Efficacy of brief behavioral counselling by allied health professionals to promote physical activity in people with peripheral arterial disease (BIPP): study protocol for a multi-center randomized controlled trial

Background: Physical activity is recommended for people with peripheral arterial disease (PAD), and can improve walking capacity and quality of life; and reduce pain, requirement for surgery and cardiovascular events. This trial will assess the efficacy of a brief behavioral counselling intervention delivered by allied health professionals to improve physical activity in people with PAD. Methods: This is a multi-center randomised controlled trial in four cities across Australia. Participants (N = 200) will be recruited from specialist vascular clinics, general practitioners and research databases and randomised to either the control or intervention group. Both groups will receive usual medical care, a written PAD management information sheet including advice to walk, and four individualised contacts from a protocol-trained allied health professional over 3 months (weeks 1, 2, 6, 12). The control group will receive four 15-min telephone calls with general discussion about PAD symptoms and health and wellbeing. The intervention group will receive behavioral counselling via two 1-h face-to-face sessions and two 15-min telephone calls. The counselling is based on the 5A framework and will promote interval walking for 3 × 40 min/week. Assessments will be conducted at baseline, and 4, 12 and 24 months by staff blinded to participant allocation.Objectively assessed outcomes include physical activity (primary), sedentary behavior, lower limb body function, walking capacity, cardiorespiratory fitness, event-based claudication index, vascular interventions, clinical events, cardiovascular function, circulating markers, and anthropometric measures. Self-reported outcomes include physical activity and sedentary behavior, walking ability, pain severity, and health-related quality of life. Data will be analysed using an intention-to-treat approach. An economic evaluation will assess whether embedding the intervention into routine care would likely be value for money. A cost-effectiveness analysis will estimate change in cost per change in activity indicators due to the intervention, and a cost-utility analysis will assess change in cost per quality-adjusted life year. A full uncertainty analysis will be undertaken, including a value of information analysis, to evaluate the economic case for further research. Discussion: This trial will evaluate the efficacy and cost-effectiveness of a brief behavioral counselling intervention for a common cardiovascular disease with significant burden. Trial registration: ACTRN 12614000592640 Australian New Zealand Clinical Trials Registry. Registration Date 4 June 2014

The Effect of Supervised Exercise Therapy on Physical Activity and Ambulatory Activities in Patients with Intermittent Claudication

Objective/BackgroundIntermittent claudication (IC) is associated with a reduction in physical activity (PA) and a more rapid functional decline leading to a higher mortality rate compared with healthy individuals. Supervised exercise therapy (SET) is known to increase the walking capacity of patients with IC. However, it is unclear whether SET increases PA. The aim of this study was to investigate the effect of SET on PA levels and ambulatory activities in patients with IC.MethodsPatients newly diagnosed with IC were requested to wear an activity monitor 1 week prior to and 1 week immediately after 3 months of SET. The primary outcome was the percentage of patients meeting the minimum recommendations of PA (American College of Sports Medicine [ACSM]/American Heart Association [AHA] recommendation for public health of ≥ 67 metabolic equivalents [METs]/min/day, in bouts of ≥ 10 min) at baseline and after 3 months of SET. Additionally, daily PA level (METs/min), duration of ambulatory activities, daily number of steps, pain free walking distance (PFWD), maximal walking distance (MWD), and Short Form Health Survey (SF-36) health surveys were compared before and after SET.ResultsData from 41 participants were available for analysis. A higher number of participants met the ACSM minimum recommendation for PA at the 3 month follow up (baseline: 43%; 3 months: 63%; p = .003). Despite significant increases in PFWD (baseline: 210 m; 3 months: 390 m; p = .001), MWD (baseline: 373 m; 3 months: 555 m; p = .002) and physical functioning score (SF-36) following SET, no increase in the mean daily PA level was found (395 ± 220 vs. 411 ± 228 METs/min; p = .43). Furthermore, the total number of steps and time spent in ambulatory activities did not change following SET.ConclusionThree months of SET for IC leads to more patients meeting the ACSM/AHA public health minimum recommendations for PA. Assessment of PA could be incorporated as an outcome parameter in future research comparing different treatment modalities for peripheral arterial disease

Risk factors for mortality and failure of conservative treatment after aortic type B dissection

BackgroundDespite medical treatment, one third of patients with uncomplicated type B aortic dissections experience severe late complications. The aim of this study was to identify patients at high risk of mortality during follow-up.MethodsA total of 183 patients with acute Stanford type B dissection were treated in one of the university hospitals (Aachen [Germany], Maastricht [The Netherlands], and Innsbruck [Austria]) between 1997 and 2010. Records indicated that 120 patients were treated conservatively. Of these patients, 16 were lost to follow-up. The maximum diameter, extent of the dissection, and patency of the side branches were determined from computed tomography angiography data. Survival and treatment failure were analyzed by univariate and multivariate Cox regression analysis. The univariate analysis investigated the influence of aortic diameter (≥41 vs <41 mm) on survival, and the multivariate analysis investigated the influence of aortic diameter, age, sex, and surgery on survival.ResultsDuring the follow-up period, the initial treatment was converted to surgical treatment in 21 patients (20.2%). Sixteen of the 104 patients (15.4%) died after a mean of 845.5 ± 805.9 days. The mean maximum aortic transversal diameter at admission was 41.2 ± 8.7 mm. The multivariate analysis identified aortic diameter (P = .004; hazard ratio, 1.07) and age (P = .038; hazard ratio, 1.05) as risk factors that significantly reduce survival.ConclusionsOur study revealed both early aortic dilatation and older age as risk factors for increased mortality after conservative treatment of type B dissection

A multicentre trial of patient specific rehearsal prior to EVAR:Impact on Procedural Planning and Team Performance

\u3cp\u3eObjective Patient specific rehearsal (PsR) prior to endovascular aneurysm repair (EVAR) enables the endovascular team to practice and evaluate the procedure prior to treating the real patient. This multicentre trial aimed to evaluate the utility of PsR prior to EVAR as a pre-operative planning and briefing tool. Material and methods Patients with an aneurysm suitable for EVAR were randomised to pre-operative or post-operative PsR. Before and after the PsR, the lead implanter completed a questionnaire to identify any deviation from the initial treatment plan. All team members completed a questionnaire evaluating realism, technical issues, and human factor aspects pertinent to PsR. Technical and human factor skills, and technical and clinical success rates were compared between the randomised groups. Results 100 patients were enrolled between September 2012 and June 2014. The plan to visualise proximal and distal landing zones was adapted in 27/50 (54%) and 38/50 (76%) cases, respectively. The choice of the main body, contralateral limb, or iliac extensions was adjusted in 8/50 (16%), 17/50 (34%), and 14/50 (28%) cases, respectively. At least one of the abovementioned parameters was changed in 44/50 (88%) cases. For 100 EVAR cases, 199 subjective questionnaires post-PsR were completed. PsR was considered to be useful for selecting the optimal C-arm angulation (median 4, IQR 4-5) and was recognised as a helpful tool for team preparation (median 4, IQR 4-4), to improve communication (median 4, IQR 3-4), and encourage confidence (median 4, IQR 3-4). Technical and human factor skills and technical and initial clinical success rates were similar between the randomisation groups. Conclusion PsR prior to EVAR has a significant impact on the treatment plan and may be useful as a pre-operative planning and briefing tool. Subjective ratings indicate that this technology may facilitate planning of optimal C-arm angulation and improve non-technical skills. Trial registration: URL://www.clinicaltrials.gov. Unique identifier: NCT01632631.\u3c/p\u3