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Intermittent Claudication clinical trials

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NCT ID: NCT02927574 Completed - Clinical trials for Peripheral Arterial Disease

Systematic Review and Meta-Analysis on DCB vs. POBA in De-novo Femoropopliteal Disease

DOND
Start date: July 2016
Phase:
Study type: Observational [Patient Registry]

Restenosis is still an issue after endovascular revascularization for femoropopliteal occlusive disease. One approach to reduce the rates of restenosis and reintervention is local application of Paclitaxel with drug-coated balloon angioplasty. The purpose is to conduct a systematic review and meta-analysis of randomized-controlled trials comparing on Drug-Coated Balloon angioplasty (DCB) vs. Plain Old Balloon Angioplasty (POBA) in de-novo femoropopliteal disease.

NCT ID: NCT02897947 Completed - Spinal Stenosis Clinical Trials

Outcome of Surgery for Lumbar Spinal Stenosis - a Comparison of Data From Three National Quality Registries

Start date: January 2011
Phase:
Study type: Observational [Patient Registry]

There is no international consensus on evaluation and surgical treatment of Lumbar Spinal Stenosis (LSS). The indication for operative treatment is relative, and the variation in surgical rates and procedures is significant, both within and between countries. Understanding practice-based variety is critical since these differences may reflect a disparity in quality of the health care in different institutions, regions, or countries. Norway, Sweden, and Denmark do all have National spine registers for research and quality assessment. Comparing indications for surgery, selected procedure, patient reported outcomes, and factors predicting outcome after surgery for LSS between these countries could provide information about optimal indications and strategy for surgery. Register-based studies have advantages such as large sample sizes and high external validity, but also limitations such as lower follow-up rates, and inferior data quality compared to clinical trials. Hypotheses: Between these three countries, there are no differences in (i) indications for surgery, (ii) patient-reported outcome after surgery or (iii) risk factors associated to outcome are similar.

NCT ID: NCT02823444 Completed - Clinical trials for Peripheral Arterial Disease

Non-Contrast Enhanced Peripheral Magnetic Resonance Angiography

Start date: April 2008
Phase:
Study type: Observational

To systematically develop, test, and refine peripheral vascular electrocardiography-gated fast spin echo magnetic resonance imaging for the accurate diagnosis of peripheral arterial disease without gadolinium contrast. To test prospectively the accuracy of fast spin echo in peripheral arterial disease patients, compared with bolus-chase and time-resolved gadolinium enhanced magnetic resonance angiography. Additionally, as a substudy of this project, we will compare our fast spin echo approach with alternative non-contrast-enhanced magnetic resonance imaging methods such as time-of-flight and steady-state gradient echo imaging. The overarching goals of our research are to develop and validate a peripheral magnetic resonance imaging technique that accurately depicts anatomy and disease without exposing patients to exogenous contrast material and its associated risks.

NCT ID: NCT02778568 Completed - Clinical trials for Peripheral Artery Disease

Acute Cardiovascular Responses and Chronic Adaptations of Strength Exercise in Intermittent Claudication Patients

Start date: January 2010
Phase: N/A
Study type: Interventional

The aim of this study was to analyze the effects of resistance exercise and training on cardiovascular function of peripheral artery disease patients.

NCT ID: NCT02770547 Completed - Clinical trials for Peripheral Artery Disease

Leg Thermotherapy for Intermittent Claudication

Start date: May 30, 2016
Phase: N/A
Study type: Interventional

This study proposes to evaluate the potential of leg thermotherapy as a non-pharmacological intervention that could improve the mobility and exercise tolerance of patients with intermittent claudication. Thermotherapy is a simple, easily applicable therapy that enhances exercise tolerance in patients with chronic heart failure by improving peripheral vascular endothelial function.

NCT ID: NCT02719665 Completed - Osteoarthritis Clinical Trials

THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease

Start date: March 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."

NCT ID: NCT02642276 Completed - Clinical trials for Peripheral Arterial Disease

Exercise Training in Individuals With Peripheral Arterial Disease

Start date: June 2015
Phase: N/A
Study type: Interventional

In this controlled trial, patients with peripheral arterial disease will be randomized to either maximal walking, submaximal walking, or usual care groups.

NCT ID: NCT02641418 Completed - Clinical trials for Intermittent Claudication

Optimising the Efficacy, Patient Perception and Uptake of an Exercise Programme in People in Intermittent Claudication

SEIC
Start date: May 2015
Phase: N/A
Study type: Interventional

Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the major arteries supplying the lower limbs and is associated with an increased risk of mortality and morbidity. It results in restricted blood flow to the skeletal muscles causing intermittent claudication (IC). IC presents as cramp like pain affecting 5% of the population >50 years and is associated with a substantial reduction in walking capacity, quality of life and diminished physical function. Supervised exercise programmes have been demonstrated to improve maximum walking distances and NICE recommends group-based supervised exercise for treating patients with IC. However, there is significant variability in the impact of treatment across studies and little agreement on the underlying mechanism whereby exercise increases functional outcomes. Potential mechanisms include skeletal muscle metabolism, VO2 max, anaerobic threshold and endothelial function. Studies are needed to better understand how exercise improves outcome and in whom, so as to better refine and target the treatment. The participation of patients with IC in exercise programmes is low. The investigators need to understand factors influencing participation so that we can improve the number of patients with IC benefiting from the programme The research consists of two workstreams: Workstream one Objective: Assess the extent to which patient baseline characteristics and candidate physiological mechanisms are associated with clinical improvement in IC patients participating in an exercise programme Patients: Patients with documented IC referred from a Vascular Consultant. Eligible patients will be invited to participate in a 12 week supervised exercise programme. Testing Schedule: Measurements will be recorded at baseline (prior to exercise), immediately after the completion of the exercise programme and then three months after. Measurements include: Baseline characteristics that might predict outcome: - Quality of life using the VascuQol questionnaire - Clinical indicators of lower limb function: Ankle brachial pressure index (ABPI), intermittent claudication distance (ICD), Maximum walking distance (MWD). Candidate physiological mechanisms - Aerobic capacity (VO2 max & AT) - Muscular strength and endurance - Muscle morphology (including muscle thickness, pennation angle, fascicle length and elastography) - Endothelial function (sheer stress response as measured by flow mediated dilation) Analysis: Regression analysis will be used to explain variation in patient maximum walking distance at 3 months. The regression will use 9 candidate measures of physiological response and 3 baseline measures to explore what mechanism and patient factors may be associated with clinical improvements. 100 patients recruited over 2 years will give a 90% power to detect an additional increase in variability in MWD explained by each candidate measure of around 5% at the a 0.05 significance level. This research will be used to identify which types of exercise may be most influential in improving outcome and in which patients. Workstream two Objective: Explore the reasons behind patients' participation, non-participation in, experience of and adherence to the exercise programme. Study Design: An interview study of patients with IC routinely referred for supervised exercise. Three groups of patients will be invited to participate. Those who: - Choose not to participate in the exercise programme (Group A) - Agree to participate in the exercise programme (Group B). - Agree to participate but discontinue after at least one session (Group C). Semi-structured face-to-face interviews with 20 patients per group, interviews will be conducted using a topic guide to ensure consistency. The format will be flexible to allow participants to generate naturalistic data on what they consider as important and / or successful in terms of outcome. Data will be analysed thematically and managed using Nvivo software - the approach will be inductive and iterative. This research will be used to redesign the current exercise programme to improve participation and so the impact of exercise in patients with IC.

NCT ID: NCT02607046 Completed - Clinical trials for Peripheral Arterial Disease

Exercise Rehabilitation in Veterans With PAD

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project will be conducted patients with PAD that require revascularization. The goal is to examine the effects of 3 months of exercise rehabilitation or neuromuscular stimulation on leg blood flow, physical function, quality of life and general health.

NCT ID: NCT02505503 Completed - Clinical trials for Peripheral Arterial Disease

York Study of Unloading Shoes for Vascular Intermittent Claudication

YORVIC
Start date: July 2015
Phase: N/A
Study type: Interventional

Some people experience a cramp-like leg pain during walking that is relieved only by rest. This is called intermittent claudication (IC) and it is a common symptom of peripheral arterial disease. Patients with IC struggle to walk, which in turn lowers their quality of life. The intensity of IC pain experienced during walking depends on several factors, including the type of footwear worn. For example, non-supportive shoes may make the calf muscles work harder during walking, leading to earlier and more-severe symptoms of IC. A member of the research team has developed a shoe that reduces the work done by the lower-leg muscles during walking. Preliminary data indicate that, when wearing these "unloading shoes", people with IC were able to walk further without pain as compared with when wearing a normal pair of shoes. The current project aims to provide further information on the usefulness and acceptability of these shoes. Forty people with IC will complete a set of three walking tests on two separate occasions; once whilst wearing the unloading shoes, and once whilst wearing some normal shoes. The participants will then be given a pair of unloading or normal shoes to wear for two weeks, after which we will collect information on how acceptable the shoes were to wear via a survey of all participants and one-to-one interviews with a subset of participants.