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

Primary Purpose

Peripheral Arterial Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
angioplasty / surgery
Angioplasty / surgery and exercise therapy
Sponsored by
Atrium Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, Exercise therapy, Angioplasty, Bypass surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atrium Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Angioplasty / surgery and exercise therapy

Angioplasty / surgery

Arm Description

Angioplasty / surgery followed by supervised exercise therapy

Angioplasty / surgery alone

Outcomes

Primary Outcome Measures

maximum walking distance

Secondary Outcome Measures

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

Full Information

First Posted
July 5, 2007
Last Updated
November 5, 2009
Sponsor
Atrium Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00497445
Brief Title
The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease
Acronym
NETP-extra
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Atrium Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
Keywords
Peripheral arterial disease, Exercise therapy, Angioplasty, Bypass surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angioplasty / surgery and exercise therapy
Arm Type
Experimental
Arm Description
Angioplasty / surgery followed by supervised exercise therapy
Arm Title
Angioplasty / surgery
Arm Type
No Intervention
Arm Description
Angioplasty / surgery alone
Intervention Type
Procedure
Intervention Name(s)
angioplasty / surgery
Intervention Description
Percutaneous vascular intervention or surgery for peripheral arterial disease
Intervention Type
Procedure
Intervention Name(s)
Angioplasty / surgery and exercise therapy
Intervention Description
Percutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy
Primary Outcome Measure Information:
Title
maximum walking distance
Time Frame
one year
Secondary Outcome Measure Information:
Title
quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality.
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joep A. Teijink, PhD, MD
Organizational Affiliation
Atrium medical center Parkstad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atrium Medical Center
City
Heerlen
State/Province
PO box 4446
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21571547
Citation
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.
Results Reference
derived

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

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