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

NCT ID: NCT00497445

Last Updated: 2009-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2009-09-30

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angioplasty / surgery and exercise therapy

Angioplasty / surgery followed by supervised exercise therapy

Group Type: EXPERIMENTAL

Angioplasty / surgery and exercise therapy

Intervention Type: PROCEDURE

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

Angioplasty / surgery

Angioplasty / surgery alone

Group Type: NO_INTERVENTION

angioplasty / surgery

Intervention Type: PROCEDURE

Percutaneous vascular intervention or surgery for peripheral arterial disease

Interventions

angioplasty / surgery

Percutaneous vascular intervention or surgery for peripheral arterial disease

Intervention Type: PROCEDURE

Angioplasty / surgery and exercise therapy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atrium Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Atrium medical centre

Principal Investigators

Joep A. Teijink, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium medical center Parkstad

Locations

Atrium Medical Center

Heerlen, PO Box 4446, Netherlands

Countries

Netherlands

References

Kruidenier LM, Nicolai SP, Rouwet EV, Peters RJ, Prins MH, Teijink JA. Additional supervised exercise therapy after a percutaneous vascular intervention for peripheral arterial disease: a randomized clinical trial. J Vasc Interv Radiol. 2011 Jul;22(7):961-8. doi: 10.1016/j.jvir.2011.02.017. Epub 2011 May 14.

Reference Type: DERIVED

PMID: 21571547 (View on PubMed)

Other Identifiers

06-P-62

Identifier Type: -

Identifier Source: org_study_id