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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00497445
Acronym
NETP-extra
Enrollment
86
Registered
2007-07-06
Start date
2005-12-31
Completion date
2009-09-30
Last updated
2009-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial disease, Exercise therapy, Angioplasty, Bypass surgery

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.

Interventions

PROCEDUREangioplasty / surgery

Percutaneous vascular intervention or surgery for peripheral arterial disease

PROCEDUREAngioplasty / surgery and exercise therapy

Percutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy

Sponsors

Atrium Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
maximum walking distanceone year

Secondary

MeasureTime frame
quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality.one year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026