheral arterial disease with and without intermittent claudication: a randomized controlled trial. JAMA. 2009 Jan 14;301(2):165-74. doi: 10.1001/jama.2008.962.
- Background: PubMed 18250268Le Faucheur A, Abraham P, Jaquinandi V, Bouye P, Saumet JL, Noury-Desvaux B. Measurement of walking distance and speed in patients with peripheral arterial disease: a novel method using a global positioning system. Circulation. 2008 Feb 19;117(7):897-904. doi: 10.1161/CIRCULATIONAHA.107.725994. Epub 2008 Feb 4.
- Background: PubMed 16840949Lechat P, Priollet P. [Prevention of major ischemic events in lower limb arterial disease: does aspirin play a role?]. J Mal Vasc. 2006 Jul;31(3):129-34. doi: 10.1016/s0398-0499(06)76531-3. French.
- Background: PubMed 19028059Kruidenier LM, Nicolai SP, Hendriks EJ, Bollen EC, Prins MH, Teijink JA. Supervised exercise therapy for intermittent claudication in daily practice. J Vasc Surg. 2009 Feb;49(2):363-70. doi: 10.1016/j.jvs.2008.09.042. Epub 2008 Nov 22.
- Background: PubMed 16549646Hirsch 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. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Béatrice VILLEMUR, MD principal investigator
Unité de rééducation vasculaire - Clinique médecine physique de rééducation - CHU Grenoble - Hôpital Sud
Dominic Perennou, MD, PhD study chair
Rehabilitation Department, Universitary Hospital Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing experimental rehabilitation program and conventional rehabilitation program in people with Peripheral Arterial Disease and Claudication, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive Rehabilitation in Peripheral Arterial Disease with Claudication: effects of a treadmill training with active recovery (time frame: Between day 0 and day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01734603, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.