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

NCT02110251 — Not applicable, Terminated, 14 participants, Catharina Ziekenhuis Eindhoven

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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

RegistryNCT02110251, acronym PEARL
StatusTerminated - Difficulties with including patients
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment14 (Actual)
SponsorCatharina Ziekenhuis Eindhoven (Other)
ConditionsPeripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
InterventionsSupervised Exercise Therapy (Behavioral)
Datesstart 2011-09-01, primary completion 2014-08-01, completion 2014-08-01, first posted 2014-04-10, last updated 2019-07-25
Locations2 sites in Netherlands

Related Papers Related Patents Related Grants Related Experts
All trials for Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization All trials of Supervised Exercise Therapy

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Supervised exercise therapyExperimentalBehavioral: Supervised Exercise TherapyAdequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy.
Walking adviceNo interventionStandard care and a oral walking advice.
  • Supervised Exercise Therapy (Behavioral)

+Outcome measures

Primary outcomes

  • Mobility [2 years]: Pain free walking distance WIQ ALDS

Secondary outcomes

  • Quality of life [2 years]: RAND SF 36
  • Mortality [2 years]

+Eligibility

Sex: All

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.

+Locations (2)

FacilityCityCountryStatus
Catharina ZiekenhuisEindhoven, North BrabantNetherlands
Medisch Centrum AlkmaarAlkmaarNetherlands

+Investigators