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Intermittent ClaudicationEXITPADNCT00279994

(Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease

A study testing Exercise therapy, Accelerometer (PAM; Personal Activity Monitor) and Oral Exercise Therapy advise in people with Intermittent Claudication, run by Atrium Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine if supervised exercise therapy in a physiotherapeutic setting, with or without therapy feedback, is more (cost-)effective than exercise therapy based on a 'go home and walk' advice without supervision, for patients with PAD stage II (Fontaine). Read more about this study

Who is it for?
Any age
Conditions the study is for
Intermittent Claudication
What is being tested?
Exercise therapy, Accelerometer (PAM; Personal Activity Monitor) and Oral Exercise Therapy advise
How many people
300 participants
Where
1 siteNetherlands
Study dates
Dec 2005to May 2009
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • PAD stage II
  • Ankle-brachial index below 0.9
  • Maximal walking distance of 500 meters or less

Who cannot join

  • prior ET
  • previous peripheral vascular interventions
  • no insurance for physiotherapy
  • insufficient command of the Dutch language
  • serious cardiopulmonary limitations (NYHA-3-4)
  • previous amputation
  • psychiatric instability
  • other serious co-morbidity prohibiting physical training

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Atrium Medical Centre

    Heerlen, P.O.box 4446, 6401 CX

Other trials in Netherlands

About this study

Official title: Exercise Therapy in Patients With Peripheral Arterial Disease: the Costs and Effectiveness of Physiotherapeutic Supervision With or Without Therapy Feedback Versus a "go Home and Walk" Advice

The purpose of this study is to determine if supervised exercise therapy in a physiotherapeutic setting, with or without therapy feedback, is more (cost-)effective than exercise therapy based on a 'go home and walk' advice without supervision, for patients with PAD stage II (Fontaine).

Read the detailed description

Exercise therapy (ET) is considered to be the main conservative treatment for patients with intermittent claudication (IC) and is documented to be effective, especially when supervised. However, wide scale introduction of supervised ET in the Netherlands would lead to a substantial increase of health care costs compared to current practice, while the cost-effectiveness of supervised ET is uncertain. ET follows a pattern of short walking periods that induce discomfort of moderate intensity and short rest periods. The psychological, metabolic, and mechanical alterations that occur during exercise stimulate an adaptive response that ultimately reduces the symptoms. The optimal therapy regimen depends to a large extent on home-based exercises, which require discipline from the patient. Currently, the main prescription for ET for patients with IC in the Netherlands is a single 'go home and walk' advice, without supervision or follow-up. There is no evidence to support the effectiveness of this advice and compliance is low. In studies comparing the 'go home and walk' advice to supervised ET, a large advantage for supervised ET was present. The inadequate use of the main conservative treatment for peripheral arterial disease (PAD) contributes to a gradual progression of this condition, a decrease in quality of life, and an increasing number of vascular interventions. Furthermore, with adequate ET, hypertension, hypercholesterolemia, overweight, and diabetes, if present, is better regulated.

Being tested
Exercise therapy, Accelerometer (PAM; Personal Activity Monitor), Oral Exercise Therapy advise
Keywords
Intermittent claudication, Exercise therapy, Therapy feedback, Accelerometer, Physiotherapy, PAD;, peripheral arterial disease according to Fontaine stage II)
Medical subject headings
Intermittent Claudication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise therapyProcedure or surgery

  • Accelerometer (PAM; Personal Activity Monitor)Device

  • Oral Exercise Therapy adviseProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximal walking distance

Secondary outcomes (14)

  1. pain-free walking distance

  2. blood pressure

  3. fasting glucose

  4. fasting cholesterol

  5. lipids profile

  6. body weight

  7. co-morbidity

  8. vascular interventions

  9. mortality

  10. medical and non-medical costs

  11. compliance

  12. quality of life

  13. impairment

  14. complaints

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2006 (estimated)
  2. Study startDec 2005
  3. Study completionMay 2009 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00279994
Sponsor's protocol ID
945-06-252
Acronym
EXITPAD
Status last verified
May 2008
First submitted
19 Jan 2006
Last updated
9 May 2008
Results posted
No

Publications

  • Stewart KJ, Hiatt WR, Regensteiner JG, Hirsch AT. Exercise training for claudication. N Engl J Med. 2002 Dec 12;347(24):1941-51. doi: 10.1056/NEJMra021135. No abstract available.

    PubMed 12477945

  • Patterson RB, Pinto B, Marcus B, Colucci A, Braun T, Roberts M. Value of a supervised exercise program for the therapy of arterial claudication. J Vasc Surg. 1997 Feb;25(2):312-8; discussion 318-9. doi: 10.1016/s0741-5214(97)70352-5.

    PubMed 9052565

  • Savage P, Ricci MA, Lynn M, Gardner A, Knight S, Brochu M, Ades P. Effects of home versus supervised exercise for patients with intermittent claudication. J Cardiopulm Rehabil. 2001 May-Jun;21(3):152-7. doi: 10.1097/00008483-200105000-00006.

    PubMed 11409225

  • Regensteiner JG, Meyer TJ, Krupski WC, Cranford LS, Hiatt WR. Hospital vs home-based exercise rehabilitation for patients with peripheral arterial occlusive disease. Angiology. 1997 Apr;48(4):291-300. doi: 10.1177/000331979704800402.

    PubMed 9112877

  • Cheetham DR, Burgess L, Ellis M, Williams A, Greenhalgh RM, Davies AH. Does supervised exercise offer adjuvant benefit over exercise advice alone for the treatment of intermittent claudication? A randomised trial. Eur J Vasc Endovasc Surg. 2004 Jan;27(1):17-23. doi: 10.1016/j.ejvs.2003.09.012.

    PubMed 14652832

  • Degischer S, Labs KH, Hochstrasser J, Aschwanden M, Tschoepl M, Jaeger KA. Physical training for intermittent claudication: a comparison of structured rehabilitation versus home-based training. Vasc Med. 2002 May;7(2):109-15. doi: 10.1191/1358863x02vm432oa.

    PubMed 12402991

  • Brandsma JW, Robeer BG, van den Heuvel S, Smit B, Wittens CH, Oostendorp RA. The effect of exercises on walking distance of patients with intermittent claudication: a study of randomized clinical trials. Phys Ther. 1998 Mar;78(3):278-86; discussion 286-8. doi: 10.1093/ptj/78.3.278.

    PubMed 9520973

  • Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.

    PubMed 7674529

  • Leng GC, Fowler B, Ernst E. Exercise for intermittent claudication. Cochrane Database Syst Rev. 2000;(2):CD000990. doi: 10.1002/14651858.CD000990.

    PubMed 10796572

  • Bartelink ML, Stoffers HE, Biesheuvel CJ, Hoes AW. Walking exercise in patients with intermittent claudication. Experience in routine clinical practice. Br J Gen Pract. 2004 Mar;54(500):196-200.

    PubMed 15006125

  • Dormandy J, Heeck L, Vig S. The natural history of claudication: risk to life and limb. Semin Vasc Surg. 1999 Jun;12(2):123-37.

    PubMed 10777239

  • Hooi JD, Kester AD, Stoffers HE, Overdijk MM, van Ree JW, Knottnerus JA. Incidence of and risk factors for asymptomatic peripheral arterial occlusive disease: a longitudinal study. Am J Epidemiol. 2001 Apr 1;153(7):666-72. doi: 10.1093/aje/153.7.666.

    PubMed 11282794

  • Willigendael EM, Teijink JA, Bartelink ML, Boiten J, Moll FL, Buller HR, Prins MH. Peripheral arterial disease: public and patient awareness in The Netherlands. Eur J Vasc Endovasc Surg. 2004 Jun;27(6):622-8. doi: 10.1016/j.ejvs.2004.02.019.

    PubMed 15121113

  • Gardner AW, Katzel LI, Sorkin JD, Bradham DD, Hochberg MC, Flinn WR, Goldberg AP. Exercise rehabilitation improves functional outcomes and peripheral circulation in patients with intermittent claudication: a randomized controlled trial. J Am Geriatr Soc. 2001 Jun;49(6):755-62. doi: 10.1046/j.1532-5415.2001.49152.x.

    PubMed 11454114

  • McDermott MM, Liu K, O'Brien E, Guralnik JM, Criqui MH, Martin GJ, Greenland P. Measuring physical activity in peripheral arterial disease: a comparison of two physical activity questionnaires with an accelerometer. Angiology. 2000 Feb;51(2):91-100. doi: 10.1177/000331970005100201.

    PubMed 10701716

Questions about this trial

What is this clinical trial studying?

A study testing Exercise therapy, Accelerometer (PAM; Personal Activity Monitor) and Oral Exercise Therapy advise in people with Intermittent Claudication, run by Atrium Medical Center at 1 site in Netherlands.

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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 9 May 2008. 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 Netherlands. 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.

Are results available for this study?

Results are not available in the source record.

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?

maximal walking distance. 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 NCT00279994, which also lists 28 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 9 May 2008.

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