(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
  Purpose

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 Intervention
Intermittent Claudication
Procedure: Exercise therapy
Device: Accelerometer (PAM; Personal Activity Monitor)
Procedure: Oral Exercise Therapy advise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Atrium Medical Center:

Primary Outcome Measures:
  • maximal walking distance

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 300
Study Start Date: December 2005
Estimated Study Completion Date: May 2009
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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Additional 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
Study First Received: January 19, 2006
Last Updated: May 6, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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:
Intermittent Claudication
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Atherosclerosis

ClinicalTrials.gov processed this record on April 16, 2014