The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease (NETP-extra)
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|ClinicalTrials.gov Identifier: NCT00497445|
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : November 6, 2009
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Procedure: angioplasty / surgery Procedure: Angioplasty / surgery and exercise therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2005|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Experimental: Angioplasty / surgery and exercise therapy
Angioplasty / surgery followed by supervised exercise therapy
Procedure: Angioplasty / surgery and exercise therapy
Percutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy
No Intervention: Angioplasty / surgery
Angioplasty / surgery alone
Procedure: angioplasty / surgery
Percutaneous vascular intervention or surgery for peripheral arterial disease
- maximum walking distance [ Time Frame: one year ]
- quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality. [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00497445
|Atrium Medical Center|
|Heerlen, PO box 4446, Netherlands|
|Principal Investigator:||Joep A. Teijink, PhD, MD||Atrium medical center Parkstad|