Peripheral Arterial Disease Clinical Trial
Official title:
Additional Exercise Therapy in Patients With Peripheral Arterial Disease: The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease.
The objective of this study is to investigate what the value is of SET after a radiological or surgical intervention for peripheral arterial disease in the aorto-iliacal, femoro-popliteal and crural segments in comparison with a control group.
Treatment of peripheral arterial disease consists of vascular risk factor management and,
dependent on the severity of the disease, exercise therapy, and either radiological or
surgical intervention. After invasive treatment, many patients keep complaints, or
complaints return, despite the fact that the treated segment is still patent.
Supervised exercise therapy (SET) has been proved to be an effective treatment for patients
with intermittent claudication, with a significant increase in maximal walking distance.
Further, exercise therapy contributes to an improvement in quality of life, a delay in
disease progression and an improvement of the vascular risk profile.
Research on SET after an invasive intervention is rare. In one study, the effect of SET
after surgical treatment on walking distance was determined. The initial claudication
distance increased significantly in the exercise group, compared with surgical treatment
alone.
In June 2004, the Network for Exercise Therapy Parkstad (NETP) was implemented in Heerlen
and its environs. The physiotherapists of this network provide community based SET according
to the protocol of the Royal Dutch Society of Physiotherapy. The web based database, which
is a part of the NETP, was retrospectively searched for patients who started SET within 2
months after a radiological or surgical intervention. Seventeen patients fulfilled these
criteria, and after 1, 3, 6 and 12 months, there was a significant increase in both initial
claudication distance (ICD) and absolute claudication distance (ACD).
The expectation is that SET, immediately offered after an invasive intervention for
peripheral arterial disease, influences walking distance and quality of life. Further, a
positive influence on vascular risk factors and the frequency of re-interventions is
expected.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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