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Clinical Trials/NCT00279994
NCT00279994
Unknown
Not Applicable

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

Atrium Medical Center1 site in 1 country300 target enrollmentDecember 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intermittent Claudication
Sponsor
Atrium Medical Center
Enrollment
300
Locations
1
Primary Endpoint
maximal walking distance
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
May 2009
Last Updated
17 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • PAD stage II
  • Ankle-brachial index below 0.9
  • Maximal walking distance of 500 meters or less

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

maximal walking distance

Secondary Outcomes

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

Study Sites (1)

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