Peripheral Arterial DiseaseNETP-extraNCT00497445
The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease
A study testing angioplasty / surgery and Angioplasty / surgery and exercise therapy in people with Peripheral Arterial Disease, run by Atrium Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- angioplasty / surgery and Angioplasty / surgery and exercise therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2005to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PAD stage 2 or 3 according to Fontaine,
- Surgical or radiological intervention indicated
Who cannot join
- No insurance for physiotherapy,
- Insufficient command of the Dutch language,
- Serious cardiopulmonary limitations (NYHA 3-4,)
- Major amputation,
- Serious co-morbidity prohibiting physical training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Exercise Therapy in Patients With Peripheral Arterial Disease: The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease.
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.
Read the 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
- Being tested
- angioplasty / surgery, Angioplasty / surgery and exercise therapy
- Keywords
- Peripheral arterial disease, Exercise therapy, Angioplasty, Bypass surgery
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplasty / surgeryProcedure or surgery
Percutaneous vascular intervention or surgery for peripheral arterial disease
Angioplasty / surgery and exercise therapyProcedure or surgery
Percutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Angioplasty / surgery and exercise therapy | Experimental | Angioplasty / surgery followed by supervised exercise therapy Receives: Procedure: Angioplasty / surgery and exercise therapy |
| Angioplasty / surgery | No intervention | Angioplasty / surgery alone Receives: Procedure: angioplasty / surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum walking distance
Measured: one year
Secondary outcomes (1)
quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startDec 2005
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atrium Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Joep A. Teijink, PhD, MD, Principal investigator, Atrium medical center Parkstad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497445
- Sponsor's protocol ID
- 06-P-62
- Acronym
- NETP-extra
- Status last verified
- Nov 2009
- First submitted
- 5 Jul 2007
- Last updated
- 6 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21571547
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Exercise Therapy in Patients With Peripheral Arterial Disease: The Value of Supervised Exercise Therapy After Invasive Treatment of Peripheral Arterial Disease.
- ClinicalTrials.gov ID
- NCT00497445
- Acronym / sponsor ID
- NETP-extra / 06-P-62
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral arterial disease, Exercise therapy, Angioplasty, Bypass surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Atrium Medical CenterUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 6 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Angioplasty / surgery and exercise therapy | Experimental | Procedure: Angioplasty / surgery and exercise therapyAngioplasty / surgery followed by supervised exercise therapy |
| Angioplasty / surgery | No intervention | Procedure: angioplasty / surgeryAngioplasty / surgery alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- PAD stage 2 or 3 according to Fontaine,
- Surgical or radiological intervention indicated
Key exclusion criteria (5 listed)
- No insurance for physiotherapy,
- Insufficient command of the Dutch language,
- Serious cardiopulmonary limitations (NYHA 3-4,)
- Major amputation,
- Serious co-morbidity prohibiting physical training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| angioplasty / surgeryPercutaneous vascular intervention or surgery for peripheral arterial disease | Procedure or surgery | Angioplasty / surgery |
| Angioplasty / surgery and exercise therapyPercutaneous vascular intervention or surgery for peripheral arterial disease followed by supervised exercise therapy | Procedure or surgery | Angioplasty / surgery and exercise therapy |
Primary outcome
maximum walking distance
Time frame: one year
1 secondary outcome
quality of life fontaine stage ankle brachial index vascular risk factors re-interventions patency mortality.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2009.
- Derived from this study: PubMed 21571547Kruidenier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joep A. Teijink, PhD, MD principal investigator
Atrium medical center Parkstad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing angioplasty / surgery and Angioplasty / surgery and exercise therapy in people with Peripheral Arterial Disease, run by Atrium Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum walking distance (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00497445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2009.