This trial is active, not recruiting.

Condition intermittent claudication
Treatments exercise therapy, accelerometer (pam; personal activity monitor), oral exercise therapy advise
Sponsor Atrium Medical Center
Collaborator ZonMw: The Netherlands Organisation for Health Research and Development
Start date December 2005
End date May 2009
Trial size 300 participants
Trial identifier NCT00279994, 945-06-252


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment

Primary Outcomes

maximal walking distance
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Secondary Outcomes

pain-free walking distance
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blood pressure
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fasting glucose
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fasting cholesterol
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lipids profile
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body weight
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vascular interventions
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medical and non-medical costs
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quality of life
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Eligibility Criteria

Male or female participants of any age.

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

Additional Information

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
Principal investigator Joep A.W. Teijink, PhD MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Atrium Medical Center.