Clinical Trials Directory

Trials / Completed

CompletedNCT00497445

The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease

Additional Exercise Therapy in Patients With Peripheral Arterial Disease: The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease.

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
86 (actual)
Sponsor
Atrium Medical Center · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREangioplasty / surgeryPercutaneous vascular intervention or surgery for peripheral arterial disease
PROCEDUREAngioplasty / surgery and exercise therapyPercutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy

Timeline

Start date
2005-12-01
Primary completion
2009-09-01
Completion
2009-09-01
First posted
2007-07-06
Last updated
2009-11-06

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT00497445. Inclusion in this directory is not an endorsement.