NCT00497445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 6, 2009

Status Verified

November 1, 2009

Enrollment Period

3.8 years

First QC Date

July 5, 2007

Last Update Submit

November 5, 2009

Conditions

Peripheral Arterial Disease

Keywords

Peripheral arterial diseaseExercise therapyAngioplastyBypass surgery

Outcome Measures

Primary Outcomes (1)

  • maximum walking distance

    one year

Secondary Outcomes (1)

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

    one year

Study Arms (2)

Angioplasty / surgery and exercise therapy

EXPERIMENTAL

Angioplasty / surgery followed by supervised exercise therapy

Procedure: Angioplasty / surgery and exercise therapy

Angioplasty / surgery

NO INTERVENTION

Angioplasty / surgery alone

Procedure: angioplasty / surgery

Interventions

angioplasty / surgeryPROCEDURE

Percutaneous vascular intervention or surgery for peripheral arterial disease

Angioplasty / surgery
Angioplasty / surgery and exercise therapyPROCEDURE

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

Angioplasty / surgery and exercise therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • PAD stage 2 or 3 according to Fontaine,
  • Surgical or radiological intervention indicated

You may not qualify if:

  • No insurance for physiotherapy,
  • Insufficient command of the Dutch language,
  • Serious cardiopulmonary limitations (NYHA 3-4,)
  • Major amputation,
  • Serious co-morbidity prohibiting physical training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Medical Center

Heerlen, PO Box 4446, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 21571547DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

AngioplastySurgical Procedures, OperativeExercise Therapy

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresMinimally Invasive Surgical ProceduresInvestigative TechniquesRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Therapy Modalities

Study Officials

  • Joep A. Teijink, PhD, MD

    Atrium medical center Parkstad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 6, 2007

Study Start

December 1, 2005

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 6, 2009

Record last verified: 2009-11

Locations

NL(1)