Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve VascularizationPEARLNCT02110251
Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease
A study testing Supervised Exercise Therapy in people with Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization, run by Catharina Ziekenhuis Eindhoven at 2 sites in Netherlands.
Trial summary
Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate. So far, treatment strategies focused on the preservation of life and limb by an open surgical or endovascular revascularization, together with cardiovascular risk… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
- What is being tested?
- Supervised Exercise Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2011to Aug 2014
- 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
- Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention.
- Patients with both legs are affected, but the most severe leg does not exceed stage 5.
Who cannot join
- Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh.
- Patients with limited amputation of the toes can participate.
- Insufficient understanding of the Dutch language.
- No physiotherapy insurance.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medisch Centrum Alkmaar
Alkmaar, 1815 JD
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ
About this study
Official title: Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease With Critical Limb Ischemia or Tissue Loss. A Pilot Study
Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate. So far, treatment strategies focused on the preservation of life and limb by an open surgical or endovascular revascularization, together with cardiovascular risk management and pain relief. Important modifiable factors related to mortality and morbidity are not covered in the current national and international guidelines. This study investigates the effects on mobility, mortality and quality of life with supplementation of the standard treatment of critical limb ischemia with supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor management and lifestyle coaching will be taken in to account. The supervised exercise therapy will take place under the supervision of a trained physiotherapist.
- Conditions
- Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
- Being tested
- Supervised Exercise Therapy
- 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.
Supervised Exercise TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise therapy | Experimental | Adequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy. Receives: Behavioral: Supervised Exercise Therapy |
| Walking advice | No intervention | Standard care and a oral walking advice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility
Pain free walking distance WIQ ALDS
Measured: 2 years
Secondary outcomes (2)
Quality of life
RAND SF 36
Measured: 2 years
Mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startSep 2011
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Difficulties with including patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve VascularizationStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joep Teijink, Catharina Ziekenhuis Eindhoven
- Investigators
- Joep Teijink, prof. dr., Principal investigator, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110251
- Sponsor's protocol ID
- PEARL study
- Acronym
- PEARL
- Status last verified
- Jul 2019
- First submitted
- 1 Apr 2014
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease With Critical Limb Ischemia or Tissue Loss. A Pilot Study
- ClinicalTrials.gov ID
- NCT02110251
- Acronym / sponsor ID
- PEARL / PEARL study
- Conditions
- Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with including patients
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Apr 2014 (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.
Patients with peripheral arterial disease with symptoms of critical ischemia or reduced tissue loss have a very high mortality and morbidity rate. So far, treatment strategies focused on the preservation of life and limb by an open surgical or endovascular revascularization, together with cardiovascular risk management and pain relief. Important modifiable factors related to mortality and morbidity are not covered in the current national and international guidelines. This study investigates the effects on mobility, mortality and quality of life with supplementation of the standard treatment of critical limb ischemia with supervised exercise therapy. Also a reduction of cardiovascular risk by intensive risk factor management and lifestyle coaching will be taken in to account. The supervised exercise therapy will take place under the supervision of a trained physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise therapy | Experimental | Behavioral: Supervised Exercise TherapyAdequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy. |
| Walking advice | No intervention | –Standard care and a oral walking advice. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention.
- Patients with both legs are affected, but the most severe leg does not exceed stage 5.
Key exclusion criteria (4 listed)
- Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh.
- Patients with limited amputation of the toes can participate.
- Insufficient understanding of the Dutch language.
- No physiotherapy insurance.
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 |
|---|---|---|
| Supervised Exercise Therapy | Behavioural | Supervised exercise therapy |
Primary outcome
Mobility
Time frame: 2 years
Pain free walking distance WIQ ALDS
2 secondary outcomes
Quality of life
Time frame: 2 years
Mortality
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Difficulties with including patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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Peripheral Arterial Disease Below the Knee, Peripheral Arterial Disease, Rutherford 4 and 5 with Possibility to Improve Vascularization
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 Teijink, prof. dr. principal investigator
Catharina Ziekenhuis Eindhoven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise Therapy in people with Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization, run by Catharina Ziekenhuis Eindhoven at 2 sites 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 4 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: stopped early, as of the sponsor's last update on 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Difficulties with including patients). Results are not available in the source record.
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?
Mobility (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2019.