NCT00279994

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2006

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

First QC Date

January 19, 2006

Last Update Submit

May 6, 2008

Conditions

Intermittent Claudication

Keywords

Intermittent claudicationExercise therapyTherapy feedbackAccelerometerPhysiotherapyPAD;peripheral arterial disease according to Fontaine stage II)

Outcome Measures

Primary Outcomes (1)

  • maximal walking distance

Secondary Outcomes (14)

  • pain-free walking distance

  • blood pressure

  • fasting glucose

  • fasting cholesterol

  • lipids profile

  • +9 more secondary outcomes

Interventions

Exercise therapyPROCEDURE
Accelerometer (PAM; Personal Activity Monitor)DEVICE
Oral Exercise Therapy advisePROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Medical Centre

Heerlen, P.O.box 4446, 6401 CX, Netherlands

Location

Related Publications (28)

  • 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.

    PMID: 12477945BACKGROUND

  • 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.

    PMID: 9052565BACKGROUND

  • 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.

    PMID: 11409225BACKGROUND

  • 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.

    PMID: 9112877BACKGROUND

  • 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.

    PMID: 14652832BACKGROUND

  • 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.

    PMID: 12402991BACKGROUND

  • 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.

    PMID: 9520973BACKGROUND

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

    PMID: 7674529BACKGROUND

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

    PMID: 10796572BACKGROUND

  • 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.

    PMID: 15006125BACKGROUND

  • 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.

    PMID: 10777239BACKGROUND

  • 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.

    PMID: 11282794BACKGROUND

  • 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.

    PMID: 15121113BACKGROUND

  • 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.

    PMID: 11454114BACKGROUND

  • 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.

    PMID: 10701716BACKGROUND

  • Sieminski DJ, Gardner AW. The relationship between free-living daily physical activity and the severity of peripheral arterial occlusive disease. Vasc Med. 1997 Nov;2(4):286-91. doi: 10.1177/1358863X9700200402.

    PMID: 9575600BACKGROUND

  • Sieminski DJ, Cowell LL, Montgomery PS, Pillai SB, Gardner AW. Physical activity monitoring in patients with peripheral arterial occlusive disease. J Cardiopulm Rehabil. 1997 Jan-Feb;17(1):43-7. doi: 10.1097/00008483-199701000-00006.

    PMID: 9041070BACKGROUND

  • Moreland JD, Thomson MA, Fuoco AR. Electromyographic biofeedback to improve lower extremity function after stroke: a meta-analysis. Arch Phys Med Rehabil. 1998 Feb;79(2):134-40. doi: 10.1016/s0003-9993(98)90289-1.

    PMID: 9473993BACKGROUND

  • Weatherall M. Biofeedback or pelvic floor muscle exercises for female genuine stress incontinence: a meta-analysis of trials identified in a systematic review. BJU Int. 1999 Jun;83(9):1015-6. doi: 10.1046/j.1464-410x.1999.00091.x.

    PMID: 10368247BACKGROUND

  • Beddy P, Neary P, Eguare EI, McCollum R, Crosbie J, Conlon KC, Keane FB. Electromyographic biofeedback can improve subjective and objective measures of fecal incontinence in the short term. J Gastrointest Surg. 2004 Jan;8(1):64-72; discussion 71-2. doi: 10.1016/j.gassur.2003.10.005.

    PMID: 14746837BACKGROUND

  • Dolan P, Gudex C, Kind P, Williams A. A social tariff for EuroQol: results from a UK general population survey. York Centre for Health Economics Discussion Paper 1381990 University of York, 1995

    BACKGROUND

  • Nielsen SL, Larsen B, Prahl M, Jensen CT, Jensen BE, Wenkens V. [Hospital training compared with home training in patients with intermittent claudication]. Ugeskr Laeger. 1977 Nov 14;139(46):2733-6. No abstract available. Danish.

    PMID: 595156BACKGROUND

  • Nielsen SL, Gyntelberg F, Larsen B, Lassen NA. Hospital versus home training, a clinical trial. Aktuelle probleme in der angiology 1975;30:121-126

    BACKGROUND

  • Ambrosetti M, Salerno M, Boni S, Daniele G, Tramarin R, Pedretti RF. Economic evaluation of a short-course intensive rehabilitation program in patients with intermittent claudication. Int Angiol. 2004 Jun;23(2):108-13.

    PMID: 15507886BACKGROUND

  • de Vries SO, Visser K, de Vries JA, Wong JB, Donaldson MC, Hunink MG. Intermittent claudication: cost-effectiveness of revascularization versus exercise therapy. Radiology. 2002 Jan;222(1):25-36. doi: 10.1148/radiol.2221001743.

    PMID: 11756701BACKGROUND

  • Treesak C, Kasemsup V, Treat-Jacobson D, Nyman JA, Hirsch AT. Cost-effectiveness of exercise training to improve claudication symptoms in patients with peripheral arterial disease. Vasc Med. 2004 Nov;9(4):279-85. doi: 10.1191/1358863x04vm570oa.

    PMID: 15678620BACKGROUND

  • Gommans LN, Scheltinga MR, van Sambeek MR, Maas AH, Bendermacher BL, Teijink JA. Gender differences following supervised exercise therapy in patients with intermittent claudication. J Vasc Surg. 2015 Sep;62(3):681-8. doi: 10.1016/j.jvs.2015.03.076.

    PMID: 26304482DERIVED

  • Nicolai SP, Hendriks EJ, Prins MH, Teijink JA; EXITPAD study group. Optimizing supervised exercise therapy for patients with intermittent claudication. J Vasc Surg. 2010 Nov;52(5):1226-33. doi: 10.1016/j.jvs.2010.06.106. Epub 2010 Aug 8.

    PMID: 20692797DERIVED

MeSH Terms

Conditions

Intermittent Claudication

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseasePeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Joep A.W. Teijink, PhD MD

    Atrium Medical Centre Parkstad

    PRINCIPAL INVESTIGATOR

  • Martin H. Prins, Prof. PhD MD

    Maastricht University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 20, 2006

Study Start

December 1, 2005

Study Completion

May 1, 2009

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

NL(1)