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

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ClinicalTrials.gov Identifier: NCT00279994
Recruitment Status : Unknown
Verified May 2008 by Atrium Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : January 20, 2006
Last Update Posted : May 9, 2008
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University
Information provided by:
Atrium Medical Center

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).

Condition or disease Intervention/treatment Phase
Intermittent Claudication Procedure: Exercise therapy Device: Accelerometer (PAM; Personal Activity Monitor) Procedure: Oral Exercise Therapy advise Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Estimated Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. maximal walking distance

Secondary Outcome Measures :
  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


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279994


Locations
Netherlands
Atrium Medical Centre
Heerlen, P.O.box 4446, Netherlands, 6401 CX
Sponsors and Collaborators
Atrium Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University
Investigators
Principal Investigator: Joep A.W. Teijink, PhD MD Atrium Medical Centre Parkstad
Study Chair: Martin H. Prins, Prof. PhD MD Maastricht University

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00279994     History of Changes
Other Study ID Numbers: 945-06-252
First Posted: January 20, 2006    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Atrium Medical Center:
Intermittent claudication
Exercise therapy
Therapy feedback
Accelerometer
Physiotherapy
PAD;
peripheral arterial disease according to Fontaine stage II)

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms