Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-30 @ 8:59 AM
Study NCT ID:
NCT02110251
Status:
TERMINATED
Last Update Posted:
2019-07-25
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise Therapy With Risk Factor Management and Life Style Coaching After Vascular Intervention for Patients With Peripheral Arterial Disease
Sponsor:
Catharina Ziekenhuis Eindhoven
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties with including patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEARL
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: