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NCT00279994

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

Last Updated: 2008-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-05-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Intermittent Claudication

Keywords

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Intermittent claudication Exercise therapy Therapy feedback Accelerometer Physiotherapy PAD; peripheral arterial disease according to Fontaine stage II)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Exercise therapy

Intervention Type PROCEDURE

Accelerometer (PAM; Personal Activity Monitor)

Intervention Type DEVICE

Oral Exercise Therapy advise

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Joep A.W. Teijink, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Medical Centre Parkstad

Martin H. Prins, Prof. PhD MD

Role: STUDY_CHAIR

Maastricht University

Locations

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Atrium Medical Centre

Heerlen, P.O.box 4446, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND

PMID: 12477945 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9052565 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11409225 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9112877 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14652832 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12402991 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9520973 (View on PubMed)

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

Reference Type BACKGROUND

PMID: 7674529 (View on PubMed)

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

Reference Type BACKGROUND

PMID: 10796572 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15006125 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10777239 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11282794 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15121113 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11454114 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10701716 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9575600 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9041070 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9473993 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10368247 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 14746837 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND

PMID: 595156 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND

PMID: 15507886 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 11756701 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15678620 (View on PubMed)

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.

Reference Type DERIVED

PMID: 26304482 (View on PubMed)

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.

Reference Type DERIVED

PMID: 20692797 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

945-06-252

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

Exercise therapy

Accelerometer (PAM; Personal Activity Monitor)

Oral Exercise Therapy advise

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

Maastricht University

Atrium Medical Center

Principal Investigators

Joep A.W. Teijink, PhD MD

Martin H. Prins, Prof. PhD MD

Locations

Atrium Medical Centre

Countries

References

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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.

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.

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.

Other Identifiers

945-06-252