Clinical trial NCT00497445: The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease
Official title: Additional Exercise Therapy in Patients With Peripheral Arterial Disease: The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: Peripheral arterial disease
Exercise therapy
Angioplasty
Bypass surgery
Lead sponsor: Atrium Medical Center
Sponsor class: OTHER
First posted: 2007-07-06
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* PAD stage 2 or 3 according to Fontaine,
* Surgical or radiological intervention indicated

Exclusion Criteria:

* No insurance for physiotherapy,
* Insufficient command of the Dutch language,
* Serious cardiopulmonary limitations (NYHA 3-4,)
* Major amputation,
* Serious co-morbidity prohibiting physical training

Primary outcomes:
measure: maximum walking distance
timeFrame: one year
Secondary outcomes:
measure: quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality.
timeFrame: one year
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Medical Center
state: PO box 4446
Study officials:
affiliation: Atrium medical center Parkstad
name: Joep A. Teijink, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kruidenier LM, Nicolai SP, Rouwet EV, Peters RJ, Prins MH, Teijink JA. Additional supervised exercise therapy after a percutaneous vascular intervention for peripheral arterial disease: a randomized clinical trial. J Vasc Interv Radiol. 2011 Jul;22(7):961-8. doi: 10.1016/j.jvir.2011.02.017. Epub 2011 May 14.