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Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02110251
Acronym
PEARL
Enrollment
14
Registered
2014-04-10
Start date
2011-09-30
Completion date
2014-08-31
Last updated
2019-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization

Brief 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 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.

Interventions

Sponsors

Catharina Ziekenhuis Eindhoven
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Mobility2 yearsPain free walking distance WIQ ALDS

Secondary

MeasureTime frameDescription
Quality of life2 yearsRAND SF 36
Mortality2 years

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026