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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-08-31

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supervised exercise therapy

Adequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy.

Group Type EXPERIMENTAL

Supervised Exercise Therapy

Intervention Type BEHAVIORAL

Walking advice

Standard care and a oral walking advice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Supervised Exercise Therapy

Intervention Type BEHAVIORAL

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No