Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

(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
Sponsor:
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

January 19, 2006
May 6, 2008
December 2005
Not Provided
maximal walking distance
maximum walking distance
Complete list of historical versions of study NCT00279994 on ClinicalTrials.gov Archive Site
  • pain-free walking distance
  • blood pressure
  • fasting glucose
  • fasting cholesterol
  • lipids profile
  • body weight
  • co-morbidity
  • vascular interventions
  • mortality
  • medical and non-medical costs
  • compliance
  • quality of life
  • impairment
  • complaints
Same as current
Not Provided
Not Provided
 
(Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease
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

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Intermittent Claudication
  • Procedure: Exercise therapy
  • Device: Accelerometer (PAM; Personal Activity Monitor)
  • Procedure: Oral Exercise Therapy advise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
May 2009
Not Provided

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00279994
945-06-252
Not Provided
Not Provided
Atrium Medical Center
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Maastricht University
Principal Investigator: Joep A.W. Teijink, PhD MD Atrium Medical Centre Parkstad
Study Chair: Martin H. Prins, Prof. PhD MD Maastricht University
Atrium Medical Center
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP