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The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease (NETP-extra)

This study has been completed.
Sponsor:
Information provided by:
Atrium Medical Center
ClinicalTrials.gov Identifier:
NCT00497445
First received: July 5, 2007
Last updated: November 5, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
 Procedure: angioplasty / surgery
Procedure: Angioplasty / surgery and exercise therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Additional Exercise Therapy in Patients With Peripheral Arterial Disease: The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Atrium Medical Center:

Primary Outcome Measures:
  • maximum walking distance [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality. [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: December 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497445

Locations
Netherlands
Atrium Medical Center
Heerlen, PO box 4446, Netherlands
Sponsors and Collaborators
Atrium Medical Center
Investigators
Principal Investigator: Joep A. Teijink, PhD, MD Atrium medical center Parkstad
  More Information

No publications provided by Atrium Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. JAW Teijink, Atrium medical centre
ClinicalTrials.gov Identifier: NCT00497445     History of Changes
Other Study ID Numbers: 06-P-62
Study First Received: July 5, 2007
Last Updated: November 5, 2009
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Atrium Medical Center:
Peripheral arterial disease
Exercise therapy
Angioplasty
Bypass surgery

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013