Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease (PEARL)
Primary Purpose
Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Supervised Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
Eligibility Criteria
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.
Sites / Locations
- Catharina Ziekenhuis
- Medisch Centrum Alkmaar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Supervised exercise therapy
Walking advice
Arm Description
Adequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy.
Standard care and a oral walking advice.
Outcomes
Primary Outcome Measures
Mobility
Pain free walking distance WIQ ALDS
Secondary Outcome Measures
Quality of life
RAND SF 36
Mortality
Full Information
NCT ID
NCT02110251
First Posted
April 1, 2014
Last Updated
July 23, 2019
Sponsor
Catharina Ziekenhuis Eindhoven
1. Study Identification
Unique Protocol Identification Number
NCT02110251
Brief Title
Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease
Acronym
PEARL
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulties with including patients
Study Start Date
September 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catharina Ziekenhuis Eindhoven
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Rutherford 4 and 5 With Possibility to Improve Vascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supervised exercise therapy
Arm Type
Experimental
Arm Description
Adequacy of initial therapy, Investigation degree of confusion and dementia, Preoperative preparation, Life-style coaching, Supervised Exercise therapy.
Arm Title
Walking advice
Arm Type
No Intervention
Arm Description
Standard care and a oral walking advice.
Intervention Type
Behavioral
Intervention Name(s)
Supervised Exercise Therapy
Primary Outcome Measure Information:
Title
Mobility
Description
Pain free walking distance WIQ ALDS
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of life
Description
RAND SF 36
Time Frame
2 years
Title
Mortality
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joep Teijink, prof. dr.
Organizational Affiliation
Catharina Ziekenhuis Eindhoven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catharina Ziekenhuis
City
Eindhoven
State/Province
Noord-Brabant
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Medisch Centrum Alkmaar
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease
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