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

Catharina Hospital

Status: Terminated

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

Treatments: Behavioral: Supervised Exercise Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02110251

PEARL study

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Supervised exercise therapy

Experimental group

Description:

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

Treatment:

Behavioral: Supervised Exercise Therapy

Walking advice

No Intervention group

Description:

Standard care and a oral walking advice.