Clinical trial NCT00279994: (Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intermittent Claudication
Keywords: Intermittent claudication
Exercise therapy
Therapy feedback
Accelerometer
Physiotherapy
PAD;
peripheral arterial disease according to Fontaine stage II)
Lead sponsor: Atrium Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Maastricht University
First posted: 2006-01-20
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: maximal walking distance
Secondary outcomes:
measure: pain-free walking distance
measure: blood pressure
measure: fasting glucose
measure: fasting cholesterol
measure: lipids profile
measure: body weight
measure: co-morbidity
measure: vascular interventions
measure: mortality
measure: medical and non-medical costs
measure: compliance
measure: quality of life
measure: impairment
measure: complaints
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Medical Centre
state: P.O.box 4446
Study officials:
affiliation: Atrium Medical Centre Parkstad
name: Joep A.W. Teijink, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Martin H. Prins, Prof. PhD MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Gardner AW, Poehlman ET. Exercise rehabilitation programs for the treatment of claudication pain. A meta-analysis. JAMA. 1995 Sep 27;274(12):975-80.
citation: Leng GC, Fowler B, Ernst E. Exercise for intermittent claudication. Cochrane Database Syst Rev. 2000;(2):CD000990. doi: 10.1002/14651858.CD000990.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: Nielsen SL, Gyntelberg F, Larsen B, Lassen NA. Hospital versus home training, a clinical trial. Aktuelle probleme in der angiology 1975;30:121-126
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.