Peripheral Arterial Disease Clinical Trial
Official title:
Supervised Physical Activity in Subjects With Symptomatic Peripheral Arterial Disease. ARTPERfit Randomized Clinical Trial.
Peripheral arterial disease is part of the diseases derived from arteriosclerosis are the
leading cause of mortality in developed countries. There is evidence of the benefits of
physical exercise programs supervised in patients with cardiovascular risk. Despite being a
treatment with proven efficacy and relatively inexpensive, it continues being little used for
the management of patients with intermittent claudication caused by peripheral arterial
disease.
The objective of this study is to develop an evidence-based intervention strategy on the
effectiveness of supervised physical exercise in intermittent claudication to determine its
impact compared to standard counselling in these patients.
Peripheral arterial disease is part of the diseases derived from arteriosclerosis, such as
myocardial infarction or stroke. These entities are the leading cause of mortality in
developed countries. The peripheral arterial disease is a narrowing of the diameter of the
arteries in the legs due to plaque formation of atheroma. When the obstruction is significant
enough, there is a decrease in blood flow to the musculature of the lower limbs and
consequently, depending on the severity of the narrowing, we can find from asymptomatic
patients to patients with atrophic lesions, going through different degrees of pain when
walking or at rest.
It is estimated that in 2010 more than 200 million people had peripheral arterial disease
worldwide, with symptoms that range from mild to severe. The forecast is heading towards an
increase in prevalence due to the increase in the life span of the world population and
cardiovascular risk factors.
There is evidence in countries with high cardiovascular risk regarding the benefit obtained
in physical exercise programs supervised in patients with pain when walking, both in
increasing the distance walked and in prolonging at the time of onset of pain. Despite being
a treatment with proven efficacy and relatively inexpensive, it continues being little used
for the management of patients with intermittent claudication caused by arteriopathy in
Spain.
This project aims to assess the effectiveness of various supervised physical exercise
programs in patients with Symptomatic Peripheral Artery Disease (Intermittent Claudication)
versus single advice to exercise without supervision. After a first initial assessment visit,
four groups will be formed at random. A control group who will be given standard advice to
perform physical exercise and three experimental intervention groups. They will be assessed
at 3 and 6 months after performing sessions of supervised exercise lasting one hour 3 times a
week and 12 months after the initial visit, (after 6 months of end supervised exercise
sessions). The impact in terms of changes in quality of life will also be evaluated.
In the longer term, and depending on the results obtained, it is intended to implement a
similar intervention, at the level of primary care, or as close as possible to the place of
residence of this type of patient to facilitate the performance of the exercise, improve the
symptoms and quality of life of these patients
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
| Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
| Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
| Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
| Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
| Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
| Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
| Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
| Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
| Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
| Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
| Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
| Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
| Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
| Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
| Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
| Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
| Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
| Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
| Completed |
NCT02022423 -
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
|
N/A |