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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Behavioral: Supervised Exercise Therapy


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised exercise therapy<br>Adequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy. | Behavioral: Supervised Exercise Therapy<br> <br> |
| No Intervention: Walking advice<br>Standard care and a oral walking advice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility | Pain free walking distance WIQ ALDS | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | RAND SF 36 | 2 years | 
| Mortality |  | 2 years |