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Completed

NCT Number: NCT00497445

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atrium Medical Center

Heerlen, PO Box 4446, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

angioplasty / surgery

Procedure

Percutaneous vascular intervention or surgery for peripheral arterial disease

Angioplasty / surgery and exercise therapy

Procedure

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

Primary outcomes

  1. maximum walking distance

    Time frame: one year

Secondary outcomes

  1. quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality.

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Atrium Medical Center

Other

Registry information

Official study title

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

Acronym: NETP-extra

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jul 6, 2007
Registry last updated
Nov 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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