Extracorporeal shockwave therapy for the treatment of lower limb intermittent claudication: Study protocol for a randomised controlled trial (the SHOCKWAVE 1 trial)

© 2017 The Author(s). Background: Peripheral arterial disease (PAD) has a population prevalence of 4.6% with intermittent claudication (IC) presenting as one of the earliest and most common symptoms. PAD has detrimental effects on patients' walking ability in terms of maximum walking distance (MWD) and pain-free walking distance (PFWD). Research has suggested extracorporeal shockwave therapy (ESWT) may induce angiogenesis in treated tissue; therefore, our objective is to assess the tolerability and efficacy of ESWT as a novel treatment of intermittent claudication. Methods/design: Patients with unilateral claudication will be randomised to receive either ESWT (PiezoWave 2 shockwave system) or sham treatment to the calf muscle bulk three times per week for 3 weeks. All patients are blinded to treatment group, and all assessments will be performed by a masked assessor. Treatment tolerability using a visual analogue scale, ankle-brachial pressure index, MWD, PFWD and safety will all be formally assessed as outcome measures at baseline and at 4, 8 and 12 weeks follow-up. Discussion: This trial will be the first of its kind in terms of methodology in relation to ESWT for intermittent claudication. A double-masked randomised controlled trial will provide useful information about the potential for the use of ESWT as a non-invasive treatment option and the need for further robust research. Trial registration: ClinicalTrials.gov, NCT02652078. Registered on 17 October 2014

A Systematic Review of the Uptake and Adherence Rates to Supervised Exercise Programs in Patients with Intermittent Claudication

Background Intermittent claudication (IC) is a common and debilitating symptom of peripheral arterial disease and is associated with a significant reduction in a sufferer's quality of life. Guidelines recommend a supervised exercise program (SEP) as the primary treatment option; however, anecdotally there is a low participation rate for exercise in this group of patients. We undertook a systematic review of the uptake and adherence rates to SEPs for individuals with IC. Methods The MEDLINE, Embase, and PubMed databases were searched up to January 2015 for terms related to supervised exercise in peripheral arterial disease. The review had 3 aims: first, to establish the rates of uptake to SEPs, second, the rates of adherence to programs, and finally to determine the reasons reported for poor uptake and adherence. Separate inclusion and/or exclusion criteria were applied in selecting reports for each aim of the review. Results Only 23 of the 53 potentially eligible articles for uptake analysis identified on literature searches reported any details of screened patients (n = 7,517) with only 24.2% of patients subsequently recruited to SEPs. Forty-five percent of screen failures had no reason for exclusion reported. Sixty-seven articles with 4,012 patients were included for analysis of SEP adherence. Overall, 75.1% of patients reportedly completed an SEP; however, only one article defined a minimal attendance required for SEP completion. Overall, 54.1% of incomplete adherence was due to patient withdrawal and no reason for incomplete adherence was reported for 16% of cases. Conclusions Reporting of SEP trials was poor with regard to the numbers of subjects screened and reasons for exclusions. Only approximately 1 in 3 screened IC patients was suitable for and willing to undertake SEP. Levels of adherence to SEPs and definitions of satisfactory adherence were also lacking in most the current literature. Current clinical guidelines based on this evidence base may not be applicable to most IC patients and changes to SEPs may be needed to encourage and/or retain participants

A systematic review and meta-analysis of systemic intraoperative anticoagulation during arteriovenous access formation for dialysis

Purpose: Surgical arteriovenous fistula (AVF) or graft (AVG) is preferred to a central venous catheter for dialysis access. Surgical access may suffer thrombosis early after placement and systemic anticoagulation during surgical access formation may increase patency rates but would be expected to increase bleeding-related complications. A systematic review and meta-analysis of randomised controlled trials was conducted to examine the impact of systemic anticoagulation on access surgery perioperative bleeding and patency rates. Methods: We included randomised controlled trials testing systemic anticoagulation during access formation versus a control group without systemic anticoagulation reporting bleeding complications and access patency. Medline, Embase, CENTRAL and CINAHL were searched up to March 2015. Risk of bias was assessed using the Cochrane risk of bias tool and the Jadad score. Meta-analysis was performed using Cochrane Revman ® software. Results: Searches identified 445 reports of which four randomised studies involving 411 participants were included. Three studies pertained to AVF only and one included both AVF and AVG. Systemic anticoagulation led to increased bleeding events in all access [four trials; risk ratio (RR) 7.18; confidence interval (CI), 2.41 to 21.38; p < 0.001]. Patency was not improved for all access (four trials; RR, 0.64; CI, 0.37 to 1.09; p = 0.10) but was improved when AVF analysed alone (three trials; RR, 0.57; CI, 0.33 to 0.97; p = 0.04). Conclusions: The use of intraoperative systemic anticoagulation during access formation is associated with a highly significant increased risk of bleeding-related complications. A significant improvement in AVF patency was seen, though not when AVF and AVG were analysed together

Patient and Healthcare Professional Priorities for a Mobile Phone Application for Patients With Peripheral Arterial Disease

Introduction Supervised exercise therapy (SET) is the first-line treatment for the peripheral arterial disease (PAD), however, access and compliance are low. An alternative method of delivering this therapy is through mobile health applications, which can be more accessible and convenient for patients. The aim of this study is to evaluate patient, public and healthcare professional (HCP) priorities with regard to a dedicated mobile phone application to deliver remote SET. Methods Bespoke questionnaires were designed for patients and HCPs to assess app functionality and prioritisations for development. These were distributed through social media and the Norfolk and Norwich University Hospital. Results Functionality questionnaires were completed by 62 patients and 44 HCPs. Eighty-four per cent of patients wanted their therapy to be monitored by their vascular team with the majority (78%) interested in measuring walking distances. Most patients (76%) were interested in watching exercise videos. These views were shared by HCPs. A communication platform was prioritised for messaging and pictures by the patient (74% and 68% respectively), but not so by HCPs (40%). Documenting other forms of physical activity and the use of wearable technology was less valuable to patients but favoured by HCPs (50%). The ability to interact with other users was not prioritised by either group. Conclusion Delivery of a mobile phone application to deliver health programmes for SET in patients with PAD is an acceptable method for patients and HCPs. This data will enable the next stages of mobile phone application development to be appropriately prioritised, focusing on building exercise videos, a communication platform and further walking tests

Validating the Fitbit Charge 4© wearable activity monitor for use in physical activity interventions

OBJECTIVES: Commercially available wearable activity monitors can promote physical activity behaviour. Clinical trials typically quantify physical activity with research grade activity monitors prior to testing interventions utilising commercially available wearable activity monitors aimed at increasing step count. Therefore, it is important to test the agreement of these two types of activity monitors.OBJECTIVES: Observational.METHODS: Thirty adults (20-65 years, n = 19 females) were provided a Fitbit Charge 4©. To determine reliability using an intraclass correlation coefficient, two, one-minute bouts of treadmill walking were performed at a self-selected pace. Subsequently, participants wore both an ActiGraph wGT3X-BT and the Fitbit for seven days. To determine agreement, statistical equivalence and the mean absolute percentage error were calculated and represented graphically with a Bland-Altman plot. Ordinary least products regression was performed to identify fixed or proportional bias.RESULTS: The Fitbit showed 'good' step count reliability on the treadmill (intraclass correlation coefficient = 0.75, 95 % CI = 0.53-0.87, p &lt; 0.001). In free-living however, it overestimated step count when compared to the ActiGraph wGT3X-BT (mean absolute percentage error = 26.02 % ± 14.63). Measurements did not fall within the ± 10 % equivalence region and proportional bias was apparent (slope 95 % CI = 1.09-1.35).CONCLUSIONS: The Fitbit Charge 4© is reliable when measuring step count on a treadmill. However, there is an overestimation of daily steps in free-living environments which may falsely indicate compliance with physical activity recommendations.</p

Extreme low-lying carotid bifurcations

A 52-year-old male with no past medical history was referred to the transient ischaemic attack (TIA) clinic following an event at home. The transient symptoms were of an inability to move his left arm and leg for a period of approximately 15 minutes. The patient denied any numbness of the face, headaches or blurring of vision. A careful history revealed two previous transient attacks of blurred vision approximately 1–2 years prior to this presentation. He had no other co-morbidities or associated syndromes. Given this history, suggestive of TIA(s) in the right anterior circulation, an ultrasound examination of the carotid vessels was performed to include or exclude an atherosclerotic source of embolus. The ultrasound scan demonstrated an extremely short common carotid artery (CCA) of just 2.5 cm on the right, with apparently normal flows and velocities in both the external and internal carotids (ECA and ICA) but poor views of the bifurcation. Similarly, the flows and velocities in the left ICA and ECA were also normal, with the carotid bulb lying low in the base of the neck, so further imaging with a magnetic resonance angiogram (MRA) was performed (Panel A) to clarify the anatomic and ultrasound findings. This confirmed extremely low-lying bilateral carotid bifurcations (highlighted in Panel A). The short, right-side CCA bifurcates at the level of C7/T1 (Panel B) and the left carotid bifurcation is at the level of C6/C7 (Panel C)

Effects of a 10-week integrated curriculum intervention on physical activity, resting blood pressure, motor skills and well-being in 6–7-year-olds

Background: Integrated curriculum interventions have been suggested as an effective means to increase physical activity (PA) and health. The feasibility of such approaches in children living in deprivation is unknown. This study sought to pilot an integrated curriculum pedometer intervention in children living in deprivation on school-based PA, body fatness, resting blood pressure, motor skills and well-being.Methods: Using a pilot cluster randomized intervention design, children (6-7-years-old, n=64) from two schools in central England undertook: (1) 10-week integrated curriculum intervention or (2) control (regular school-based activity). School-based PA, body fatness, resting blood pressure, motor skills and well-being was assessed pre and post intervention.Results: for the intervention group PA was higher on school days when children had PE lessons or there were physically active integrated curriculum activities. Body fatness significantly decreased, wellbeing and perceived physical competence increased, pre-post for the intervention group compared to the control group. Accelerometer derived PA, motor skills and resting blood pressure were not significantly different pre-post for intervention or control groups. Conclusions: A 10-week integrated curriculum PA intervention is feasible to conduct and can positively impact aspects of health in 6–7-year-old children in England.<br/

A systematic review of high-intensity interval training as an exercise intervention for intermittent claudication

BackgroundIntermittent claudication (IC) is the most common symptom of peripheral arterial disease, which significantly affects walking ability, functional capacity and quality of life. Supervised exercise programs (SEP) are recommended as first-line treatment, but recruitment and adherence rates are poor. The time required to complete a SEP is the most common barrier to participation cited by patients who decline. High-intensity interval training (HIIT) is more time efficient than current SEPs and therefore has the potential to overcome this barrier. We conducted a systematic review to appraise the evidence for HIIT programs for IC.MethodsMEDLINE, Embase, and CENTRAL databases were searched for terms related to HIIT and IC. Randomized and nonrandomized trials that investigated HIIT for the treatment of IC were included, with no exclusions based on exercise modality, protocol, or use of a comparator arm. Outcome measures were walking distances, peak oxygen uptake, recruitment and adherence rates, and quality of life. The risk of bias was assessed using the Cochrane tool and study quality using a modified Physiotherapy Evidence Database scale.ResultsNine articles reporting eight studies were included in the review. HIIT seems to improve walking distances and oxygen uptake in relation to controls, with improvements attainable in just 6 weeks. When HIIT was compared with low-intensity exercise, it seemed that longer low-intensity programs were required to obtain similar benefits to those from short-term HIIT.ConclusionsInitial evidence suggests that HIIT may provide benefits for patients with IC. Initially, pilot studies of low-volume, short-term HIIT vs usual SEPs are required. This strategy will allow for larger randomized, controlled trials to be appropriately designed and adequately powered to further explore the potential benefits of HIIT in IC