Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:50 PM
Study NCT ID:
NCT00279994
Status:
UNKNOWN
Last Update Posted:
2008-05-09
First Post:
2006-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease
Sponsor:
Atrium Medical Center
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXITPAD
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: