(Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease (EXITPAD)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Atrium Medical Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Atrium Medical Center
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University
Information provided by:
Atrium Medical Center
ClinicalTrials.gov Identifier:
NCT00279994
First received: January 19, 2006
Last updated: May 6, 2008
Last verified: May 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 19, 2006 | ||||||||
| Last Updated Date | May 6, 2008 | ||||||||
| Start Date ICMJE | December 2005 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
maximal walking distance | ||||||||
| Original Primary Outcome Measures ICMJE |
maximum walking distance | ||||||||
| Change History | Complete list of historical versions of study NCT00279994 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | (Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease | ||||||||
| Official Title ICMJE | 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 | ||||||||
| 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Intermittent Claudication | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Estimated Enrollment ICMJE | 300 | ||||||||
| Estimated Completion Date | May 2009 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00279994 | ||||||||
| Other Study ID Numbers ICMJE | 945-06-252 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Atrium Medical Center | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Atrium Medical Center | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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