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

Not Applicable

Terminated

• Conditions: Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
• Interventions: Behavioral: Supervised Exercise Therapy

• Registration Number: NCT02110251
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-10
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised exercise therapy	Supervised Exercise Therapy	Adequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy.

Primary Outcome Measures

Name	Time	Method
Mobility	2 years	Pain free walking distance WIQ ALDS

Secondary Outcome Measures

Name	Time	Method
Mortality	2 years
Quality of life	2 years	RAND SF 36

Trial Locations

Locations (2)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Medisch Centrum Alkmaar; 🇳🇱 Alkmaar, Netherlands