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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Procedure: angioplasty / surgery
* Procedure: Angioplasty / surgery and exercise therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Angioplasty / surgery and exercise therapy<br>Angioplasty / surgery followed by supervised exercise therapy | Procedure: Angioplasty / surgery and exercise therapy<br>* Percutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy<br>|
| No Intervention: Angioplasty / surgery<br>Angioplasty / surgery alone | Procedure: angioplasty / surgery<br>* Percutaneous vascular intervention or surgery for peripheral arterial disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum walking distance |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality. |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral arterial disease, Exercise therapy, Angioplasty, Bypass surgery