(Cost) Effectiveness Study of Exercise Therapy in Patients With Peripheral Arterial Disease (EXITPAD)

May 6, 2008 updated by: Atrium Medical Center

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • P.O.box 4446
      • Heerlen, P.O.box 4446, Netherlands, 6401 CX
        • Atrium Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
maximal walking distance

Secondary Outcome Measures

Outcome Measure
quality of life
mortality
blood pressure
fasting glucose
body weight
pain-free walking distance
compliance
fasting cholesterol
lipids profile
co-morbidity
vascular interventions
medical and non-medical costs
impairment
complaints

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atrium Medical Center

Collaborators

Maastricht University
ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Joep A.W. Teijink, PhD MD, Atrium Medical Centre Parkstad
  • Study Chair: Martin H. Prins, Prof. PhD MD, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

January 19, 2006

First Submitted That Met QC Criteria

January 19, 2006

First Posted (Estimate)

January 20, 2006

Study Record Updates

Last Update Posted (Estimate)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 6, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 945-06-252

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intermittent Claudication

Clinical Trials on Exercise therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe