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

NCT02110251 | Terminated

• 1 other identifier: PEARL study
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Mobility

  Pain free walking distance WIQ ALDS

  2 years

Secondary Outcomes (2)

• Quality of life

  2 years

• Mortality

  2 years

Study Arms (2)

Supervised exercise therapy

EXPERIMENTAL

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

Behavioral: Supervised Exercise Therapy

Walking advice

NO INTERVENTION

Standard care and a oral walking advice.

Interventions

Supervised Exercise Therapy BEHAVIORAL

Supervised exercise therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead

Study Sites (2)

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Joep Teijink, prof. dr.

  Catharina Ziekenhuis Eindhoven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 10, 2014
• Study Start: September 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 25, 2019

Record last verified: 2019-07

Locations

NL (2)