Status:
UNKNOWN
(Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease
Lead Sponsor:
Atrium Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University
Conditions:
Intermittent Claudication
Eligibility:
All Genders
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- PAD stage II
- Ankle-brachial index below 0.9
- Maximal walking distance of 500 meters or less
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00279994
Start Date
December 1 2005
End Date
May 1 2009
Last Update
May 9 2008
Active Locations (1)
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1
Atrium Medical Centre
Heerlen, P.O.box 4446, Netherlands, 6401 CX