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

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

— PEARL  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02110251
• Other study ID #: PEARL study
• Status: Terminated
• Phase: N/A
• Start date: September 2011
• Est. completion date: August 2014

Study information

• Verified date: July 2019
• Source: Catharina Ziekenhuis Eindhoven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Neovascularization, Pathologic
• Peripheral Arterial Disease
• Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
• Peripheral Vascular Diseases

Intervention

Behavioral:
• Supervised Exercise Therapy

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Alkmaar	Alkmaar
Netherlands	Catharina Ziekenhuis	Eindhoven	Noord-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility	Pain free walking distance WIQ ALDS	2 years
Secondary	Quality of life	RAND SF 36	2 years
Secondary	Mortality		2 years