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

Intermittent Claudication Clinical Trial

— EXITPAD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00279994
• Other study ID #: 945-06-252
• Status: Active, not recruiting
• Phase: N/A
• First received: January 19, 2006
• Last updated: May 6, 2008
• Start date: December 2005
• Est. completion date: May 2009

Study information

• Verified date: May 2008
• Source: Atrium Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Procedure:
• Exercise therapy

Device:
• Accelerometer (PAM; Personal Activity Monitor)

Procedure:
• Oral Exercise Therapy advise

Locations

Country	Name	City	State
Netherlands	Atrium Medical Centre	Heerlen	P.O.box 4446

Sponsors (3)

Lead Sponsor	Collaborator
Atrium Medical Center	Maastricht University, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (26)

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. — View 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. — View 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. — View 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. Erratum in: Phys Ther 1998 May;78(5):547. — View 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. — View 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. — View 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. — View 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

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. Review. — View 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. — View 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. — View 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. — View Citation

Leng GC, Fowler B, Ernst E. Exercise for intermittent claudication. Cochrane Database Syst Rev. 2000;(2):CD000990. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD000990. — View 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. — View 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. — View 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

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. Danish. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Stewart KJ, Hiatt WR, Regensteiner JG, Hirsch AT. Exercise training for claudication. N Engl J Med. 2002 Dec 12;347(24):1941-51. Review. — View 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. — View 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. — View Citation

Willigendael EM, Teijink JA, Bartelink ML, Boiten J, Moll FL, Büller HR, Prins MH. Peripheral arterial disease: public and patient awareness in The Netherlands. Eur J Vasc Endovasc Surg. 2004 Jun;27(6):622-8. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal walking distance
Secondary	pain-free walking distance
Secondary	blood pressure
Secondary	fasting glucose
Secondary	fasting cholesterol
Secondary	lipids profile
Secondary	body weight
Secondary	co-morbidity
Secondary	vascular interventions
Secondary	mortality
Secondary	medical and non-medical costs
Secondary	compliance
Secondary	quality of life
Secondary	impairment
Secondary	complaints